Amnion for Burn Wounds – Human Amniotic Membranes as a Biological Dressing in the Treatment of Burns

Zusammenfassung der Studie

Upon admission, all patients meeting the criteria for participation are examined. If you participate, two wound areas of 7x7 cm are selected and then randomly covered once with amniotic membrane, while the other (for comparison) is covered with cadaver skin. Which wound area is covered with which material is decided completely at random – like flipping a coin. Then, the amniotic membrane or cadaver skin is applied to the now open wounds and covered with an additional dressing (this corresponds to the first visit). This is done in our burn unit and is performed by one of our burn specialists. After a few days (3-14 days, depending on wound conditions), an autologous skin transplantation takes place (this corresponds to the second study visit). This autologous skin transplantation is part of the standard therapy in our burn unit. Subsequent study visits 3 and 4 correspond to a dressing change and take place 4-6 and 12-14 days after the autologous skin transplantation, respectively. During these visits, the results are documented photographically. The dressing change will also be performed by a physician from our clinic. Finally, after 3 months, a follow-up visit takes place in our outpatient clinic, which is the fifth and final visit. This is also structured similarly to the third and fourth visits and will be documented photographically. The primary focus of the study is to investigate how well the transplanted autologous skin integrates into the burned area. Additionally, the progress in the healing of the patient's wound is assessed, the time taken for the wound to heal completely, scar formation, and the quality of the scar.

(BASEC)

Untersuchte Intervention

The use of amniotic membranes in the treatment of burn wounds is already an approved and established therapy according to international standards. In Switzerland, this is the first application for burn wounds. These amniotic membranes are obtained during a cesarean section, specially processed, and then deep-frozen. In our study, these amniotic membranes are applied as a temporary dressing to the burned areas after the removal of dead skin cells due to the burn. The cells of these membranes have various properties that can be beneficial for wound healing. Among other things, they cause a lower reaction of the body against foreign material and promote wound healing. Due to their special properties, such dressings also show fewer wound infections, less pronounced scar formation, and an overall shorter healing time, accompanied by less pain. Amniotic membranes are already used today in the treatment of various eye conditions and are already recognized as a therapy in Switzerland in this context. The aim of this study is to establish this use of amniotic membranes in the treatment of burn wounds as an alternative dressing.

(BASEC)

Untersuchte Krankheit(en)

In our study, we investigate burn wounds in adult patients treated at the Burn Center of the University Hospital Zurich. In the treatment of burns, allogeneic skin grafts (usually cadaver skin donations) are currently used for the temporary coverage of burn wounds. This allows the recovery of the wound bed until healing is complete or definitive coverage with autologous skin is possible. In our research project, we aim to demonstrate that the use of specially processed material from the innermost layer of the amniotic sac, called amniotic membrane, represents a safe alternative for the temporary coverage of burn wounds, which can provide better results in terms of wound healing and scar formation compared to cadaver skin donations.

(BASEC)

Sponsor

Kim, Bong-Sung, MBA Prof. Dr. med. Department of Plastic Surgery and Hand Surgery University Hospital Zurich Rämistrasse 100 CH 8091 Zurich Phone: +41 44 255 33 39 Mail: bong-sung.kim@usz.ch

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Zürich

(BASEC)

Datum der Bewilligung durch die Ethikkommission

12.05.2023

(BASEC)

Ergebnisse der Studie