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

NCT03971968 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2019-06-03

No results posted yet for this study

Summary

The aim of this observational study is to investigate the long-term (between 10-20 years) results for the surgical treatment of third degree burn injury in the face and/or the neck by means of Integra® Dermal Regeneration Template.

This study is an observational case-control study. The healthy skin of a comparable and/or contralateral skin-site of the face/neck serves as a comparator.

The population consists of human volunteers between 18 and 75 years old with third degree full thickness burn injuries in the face and/or neck, who underwent surgical treatment with IDRT between 1998 and 2008.

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.

Sponsors & Collaborators

  • Organisation for Burns, Scar Aftercare and Research

    collaborator OTHER

  • Universitair Ziekenhuis Brussel

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-31
Primary Completion
2019-02-14
Completion
2019-02-14

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03971968 on ClinicalTrials.gov