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
AJ Institute of Medical Sciences, Department of Surgery,
Mangalore, India - 575004.
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.
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