NCT03971968|CompletedDMC
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Sponsor study identifier
observational
8
1 country
1
Study Start
January 31, 2019
Actual (reported)Primary Completion
February 14, 2019
Actual (reported)Study Completion
February 14, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 14, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 31, 2019
Actual (reported)February 14, 2019
Actual (reported)February 14, 2019
Actual (reported)May 23, 2019
Actual (reported)June 3, 2019
Actual (reported)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
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
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
Group 2 is the healthy skin of a comparable and/or contralateral skin-site of the face/neck
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Queen Astrid Military Hospital
Neder-Over-Heembeek, B-1120, Belgium
8 participants (actual enrollment reported by the registry).
First Submitted
May 23, 2019
First Posted
June 3, 2019
Study Start
January 31, 2019
Actual (reported)Effect of PDRN in Post-operative Scars
Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract
Contact the study team to confirm eligibility.
Primary Completion
February 14, 2019
Actual (reported)Study Completion
February 14, 2019
Actual (reported)Last Updated
June 3, 2019
Record last verified: 2019-05
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Source: ClinicalTrials.gov.
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