Abstract

Introduction: Amniotic membrane (AM), the most internal placental membrane, has unique properties including anti adhesive effects, bacteriostatic, wound protection and pain-reduction properties, as well as epithelialization initialization capacities. AM is widely available and less costly than other bioengineered skin substitutes. In a prospective study, we evaluated the safety, feasibility, and the effects on healing of AM graft in patients with chronic leg ulcers.

Material and methods: Amnion grafts were prepared from placentas harvested during cesarean section or normal delivery. 82 patients with leg ulcers randomly divided into two groups formed material for the study. In group I (study group n=42) the ulcers were covered with amnion graft and held in place with a secondary dressing. It was opened on 7th day. Group II (control group n=40) the ulcers were treated with EUSOL dressings daily for 7 days. Size of the ulcer, assessment of pain and epithelialization were assessed on 7th day and 15th day and at follow-up after 3 months.

Results: All grafted AM had adhered to the wound bed 7 days after being applied with a 100% engraftment rate. The percentage of granulation tissue increased significantly (from 18% on day 0 to 70% on day 15, p<0.0001), along with a significant decrease of fibrinous slough (from 35% at day 0 to 14% at day 15, p<0.001). A significant clinical response occurred in 28 patients (66.6%) including complete healing (20%) in three during the 3-month follow-up period. The ulcer surface area decreased significantly from a mean value (+/- standard deviation) of 4.29 +/- 2.39 cm2 at baseline to 2.81+/-2.02 cm2 on day 30 (p<0.001). All patients experienced a significant reduction of ulcer related pain rapidly after AM transplantation. No adverse events were recorded.

Conclusion: AM transplantation seems to function as a safe substrate, promoting proper epithelialization while suppressing excessive fibrosis. Advantages of biotherapy with AM are its easy availability and low-cost production, and that it can be applied as an ambulatory treatment without immobilization. AM transplantation may be considered as an alternative method for treating chronic leg ulcers.

Key words: Amniotic membrane, chronic ulcers, wound healing