Scarring At Donor Sites After Split-Thickness Skin Graft.

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04490213
Study type	Observational
Source	University Hospital, Linkoeping
Contact
Status	Completed
Phase
Start date	June 15, 2018
Completion date	March 1, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03663036` - Arthroscopic Superior Capsular Reconstruction With Fascia Lata Autograft - Survivorship of the Autograft Analysis	N/A
Completed	`NCT01670201` - An Investigation to Evaluate a New Donor Site Dressing in Surgical Burn Patients	N/A
Completed	`NCT04422925` - s100β, NSE n GFAP in Living Donor Hepatectomy and Delirium
Recruiting	`NCT06030791` - BTB Graft Harvest and Donor Site Morbidity After ACL Reconstruction
Completed	`NCT04050124` - Impact of Prisma on Donor Site Pain	N/A
Not yet recruiting	`NCT04997863` - Clinical Efficacy and Safety of Sericin Hydrogel Sheet Impregnated With Bird's Nest Extract	N/A
Not yet recruiting	`NCT03850119` - Nanofat on Wound Healing and Scar Formation	N/A
Completed	`NCT02737748` - TWB-103 for Adult Patients With Split-Thickness Skin Graft Donor Site Wounds	Phase 1/Phase 2
Terminated	`NCT03992820` - Transcutaneous Electrical Nerve Stimulation for Local Anaesthesia	N/A
Completed	`NCT04403503` - The Influence of Tissue Adhesive to Palatal Donor Site Healing.	N/A
Completed	`NCT03209167` - Comparing Patient Satisfaction of the Abdomen After DIEAP Procedure and Conventional Abdominoplasty	N/A
Recruiting	`NCT04743375` - Clinical Efficacy of Silk Sericin Dressing With Collagen for Split-thickness Skin Graft Donor Site Treatment	N/A
Recruiting	`NCT05740033` - Radial Forearm Donor Site Closure	N/A
Recruiting	`NCT04186273` - Clinical Safety and Scar Prevention Study of a Topical Antifibrotic Compound FS2.	Phase 2
Completed	`NCT04692961` - Change in the Lower Leg Muscle Stiffness Following Peroneal Artery-based Flap	N/A
Completed	`NCT06044519` - A Single Center Trial of Donor Site Wound Dressings After Split Thickness Skin Grafting.	Phase 4
Completed	`NCT04867070` - Pain Management in Laparoscopic Living-donor Nephrectomy: The Impact of Erector Spinae Plane Block (ESPB) on Perioperative Period	N/A
Terminated	`NCT02671344` - Determining the Genetic Profile in Semen Donors With Pregnancy, Donor Versus no Pregnancy Obtained in TRA

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.