Donor Site Complication Clinical Trial
Official title:
Scarring At Donor Sites After Split-Thickness Skin Graft: A Prospective, Longitudinal, Randomised Trial; The Observer's View
NCT number | NCT04490213 |
Other study ID # | 2018/212-31 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 15, 2018 |
Est. completion date | March 1, 2019 |
Verified date | July 2020 |
Source | University Hospital, Linkoeping |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 17 |
Est. completion date | March 1, 2019 |
Est. primary completion date | March 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: Participation in part I (RCT) and part II of the project Exclusion Criteria: No former participation in the project |
Country | Name | City | State |
---|---|---|---|
Sweden | The Burn Centre at Linköping University Hospital, | Linköping |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Linkoeping |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | donor sites scar outcome according to a cutometer | measurement of elasticity and firmness with cutometer | within 9 years after surgery |
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