Clinical trial NCT04490213: Scarring At Donor Sites After Split-Thickness Skin Graft.
Official title: Scarring At Donor Sites After Split-Thickness Skin Graft: A Prospective, Longitudinal, Randomised Trial; The Observer's View
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Donor Site Complication
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

No former participation in the project

Primary outcomes:
measure: donor sites scar outcome according to a blinded observer
timeFrame: within 9 years after surgery
measure: donor sites scar outcome according to a cutometer
timeFrame: within 9 years after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: The Burn Centre at Linköping University Hospital,
Study officials:
References: