Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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Dr Mohan Z Mani

"Thank you very much for having published my article in record time.I would like to compliment you and your entire staff for your promptness, courtesy, and willingness to be customer friendly, which is quite unusual.I was given your reference by a colleague in pathology,and was able to directly phone your editorial office for clarifications.I would particularly like to thank the publication managers and the Assistant Editor who were following up my article. I would also like to thank you for adjusting the money I paid initially into payment for my modified article,and refunding the balance.
I wish all success to your journal and look forward to sending you any suitable similar article in future"



Dr Mohan Z Mani,
Professor & Head,
Department of Dermatolgy,
Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



Dr Kalyani R
Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
‘Knowledge is treasure of a wise man.’ The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
As an experienced dentist and an academician, I proudly recommend this journal to the dental fraternity as a good quality open access platform for rapid communication of their cutting-edge research progress and discovery.
I wish JCDR a great success and I hope that journal will soar higher with the passing time."



Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Research Protocol
Year : 2023 | Month : September | Volume : 17 | Issue : 9 | Page : PK01 - PK04 Full Version

Comparison of Scar Quality using Polyglactin and Polyamide Suture Materials for Closure of Nasolabial Flap Donor Site Defects in Patients with Oral Submucous Fibrosis: A Research Protocol


Published: September 1, 2023 | DOI: https://doi.org/10.7860/JCDR/2023/58751.18467
Gauri Sharma, Deepankar Shukla, Nitin Bhola

1. Postgraduate Trainee, Department of Oral and Maxillofacial Surgery, Sharad Pawar Dental College and Hospital, Wardha, Maharashtra, India. 2. Associate Professor, Department of Oral and Maxillofacial Surgery, Sharad Pawar Dental College and Hospital, Wardha, Maharashtra, India. 3. Professor and Head, Department of Oral and Maxillofacial Surgery, Sharad Pawar Dental College and Hospital, Wardha, Maharashtra, India.

Correspondence Address :
Gauri Sharma,
Radhikabai Girls Hostel, Sawangi, Wardha-442004, Maharashtra, India.
E-mail: dr.gaurisharma.20@gmail.com

Abstract

Introduction: Scar formation is an unavoidable sequelae of any surgical procedure. The goal is to produce fine scars with the least complications. Literature mentions various surgical factors that may lead to better quality of scars, one of which is the type of suture material used. Few studies exist in the literature that have compared the quality of scars after placement of polyglactin and polyamide sutures. Additionally, no studies have been done to compare the quality of scars following reconstruction with nasolabial flaps in patients with oral submucous fibrosis.

Need for the study: This study will help evaluate and establish the healing outcomes in nasolabial flaps in the form of scars after placing subcutaneous 4-0 polyglactin (VICRYL™ ETHICON) and 4-0 polyamide (ETILONTM ETHICON) sutures. This will eventually lead to minimal tissue reaction and more aesthetic scars with fewer complications.

Aim: To evaluate and compare the quality of scars post-reconstruction with nasolabial flaps with subcutaneous polyglactin sutures and subcutaneous polyamide sutures.

Materials and Methods: This is a prospective randomised triple-blinded trial which will be conducted in the Department of Oral and Maxillofacial Surgery, Sharad Pawar Dental College and Hospital (SPDCH), Sawangi (Meghe), Wardha, India. The trial will take place from July 2023 to June 2024. A total of 15 subjects with grade C Oral and Submucous Fibrosis (OSMF), who will undergo fibrotomy followed by reconstruction of bilateral nasolabial flaps, will be enrolled in the trial. Suturing of one side of the flap will be done using 4-0 polyglactin (VICRYL™ ETHICON) suture subcutaneously, and the other side will use 4-0 polyamide (Ethilon™ ETHICON) suture subcutaneously. The scar tissues will be periodically evaluated at one week, one month, and three months postoperative period to assess the healing outcomes and overall aesthetic appearance using the Patient and Observer Scar Assessment Scale (POSAS) using Chi-square test and Student’s t-test.

Keywords

Non absorbable suture, Scar outcomes, Wound healing

Scar formation is an inevitable sequelae of the healing process in surgical incisions. However, the aim is to have a fine scar with minimum colour changes and no inflammatory reactions (1). Wound healing is an intricate procedure that involves the steps of inflammation, proliferation, and remodeling. Out of these, the remodeling phase is the most responsible for the quality of scar produced (2). Literature mentions various surgical factors which may lead to better quality of scars, such as the use of proper aseptic techniques, optimum handling of tissues, placement of incision along the skin tension lines, approximation of tissues to cause wound eversion, and the choice of suture material [3,4]. The local inflammatory response caused by the suture is implicated in the extent of residual scar formation (4). An ideal suture will produce the best possible healing outcome in scar tissue with little or no undesirable reactions, such as tissue reactivity, pruritus, and wound dehiscence. This is essential for the overall healing of wounds and the acceptable appearance of scar tissues. Suture materials can be broadly classified as monofilament and multifilament based on the physical configuration. VICRYL™ sutures are multifilament synthetic absorbable sutures that are a copolymer of lactide and glycolide with polyglactin 370 and calcium stearate coating. They are a popular choice of suture material in plastic surgery. VICRYL™ sutures are absorbed by a process called hydrolysis after 56 to 70 days of placement (5). Monofilament synthetic non absorbable Nylon polyamide sutures, such as Ethilon™, have excellent tensile strength when compared to other sutures. Ethilon™ sutures have extremely low tissue reactivity, which is a useful quality for obtaining favorable scar formation (5).

Concerns exist regarding the use of braided sutures for epidermal wound closure. Braided sutures harbour microbes, which could lead to increased chances of inflammation, wound infection, and subsequently poor wound healing and scar appearance (6). Multifilament sutures, when used subcutaneously, tend to extrude as localised abscesses, whereas monofilament sutures produce far less tissue reactions (5). A randomised trial by Asher R et al., compared the colony-forming units in monofilament and multifilament suture materials and concluded that bacterial adhesion differs between various suture materials, with bacterial adhesion being lowest in nylon sutures compared to silk, coated polyglactin, and polyester sutures (7).

Nasolabial flaps were first mentioned and described in literature in 600 BC by Sushruta. The use of these flaps for the reconstruction of oral defects developed in Europe in the 20th century after work by Thiersch and later Esser (8). The nasolabial flap has reduced donor-site morbidity frequently associated with other flaps. It makes postoperative rehabilitation easier by providing adequate bulk at the recipient site. The nasolabial flap is easily accessible and quick to harvest, which reduces operating time (9). Despite its advantages, nasolabial flaps are associated with problems such as hair growth intraorally, temporary widening of the mouth, and the development of unappealing scars (10).

Few studies exist in the literature that have compared the quality of scars after placement of polyglactin and polyamide sutures [6,11-14]. Additionally, no studies have been done to compare the quality of scars following reconstruction with nasolabial flaps in patients with oral submucous fibrosis. Hence, the present study is designed to assess and draw comparisons in the quality of scars post-reconstruction with nasolabial flaps with subcutaneous polyglactin sutures and subcutaneous polyamide sutures.

Aim

• To evaluate the scar quality as evaluated by the “POSAS” after using 4-0 polyglactin (VICRYL™ ETHICON) sutures for closure of the nasolabial defect at the donor site with the subcuticular suturing technique following reconstruction of the surgical defect post fibrotomy with a nasolabial flap in patients with oral submucous fibrosis.
• To evaluate the scar quality as assessed by the “POSAS” after using 4-0 polyamide (Ethilon™ ETHICON) sutures for closure of the nasolabial defect at the donor site with the subcuticular suturing technique following reconstruction of the surgical defect post fibrotomy with a nasolabial flap in patients with OSMF.
• To compare the scar quality as assessed by the “POSAS” after using 4-0 Polyglactin (VICRYL™ ETHICON) sutures and 4-0 polyamide (Ethilon™ ETHICON) sutures for closure of the nasolabial defect at the donor site with the subcuticular suturing technique following reconstruction of the surgical defect post fibrotomy with a nasolabial flap in patients with OSMF.

Null hypothesis: Subcutaneous Ethilon™ suture is similar to subcutaneous VICRYL™ suture for closure of the nasolabial defect following reconstruction with a nasolabial flap in patients with oral submucous fibrosis.

Alternate hypothesis: Subcutaneous Ethilon™ suture is better than subcutaneous VICRYL™ suture for closure of the nasolabial defect following reconstruction with a nasolabial flap in patients with oral submucous fibrosis.

REVIEW OF LITERATURE

The face is the identity of an individual and is directly related to an individual’s self-esteem. It is for this reason that excessive postsurgical scarring in highly aesthetic zones, such as the face, leads to increased patient dissatisfaction and poor acceptance of surgery. The nature of suture material has been implicated in the final cosmetic outcome of wounds. This is supported by an early study conducted by GoulbourneI IA et al., in 1988 (11), where they compared the aesthetics, undesirable outcomes, and patient preference between polyglactin sutures and polyamide sutures placed subcutaneously in varicose vein surgery. They concluded that the wound support provided by polyglactin sutures is responsible for better healing outcomes. Subcuticular suturing should be the technique of choice for skin closure, and polyglactin 910 (VICRYL™) is possibly the best suited for it.

In another study by Yang J et al., the cosmetic appearance and overall patient satisfaction were compared between subcuticular sutures using non absorbable non braided sutures and intradermal mattress sutures placed using absorbable multifilament sutures (12). They concluded that the buried mattress sutures placed with absorbable multifilament sutures had better cosmetic outcomes compared to subcuticular sutures placed using non absorbable non braided sutures.

However, more recent studies suggest that the nature of the suture material plays little or no role in the aesthetics of scar tissue. In a 2019 randomised controlled trial by Moran B et al., epidermal scars on the face were sutured with absorbable Polyglactin 910 on one part of the wound and nylon on the other part (6). The postsurgical scars were graded after six months using photographs by a dermatologist and a plastic surgeon. They concluded that epidermally placed absorbable polyglactin and nylon sutures resulted in an equivalent photographic appearance of facial scars six months after surgery. This finding is further supported by a systematic review and meta-analysis by Gillanders SL et al., which assessed whether non absorbable or absorbable suture materials vary in aesthetic appearance in the closure of facial wounds (15). They concluded that absorbable and non absorbable sutures produced similar cosmetic appearances.

The appearance of scar tissue is intimately linked to its healthy healing process. It has been hypothesised that braided sutures harbour more microorganisms and are therefore more prone to infections and stitch abscesses compared to non braided sutures. In a 2019 randomised controlled trial, Dragovic M et al., compared four sutures in terms of wound healing, microbial colony formation, and tissue reactions in third molar extraction sites (16). They concluded that non braided synthetic sutures should be used to achieve superior healing of soft tissues and decrease the chances of infection in oral surgical procedures. However, this is in contrast with another randomised controlled trial by Koroglu N et al., that compared the frequency of infection in surgical wounds in females who underwent caesarean section with skin closure subcuticually with polyglactin 910 or polypropylene sutures (17). They concluded that wound infections and other complications were similar with polyglactin 910 and polypropylene sutures.

Unsightly scars post surgery can increase the need for additional corrective surgeries, adding to patient morbidity. It is thus imperative to produce scars that have an acceptable size and colour with no signs of inflammation, infection, dehiscence, or necrosis.

Material and Methods

This will be a prospective randomised triple-blinded trial conducted from July 2023 to June 2024 in the Department of Oral and Maxillofacial Surgery at Sharad Pawar Dental College and Hospital (SPDCH) Sawangi (Meghe), Wardha, Maharashtra, India. A total of 15 subjects will be included in the study.

Trial registration number: CTRI/2023/07/054827.

Ethics and dissemination: The trial has been approved by the Institutional Ethical Committee (IEC) (DMIMS(DU)/IEC/2022/772), Datta Meghe Institute of Medical Sciences Sawangi, Wardha, Maharashtra, India.

Sample size calculation:

n=Z2 P(1-P)/ d2

where n=Sample size,
Z=Z statistic for a level of confidence,
P=Expected prevalence or proportion, and
d=Precision
For a level of significance at 5% (95% confidence interval), Z=1.96.
P=Prevalence of OSMF (oral submucous fibrosis)=1.97%=0.0197 (reference: Bhatnagar SU et al., (18)).
d=Desired error margin=7%=0.07.
n=1.962 * 0.0197 * (1-0.0197) / 0.072=15.14. Rounded to 15.
Power of test: 80%
Level of significance: 5%

Inclusion criteria:

• Individuals with stage C OSMF {according to Haider SM et al., classification (19)} who are medically fit to undergo surgery under general anaesthesia.
• Individuals belonging to ASA 1 (American Society of Anesthesiologists physical status classification).
• Individuals who give consent for reconstruction using a nasolabial flap.

Exclusion criteria:

• Individuals with a known tendency of keloid formation and/or previous history of hypertrophic scar.
• Individuals with a prior history of radiation in the head and neck region.
• Individuals with medical conditions affecting the jaws.
• Patients with superimposed premalignant or cancerous lesions.
• Patients who have been previously operated for OSMF.
• Individuals unwilling to give consent for the study.

Primary outcomes:

• Evaluation of the scar quality after using 4-0 polyglactin (VICRYL™ ETHICON) sutures for closure of the nasolabial defect at the donor site with the subcuticular suturing technique following reconstruction of the surgical defect in patients with oral submucous fibrosis.
• Evaluation of the scar quality after using 4-0 polyamide (Ethilon™ ETHICON) sutures for closure of the nasolabial defect at the donor site with the subcuticular suturing technique following reconstruction of the surgical defect in patients with oral submucous fibrosis.
• Comparison of the scar quality after using 4-0 polyglactin (VICRYL™ ETHICON) sutures and 4-0 polyamide (Ethilon™ ETHICON) sutures for closure of the nasolabial defect at the donor site with the subcuticular suturing technique following reconstruction of the surgical defect in patients with oral submucous fibrosis.

Secondary outcomes:

• Evaluation of the total time required for suturing after using 4-0 polyglactin (VICRYL™ ETHICON) sutures for closure of the nasolabial defect at the donor site with the subcuticular suturing technique following reconstruction of the surgical defect in patients with oral submucous fibrosis.
• Evaluation of the total time required for suturing after using 4-0 polyamide (Ethilon™ ETHICON) sutures for closure of the nasolabial defect at the donor site with the subcuticular suturing technique following reconstruction of the surgical defect in patients with oral submucous fibrosis.

A total of 15 subjects will be included in the study. A detailed case history of these subjects will be taken, and they will be explained the entire surgical procedure. Informed consent will be obtained from each participant. The fibrotomy procedure will be performed, and the surgical defect will be closed using a nasolabial flap under general anesthesia at Siddharth Gupta Memorial Cancer Hospital, Sawangi, Wardha. One side of the flap will be sutured using 4-0 Polyglactin (VICRYL™ ETHICON) sutures subcutaneously, and the other side will be sutured using 4-0 polyamide (Ethilon™ ETHICON) sutures subcutaneously. The sutures will be tensioned appropriately to ensure complete wound edge apposition without causing blanching. Standard postoperative wound care measures will be followed, and patients will be given Tback ointment for local application for seven days after suture removal.

The trial will be discontinued for a participant under the following conditions:

- At the request of the participant
- Development of an allergic reaction after placement of sutures
- Emergence of any life-threatening situations

The scar tissues will be evaluated at one week, one month, and three months postoperatively to assess the healing outcomes using the Patient and Observer Scar Assessment Scale (POSAS) proposed by Van de Kar AL et al., (20). The scars will be evaluated based on the following parameters:

Assessment criteria in the observer scale (20):

• Vascularity of the scar, which will be assessed by the amount of blood return when the scar tissue is pressed with a piece of plexiglas.
• Scar pigmentation will be seen as brownish colour of the scar due to melanin pigmentation. To eliminate the colour changes due to vascularity, the scar will be pressed using plexiglas.
• Thickness of the scar, measured as the mean distance from the subcuticular-dermal junction to the epidermal surface of the scar.
• Relief of the scar, denoted by the presence of surface unevenness compared to the nearby normal area.
• Pliability of the scar, tested by pressing the scar between two fingers.
• Total area of the scar in relation to the original wound area.
• Overall opinion regarding the aesthetics of the scar tissue.

Assessment criteria in the patient scale (20):

• Presence and extent of pain in the scar tissue.
• Itching, if present in association with the scars.
• Extent of colour difference between the normal tissue and the scar tissue.
• Irregularity of the scar compared to the nearby normal area.
• Stiffness of the scar compared to the adjoining areas.
• Thickness of the scar tissue compared to normal skin.
• Overall opinion of the scars compared to normal skin.
The scoring will be done on a rating scale numbered from 0 to 10.

Methods: Assignment of interventions (for controlled trials):

Allocation:

- Sequence generation: The allocation sequence will be generated using a random table of numbers.
- Implementation: The primary investigator will be responsible for generating the allocation sequence, enrolling participants, and assigning them to interventions. The suture materials will be randomly assigned to the left or right side of the nasolabial flap donor site defects for subcuticular skin closure.

Blinding (masking):

- The trial participants, outcome assessors, and the statistician will be blinded.

Data collection, management, and analysis methods:

- Data collection methods: Data will be collected based on the inputs entered in the POSAS questionnaires.
- Data management: All protocol-related data will be recorded in the POSAS questionnaires.
- Statistical methods: Statistical analysis will be performed using Chi-square test and Student’s t-test. The software used for analysis will be SPSS 27.0V and GraphPad Prism 7.0V at a 5% level of significance.

Consent or assent:

- Informed consents will be obtained using printed consent forms by the primary investigator.

Confidentiality:

- All details of enrolled participants will be handwritten in pre-printed POSAS proformas. The contents will be kept confidential unless there is a need to share patient-related information for trial-related reasons.

Declaration of interests:

- Financial and other competing interests of the principal investigators for the overall trial and each study site will be declared.

Ancillary and post-trial care:

- In case of undesirable outcomes following surgery, the study participants will be suitably compensated.

Dissemination policy:

- The results of the trial will be published in a reputed journal. The study may also be presented as a paper in any state or national-level conference.

References

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Shetty RK, Pradhan S, Kannan R, Doctor A, Surnare K, Jondhale M, et al. Clinical profile and quality of life assessment of oral cancer patients following nasolabial flap reconstruction surgery. Indian Journal of Otolaryngology and Head & Neck Surgery. 2020;72(2):200-07. [crossref][PubMed]
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Patil SB, Durairaj D, Kumar GS, Karthikeyan D, Pradeep D. Comparison of extended nasolabial flap versus buccal fat pad graft in the surgical management of oral submucous fibrosis: A prospective pilot study. Journal of Maxillofacial and Oral Surgery. 2017;16(3):312-21. [crossref][PubMed]
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Yang J, Kim KH, Song YJ, Kim SC, Sung N, Kim H, et al. Cosmetic outcomes of cesarean section scar; subcuticular suture versus intradermal buried suture. Obstetrics & Gynecology Science. 2018;61(1):79-87. [crossref][PubMed]
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PatelK, Rabari M, Jain AP, Saxena AK. Comparison between interrupted vertical mattress suture versus skin stapler versus subcuticular suture for skin closure in clean surgery. Int J Res Med. 2014;3(3):164-68.
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Menovsky T, Bartels RH, van Lindert EL, André Grotenhuis J. Skin closure in carpal tunnel surgery: A prospective comparative study between nylon, polyglactin 910 and stainless steel sutures. Hand Surgery. 2004;9(01):35-38. [crossref][PubMed]
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Gillanders SL, Anderson S, Mellon L, Heskin L. A systematic review and meta- analysis: Do absorbable or non-absorbable suture materials differ in cosmetic outcomes in patients requiring primary closure of facial wounds? Journal of Plastic, Reconstructive & Aesthetic Surgery. 2018;71(12):1682-92. [crossref][PubMed]
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Dragovic M, Pejovic M, Stepic J, Colic S, Dozic B, Dragovic S, et al. Comparison of four different suture materials in respect to oral wound healing, microbial colonization, tissue reaction and clinical features-randomized clinical study. Clinical Oral Investigations. 2020;24(4):1527-41. [crossref][PubMed]
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Koroglu N, TemelYuksel I, Aslan Cetin B, Aytufan Z, Deniz N, Akca A, et al. Skin closure at cesarean section, polypropylene versus polyglactin 910: A randomized controlled study. The Journal of Maternal-Fetal & Neonatal Medicine. 2022;35(6):1088-92. [crossref][PubMed]
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DOI and Others

DOI: 10.7860/JCDR/2023/58751.18467

Date of Submission: Jun 28, 2022
Date of Peer Review: Sep 22, 2022
Date of Acceptance: Jul 05, 2023
Date of Publishing: Sep 01, 2023

AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. Yes

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Jun 29, 2022
• Manual Googling: Feb 14, 2023
• iThenticate Software: Jul 01, 2023 (10%)

ETYMOLOGY: Author Origin

EMENDATIONS: 5

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