Scarring At Donor Sites After Split-Thickness Skin Graft.

NCT04490213 | Completed

• 1 other identifier: 2018/212-31
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to investigate if previous findings on the association between dressing treatments and subjective opinion on final donor site scar outcome using the patient scale of POSAS could be confirmed objectively. Scar outcome measurements were assessed by a blinded observer using POSAS and the device: Cutometer dual MPA 580 (Courage and Khazaka Electronic GmbH, Cologne, Germany) to measure the viscoelasticity of the skin.

Conditions

Donor Site Complication

Outcome Measures

Primary Outcomes (2)

• donor sites scar outcome according to a blinded observer

  evaluated with the scar scale Patient and Observer Scar Assesment Scale (POSAS). The scale contains six items that are scored numerically and when added, constitutes the "Total Score" of the Patient or the Observer Scale. Each of the six items on both scales has a 10-point range (1 - 10), with 10 indicating the worst imaginable scar or sensation. The lowest score, "1" corresponds to the normal skin.

  within 9 years after surgery

• donor sites scar outcome according to a cutometer

  measurement of elasticity and firmness with cutometer

  within 9 years after surgery

Study Arms (3)

hydrofibre, Aquacel

Study participants were previously treated on their donor sites with these CE-marked dressing products (RCT study published in 2014) and are now compared regarding scar outcome at the donor sites

Other: Allevyn, Aquacel and Tegaderm, Mediskin

polyurethane foam, Allevyn

Study participants were previolsuy treated on their donor sites with these CE-marked dressing products (RCT study published in 2014) and are now compared regarding scar outcome at the donor sites

Other: Allevyn, Aquacel and Tegaderm, Mediskin

porcine xenograft, Mediskin

Study participants were previolsuy treated on their donor sites with these CE-marked dressing products (RCT study published in 2014) and are now compared regarding scar outcome at the donor sites

Other: Allevyn, Aquacel and Tegaderm, Mediskin

Interventions

Allevyn, Aquacel and Tegaderm, Mediskin OTHER

Wound dressing tested earlier on donor sites, in this study scar outcome between the 3 dressing groups are compared.

Also known as: polyurethan foam, hydrofibre, film, porcone xenograft

hydrofibre, Aquacel; polyurethane foam, Allevyn; porcine xenograft, Mediskin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Of the 27 participants in the second part of the study, two had died, six (with a total of 8 donor sites) chose not to participate and two did not answer our letter. The remaining 17 were included in the Observer follow up. Of the 17 participants, five came from the hydrofibre group, six from the polyurethane foam, and six from porcine xenograft group.

You may qualify if:

• Participation in part I (RCT) and part II of the project

You may not qualify if:

• No former participation in the project

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Study Sites (1)

The Burn Centre at Linköping University Hospital,

Linköping, 58185, Sweden

Location

MeSH Terms

Interventions

allevyn; Carboxymethylcellulose Sodium; Motion Pictures

Intervention Hierarchy (Ancestors)

Methylcellulose; Cellulose; Glucans; Polysaccharides; Carbohydrates; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: July 29, 2020
• Study Start: June 15, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)