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

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Department of General Medicine,
Belgaum Institute of Medical Sciences,Belgaum, Karnataka,INDIA,
On 30 Nov 2018




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Super Speciality Paediatric Hospital and Post Graduate Teaching Institute, Noida
On Sep 2018




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Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

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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

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Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

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




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




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Best regards,
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Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




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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.
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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.
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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

Important Notice

Original article / research
Year : 2012 | Month : May | Volume : 6 | Issue : 3 | Page : 423 - 427

Amniotic Membrane Dressing versus Normal Saline Dressing in Non-healing Lower Limb Ulcers: A Prospective Comparative Study at a Teaching Hospital

Hanumanthappa M.B., Gopinathan S., Rithin Suvarna, Guruprasad Rai D., Gautham Shetty, Karan Shetty, Sanjeeva Shetty, Zuhail Nazar

1. Corresponding Author, 2. Assistant Professor, Department of Surgery, 3. Associate Professor, Department of Surgery, 4. Resident, Department of Surgery, 5. Resident, Department of Surgery, 6. Resident, Department of Surgery, 7. Resident, Department of Surgery, 8. Resident, Department of Surgery, AJ Institute of Medical Sciences, Mangalore, India.

Correspondence Address :
Hanumanthappa M.B.
AJ Institute of Medical Sciences, Department of Surgery,
Mangalore, India - 575004.
Phone: 9845170266
E-mail: mb.hanumanthappa@gmail.com

Abstract

Background and Objectives: The management of non-healing leg ulcers poses a great challenge because of their high prevalence, refractory nature and their economic consequences on the health care system. Autologous skin graft, which is the current treatment of choice, creates a wound at the donor site. Although bioengineered skin substitutes are available, they are too expensive for the routine clinical use. The amniotic membrane (AM) drew our interest because of its successful use in ophthalmology since long and because of its properties of promoting epithelialization and granulation, infection controlling and pain reducing. Furthermore, it is cheap, easily available, easy to preserve and apply. Hence, we undertook this study to evaluate the effects and the safety of the AM dressing.

Materials and Methods: This prospective and comparative study was conducted at the A.J. Medical College Hospital, Mangalore, from Dec 2009 to Dec 2011. We studied 200 cases with chronic leg ulcers which were divided equally and randomly into the test group (which underwent the AM dressing) and the control group (which underwent the saline dressing). The inclusion criteria were: age of 18 years or older; the presence of at least one lower limb ulcer with a minimum size of 5x5cm; and no tendency for healing in the past 3 months despite conventional medical treatment. They were visually analyzed at intervals of 7, 14 and 21 days for epithelialization, percentages of granulation tissue formation, prevention of infection, exudation, and pain control. The AM grafts were prepared from placentas which were harvested during caesarean sections. Eligible donor mothers who tested negative for HIV, Hepatitis B and C, syphilis, toxoplasmosis, and cytomegalovirus were chosen.

Results: Epithelialization was observed in 88% of the cases in the study group (in the control group, it was 52%), the percentage of the granulation tissue increased significantly from 20% to 80%, the infection rate was 13 % in the test group (it was 59% in the control group), absence of exudation was noted in 69% cases of the test group (it was noted in 29% cases in the control group) and the pain score dropped from 70 to 10. No adverse effects were observed.

Statistical Analysis Used: Chi-square and P value. Conclusion: We conclude that the AM dressing is a safe, cheap and effective alternative method for treating non-healing leg ulcers.

Keywords

Amniotic membrane, Biological dressing, Non-healing ulcer, Leg ulcer

How to cite this article :

Hanumanthappa M.B., Gopinathan S., Rithin Suvarna, Guruprasad Rai D., Gautham Shetty, Karan Shetty, et al.. AMNIOTIC MEMBRANE DRESSING VERSUS NORMAL SALINE DRESSING IN NON-HEALING LOWER LIMB ULCERS: A PROSPECTIVE COMPARATIVE STUDY AT A TEACHING HOSPITAL. Journal of Clinical and Diagnostic Research [serial online] 2012 May [cited: 2019 Aug 19 ]; 6:423-427. Available from
http://www.jcdr.net/back_issues.asp?issn=0973-709x&year=2012&month=May&volume=6&issue=3&page=423-427&id=2069

INTRODUCTION
The management of non-healing leg ulcers poses a great clinical challenge because of their high prevalence, refractory nature, their impact on the patients’ quality of life and their economic consequences on the health care system (1). The current treatment of choice for these recalcitrant ulcers is autologous skin graft. But this usually requires hospitalization for several days and it creates a donor wound. Commercially available allogeneic skin substitutes are too expensive for the routine clinical use (2). The amniotic membrane (AM) is a tissue of particular interest. Its properties such as lack of immunogenicity, fluid loss controlling, pain relieving, reepithelialization and granulation and its stimulating, antiinflammatory, antifibrotic and antimicrobial properties make it an ideal biological dressing (3),(4),(5),(6),(7),(8),(9),(10),(11). It has the advantage of ready availability at no extra cost to the patient (6), (12).

It has been in use in ophthalmology for a long time. Based on its success which was observed in ophthalmology, we wished to evaluate AM as a wound dressing in chronic leg ulcers. We thus undertook a prospective comparative study (AM dressing vs normal saline dressing on 100 cases each) on patients with chronic leg ulcers to evaluate the effects and the safety of the AM dressing.

Material and Methods

This prospective and comparative study was conducted in the Department of Surgery, AJ Institute of Medical Sciences, Mangalore, India, from Dec 2009 to Dec 2011.

Patients
A total of 200 cases were studied, which were equally and randomly divided into the control and the test groups. The patients who presented with non-healing lower limb ulcers formed the subjects for the study. Informed consent and clearance from the local ethical committee were obtained.

The inclusion criteria were:
age of 18 years or older; the presence of at least one lower limb ulcer with a minimum size of 5x5cm; and no tendency for healing in the past 3 months despite conventional medical treatment.

Patients with tubercular and malignant ulcers and burns were excluded from the study. Patients with severe systemic diseases and major bone exposure in the ulcer floors were also not included. The selected patients were admitted and they underwent a detailed clinical examination. The routine haematological investigations and the culture sensitivity of the wound swab were performed for allthe cases, while the special investigations like X-ray of the part and edge biopsy were performed as and when they were required. The patients underwent treatment for a period of one to two weeks before the study to stabilize the wound and appropriate medical and surgical lines of treatment like diabetes control, control of the infection by initiating the appropriate antibiotic based on the culture sensitivity report, surgical debridement, and correction of the medical illness were carried out during this period.

Once the ulcers showed signs of granulation tissue, they were subjected to the study. Prior to the study, a repeat culture swab was taken from each ulcer. Streptococci, if present, were treated with appropriate antibiotics and the patients were then subjected to the study when their cultures showed no growth. Then, the eligible patients were divided randomly into the test and the control groups.

Amniotic membrane (harvesting, preservation and its application):
The AM grafts were prepared from placentas which were harvested during caesarean sections. Eligible donor mothers were accepted for the AM donation after a medical interview and after a written informed consent was obtained from them. Their blood samples were tested for HIV, Hepatitis B and C, syphilis, toxoplasmosis, and cytomegalovirus (13). Those who tested negative, with no premature rupture of the membranes, were chosen for the donation.

The AMs were separated from the chorions of the placentas under sterile aseptic conditions (Table/Fig 1). The AMs were cleared of all gross tissue attachments and blood clots by washing them in copious amounts of normal saline. The membranes were then placed in large bottles which contained 85% glycerol and they were stored at room temperature for 24 hours and then at 4oC in the refrigerator until use. The membranes were tested for bacterial count and culture sensitivity prior to their use. At the time of application, the AMs were thawed by soaking them in normal saline for 10 minutes. They were then spread over the surface of the ulcers and a non-occlusive dressing was placed over them.

Method of application of the dressing:
Test group: The ulcers were cleaned and irrigated with saline, the AMs were applied with their rough (chorionic) surfaces facing the surface of the ulcers and a 3 layered gauze dressing was placed (14), (15). The dressing was left in place for 4 days and it was observed for any exudation. Thereafter, a redressing was done once in 3 days and it was evaluated on the 7th, 14th and 21st days.

Control group:
The ulcers were cleaned and subjected to normal saline dressing once or twice daily, depending on the exudates.

Method of evaluation of the wound:
At the end of the 1st, 2nd and 3rd weeks, the test group (AM dressing) and the control group (normal saline dressing) were evaluated and compared. The parameters which were recorded at each evaluation were epithelialization of the ulcer, percentages of granulation tissue, the local pain score, exudation and prevention of wound infection. The local pain score was assessed by using a 101-point (0–100) visual analogue scale, with 0 indicating no pain and 100 indicating the worst pain which was imaginable. A foul smelling purulent discharge, any change in colour of AM and surrounding erythema with local signs of inflammation were taken as suggestive of an infection. If the 3 layered gauze dressing was soaked, exudation was considered to be present.

Statistical analysis used:
Chisquare test and P value. The results were analyzed and conclusion were drawn.

Results

The clinical details of the cases which were studied have been shown in (Table/Fig 2) In total, 100 AM grafts were applied on 100 chronic lower limb ulcers. At the end of the 1st, 2nd and 3rd weeks, the test group (AM dressing) and the control group (normal saline dressing) were evaluated and compared. The parameters which were compared were epithelialization of the ulcer, percentages of granulation tissue, pain control, exudation and prevention of infection.

Epithelialisation:2
Out of 100 cases in the test group, 88 (88%) cases showed epithelialization by the end of the 3rd week as compared to 52 (52%) in control group (Table/Fig 3). Most of the cases, which showed complete epithelialization at the end of the 1st week were young with traumatic ulcers, without co-morbid conditions like diabetes. In 45 cases, complete epithelialization was observed at the end of the 2nd week. In this group, a majority of the ulcers were traumatic, ischaemic and venous ulcers with or without well controlled diabetes mellitus. In elderly patients and in cases with uncontrolled diabetes mellitus, the epithelialization was delayed.

Wound infection:
The AM prevented wound infections in 87% of the cases against 41% in the control group (Table/Fig 4).

Exudation:
By the end of the 1st week, the dressings were found to be dry in 69 (69%) cases in the test group as compared to 29% in the control group (Table/Fig 5).

Pain relief:
The pain score in the test group dropped from 70 to 10 in 3 week’s time. A maximal effect was observed in the first week (Table/Fig 6).

Granulation:
The %age of the granulation tissue increased significantly in the test group from 20% (mean) to 80% (mean) in 3 weeks as compared to the control group (Table/Fig 7), (Table/Fig 8),(Table/Fig 9),(Table/Fig 10). A maximal effect was observed in the first 2 weeks in the test group. It was healthy and vascular.

Discussion

Human amniotic membrane (AM ): The amnion is the inner most lining of the foetal membranes. It is made up of two membranes, the inner amniotic membrane and the outer chorion. The AM can be easily separated from the chorion. The AM is a thin but tough, smooth and transparent membrane. As a biological dressing, it has the following properties: • It provides secure coverage to the wound site, which reduces exudation from the wound.

A ntimicrobial property:
This property is believed to be due to the presence of antibodies in the AM and the impervious nature of the AM to micro-organisms (1). The high thrombin activity of the AM allows a very rapid and efficient attachment of the AM to the granulating surface (16). This close adherence eliminates the exposed status of the wound, which checks the bacterial count and allows restoration of the lymphatic integrity, which protects the circulating phagocytes from exposure and allows the removal of the surface debris and the bacteria (1), (3).
• The AM stimulates epithelialization from the ulcer bed and/or the wound edge, which is considered to be mediated by growth factors and progenitor cells which are released by it (15), (14). • One of the most striking effects, as was noted by Faulk et al and Burgos, is its granulation stimulating effect. This is due to some angiogenic and growth factors which are produced by the membrane (16), (7),(8),(9),(10). • Despite being a human derivative, it is not rejected, because the AM does not express the HLA A,B,C and the DR antigens, as was stated by Ward and Bennet in their study (7).

Pain Relief:
This is one of the well recognized properties of the AM when it is used as a skin substitute (17),(18),(14). This is possibly due to the diminished inflammation, the better state of hydration of the wound bed (19) and protection of the exposed nerve endings from external irritants. • Its other important properties are its anti-adhesive property ( it peels off on its own once the surface is epithelialized) and its scar reducing property (20). Various techniques and methods have been described for its preservation. We followed the glycerol preservation method, because of the ease of preservation and reconstitution, low cost and because of the anti bacterial and antiviral properties of glycerol. A glycerol preserved amnion is as effective as a fresh amnion (6). Another Indian study which used 85% glycerol for amnion preservation showed excellent results which were obtained with the use of this extremely economical dressing. This emphasizes the importance of establishing “amnion banks” in all hospitals, especially in the developing countries (6).

Method of use:
Before the membrane is applied, the wound should be prepared as it is prepared for skin grafting. A surgical scrub with antiseptic and minimal debridement is followed by moist compression until the oozing has stopped and the wound surface is reasonably dry. This procedure is preferably done in a clean, sterile dressing room,with observation of all the aseptic measures (16). The membrane is applied with its rough (chorionic) surface next to the wound (16). Care is taken to ensure that there is no trapping of air bubbles between the membrane and the wound by gently pressing it. The membrane is followed by a layer of anti-bacterial gauze (e.g. Soframycin tulle), some moist gauze, dry gauze, cotton and bandage.

Conclusion

We conclude that the amniotic membrane dressing is a safe, cheap and effective alternative method for treating non-healing leg ulcers, particularly in developing countries, where the cost of the dressing material is the major concern. As India is a developing country with a vast population and an exorbitant requirement of wound care resources, “amniotic membrane banks” at every hospital could be an answer!

Acknowledgement

We would like to thank all the consultant surgeons at the AJ Institute of Medical Sciences, Mangalore, for allowing us to analyze their cases. We thank Dr. Nanjesh for his help with the statistical analysis. The authors confirm that there are no known conflicts of interest which are associated with this publication and that there has been no financial support for this work that could have influenced its outcome.

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DOI and Others

DOI: JCDR/2012/4124:2069

Financial OR OTHER COMPETING INTERESTS:
None.


Date of Submission: Feb 09, 2012
Date of Peer Review: Mar 04, 2012
Date of Acceptance: Mar 22, 2012
Date of Publishing: May 01, 2012

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