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

NCT03971968 | Completed DMC

• 1 other identifier: CIP0019-201805-INT
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Burn; Scar; Face; Observational Study; Integra Artificial Skin

Outcome Measures

Primary Outcomes (1)

• POSAS Patient Scale Total Sum of Scores

  The POSAS Patient Scale contains six items (pain, itch, colour, thickness, pliability, texture) that are scored numerically on a ten-step scale from 1 (= healthy skin) to 10 (= worst imaginable scar). Together they make up the 'Total Sum of Scores'.

  at enrolment

Secondary Outcomes (8)

• POSAS Observer Scale Total Sum of Scores

  at enrolment

• Objective colour measurements with Mexameter

  at enrolment

• Objective thickness measurements with High Frequency Ultrasound

  at enrolment

• Objective elasticity measurements with Cutometer

  at enrolment

• Objective TEWL measurements with Tewameter

  at enrolment

Study Arms (2)

Group 1 = Intervention group

Group 1 suffered from third degree full thickness burns in the face/neck and received a surgical procedure with Integra Artificial Skin in the past

Procedure: Skin replacement with artificial skin

Group 2 = Control Group

Group 2 is the healthy skin of a comparable and/or contralateral skin-site of the face/neck

Interventions

Skin replacement with artificial skin PROCEDURE

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.

Also known as: Skin replacement with Integra Dermal Regeneration Template®

Group 1 = Intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population consists of human volunteers with third degree full thickness burn injuries in the face and/or neck, who underwent surgical treatment with IDRT.

You may qualify if:

• The subjects must be between 18 and 75 years old.
• Third degree full thickness burn injuries in the face and/or neck
• Having received surgical treatment with IDRT.
• Underwent surgery between 1998 and 2008.

You may not qualify if:

• Subjects with no matching control site comparable with assessed body location.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Organisation for Burns, Scar Aftercare and Research: collaborator

Study Sites (1)

Queen Astrid Military Hospital

Neder-Over-Heembeek, B-1120, Belgium

Location

MeSH Terms

Conditions

Cicatrix; Burns; Facies

Interventions

Skin, Artificial

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Disease Attributes

Intervention Hierarchy (Ancestors)

Artificial Organs; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: June 3, 2019
• Study Start: January 31, 2019
• Primary Completion: February 14, 2019
• Study Completion: February 14, 2019
• Last Updated: June 3, 2019

Record last verified: 2019-05

Locations

BE (1)