Observational Study for the Long-Term Effects of a Dermal Substitute on Patients With Facial Burns.

CompletedOBSERVATIONAL
Enrollment

8

Participants

Timeline

Start Date

January 31, 2019

Primary Completion Date

February 14, 2019

Study Completion Date

February 14, 2019

Conditions
Cicatrix
Interventions
PROCEDURE

Skin replacement with artificial skin

Integra® Dermal Regeneration Template is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and glycosaminoglycan (chondroitin-6-sulfate). The epidermal substitute layer is made of thin polysiloxane (silicone) layer to control moisture loss from the wound. The silicone outer layer temporarily closes the wound to ward off infection and control fluid and heat loss. As skin cells migrate into the matrix the collagen is slowly absorbed into the body and replaced with protein that is naturally produced by the skin. In approximately 14 to 21 days, new dermal skin is produced and the silicone layer can be removed. A thin skin graft of the person's epidermis is applied to the wound area to complete the procedure. In total, the two surgical procedures are typically completed within 30 days. A person is left with flexible growing skin and minimal damage at the skin graft donor sites.

Trial Locations (1)

B-1120

Queen Astrid Military Hospital, Neder-Over-Heembeek

All Listed Sponsors
collaborator

Organisation for Burns, Scar Aftercare and Research

OTHER

lead

Universitair Ziekenhuis Brussel

OTHER

NCT03971968 - Observational Study for the Long-Term Effects of a Dermal Substitute on Patients With Facial Burns. | Biotech Hunter | Biotech Hunter