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A randomized trial study on the effect of amniotic membrane graft on wound healing process after anal fistulotomy

Ensaio clínico randomizado sobre o efeito do enxerto de membrana amniótica sobre o processo de cicatrização após fistulotomia anal

Abstract

Objective

Human amniotic membrane (HAM) used as a wound coverage for more than a century. The aim of this study is to evaluate the efficacy of amniotic membrane on wound healing and reduce post-operative complication.

Study design

Randomized clinical trial study.

Place and duration of study

Surgery Department, Shahid Faghihi Hospital, Shiraz, in the period of between Sep. 2014 and Nov. 2015.

Methodology

73 patients with anal fistula were divided into two groups. The patients suffered from simple perianal fistula (low type) without any past medical history. Fistulotomy were performed for all of them and in interventional group HAM were applied as biologic dressing. Their wound healing improvement was evaluated post-operative in two groups.

Results

From 73 patients participated in the study, 36 patients were in control group and 37 patients were in intervention group. According to the analysis of images taken from the wound, the rate of wound healing was 67.39% in intervention group and 54.51% in control group (p < 0.001). Discharge, pain, itching and stool incontinency was lower in intervention group. Analysis of pathology samples taken from the wound showed no differences between two groups.

Conclusion

HAM application could lead to improvement of wound healing and reduced post-operative complications. In conclusion, HAM may act as a biologic dressing in the patients with anal fistula.

Keywords
Anal fistula; Human amniotic membrane; Wound healing; Post-operative complication

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