Scarring At Donor Sites After Split-Thickness Skin Graft.

NCT ID: NCT04490213

Last Updated: 2020-07-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-15
• Study Completion Date: 2019-03-01

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.

Detailed Description

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.

Conditions

Donor Site Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Allevyn, Aquacel and Tegaderm, Mediskin

Intervention Type: OTHER

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

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

Allevyn, Aquacel and Tegaderm, Mediskin

Intervention Type: OTHER

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

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

Allevyn, Aquacel and Tegaderm, Mediskin

Intervention Type: OTHER

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

Interventions

Allevyn, Aquacel and Tegaderm, Mediskin

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

Intervention Type: OTHER

Other Intervention Names

polyurethan foam, hydrofibre, film, porcone xenograft

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

No former participation in the project

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Linkoeping

OTHER

Sponsor Role: lead

Responsible Party

Folke Sjoberg

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Burn Centre at Linköping University Hospital,

Linköping, , Sweden

Countries

Sweden

Other Identifiers

2018/212-31

Identifier Type: -

Identifier Source: org_study_id