Scarring At Donor Sites After Split-Thickness Skin Graft.

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.

Completed

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Key information

Conditions

Donor Site Complication

Sex eligibility

All sexes

Study type

Observational

Primary location

The Burn Centre at Linköping University Hospital,

Linköping, 58185, Sweden

About this study

This is the third and last part of a clinical project concerning the treatment of split thickness skin graft donor sites. In the first part the Investigators completed a randomised clinical trial (RCT) in which donor sites were randomly assigned to treatment with either hydrofibre covered with film, non-adhesive polyurethane foam, or porcine xenograft. Results from the first study indicated that donor sites treated with hydrofibre and porcine xenograft healed significantly faster than those treated with polyurethane foam. As the hydrofibre was the most comfortable, easy to use, and cost-effective it was implemented as the standard of care for donor sites at the specific centre.

In the initial RCT, patients treated with polyurethane foam showed significantly longer healing times than the other treatment groups. As longer healing time has been shown to be a predictor for pathological donor site scarring it was hypothesised that this group would be the most unsatisfied with their scars, if they had any donor site scar at all eight years after their skin graft. In the second part of the project the long-term scar outcomes of the donor sites included in the RCT was investigated. Study participants were asked to evaluate their scars using the "Patients part" of the Patient and Observer Scar Scale (POSAS). After analysing the data collected in the second part, it was concluded that the fast and moist healing seen with hydrofibre seemed to result in significantly more satisfied patients - and members of the polyurethane foam group, as hypothesised, were significantly more unsatisfied with their donor site scars. The Investigators also found that the dressing associated with the fastest wound healing (the porcine xenograft) also had the poorest long-term outcome for scarring, according to the patients' opinion. This contradicts what is claimed to be the relation between duration of healing and donor site scarring.

In this last, third study, the aim was to investigate if the previous findings could be confirmed by an evaluation done by a blinded observer using POSAS. Donor sites were also evaluated for firmness and elasticity using the device; Cutometer dual MPA 580 (Courage and Khazaka Electronic GmbH, Cologne, Germany), which is described in the Method section.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

No former participation in the project

Treatment and study plan

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.

Other names: polyurethan foam, hydrofibre, film, porcone xenograft

Primary outcomes

donor sites scar outcome according to a blinded observer

Time frame: within 9 years after surgery

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.
donor sites scar outcome according to a cutometer

Time frame: within 9 years after surgery

measurement of elasticity and firmness with cutometer

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Official study title

Scarring At Donor Sites After Split-Thickness Skin Graft: A Prospective, Longitudinal, Randomised Trial; The Observer's View

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Jul 29, 2020
Registry last updated: Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed