- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01974583
Wound-healing Improvement by Resurfacing Split-Thickness Skin Donor Sites With Thin Split-thickness Grafting
Study Overview
Status
Detailed Description
Background:Split-thickness skin grafting remains fundamental treatment of patients with deep burns and other traumatic injuries. However, the split-thickness skin graft (STSG) donor site dressing has been controversial until now. Our study here aimed to assess patient comfort and wound-healing efficacy with the application of thin split-thickness grafting on STSG donor sites.
Methods: 192 consecutive patients undergoing split-thickness skin grafting were included in the study and the participants were randomly divided into three groups: Group A was regrafted with thin STSG, while, Group B and Group C were covered with the occlusive hydrocellular dressing and paraffin gauze, respectively. The three groups were compared regarding to the time of epithelialization, pain sensed by the patients and the scar formation.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients who continuously received an STSG from January 2002 to December 2010 in Department of Burn and Plastic Surgery, Tangdu Hospital, Fourth Military Medical University
Exclusion Criteria:
- The patients who were significant psychiatric, hypersensitive to silver, and not be followed up were excluded
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
the treatment group A
The people in treatment group were regrafted with thin split-thickness skin graft
|
Group A (the treatment group) were regrafted with thin split-thickness skin graft
|
|
the control group B
The group B covered with the occlusive hydrocellular dressing (Allevyn Adhesive, Smith & Nephew)
|
group B covered with the occlusive hydrocellular dressing (Allevyn Adhesive, Smith & Nephew)
|
|
the control group C
Group C were covered with paraffin gauze
|
Group C covered with paraffin gauze
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The time of epithelialization
Time Frame: up to 4 weeks
|
The time of epithelialization was observed every 3 days
|
up to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain sensed by the patients
Time Frame: up to 6 months
|
Pain sensed by the patients was assessed by Wong-Baker FACES Pain Rating Scale on day 2 and 5 after surgery
|
up to 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Scar formation of skin donor site
Time Frame: 1 year
|
Scar formation of skin donor sites was evaluated by Vancouver scar scale in terms of colour, vascular distribution, thickness and scratchability 6-12 months after surgery
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yongqian Bian, doctor, specify unaffiliated
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TDLL-2030130
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
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-
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Clinical Trials on regrafted with thin split-thickness skin graft
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Markman Biologics CorporationUnknown
-
Indonesia UniversityRecruitingBurn Degree Second | Burn Degree ThirdIndonesia
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Avita MedicalUnited States Department of Defense; Royal Perth Hospital; MedDRA Assistance Inc and other collaboratorsCompleted
-
First Affiliated Hospital, Sun Yat-Sen UniversityRecruiting
-
LifeBridge HealthKinetic Concepts, Inc.WithdrawnWounds and InjuriesUnited States
-
CUTISS AGUniversity of Zurich; University Hospital, Zürich; Julius Clinical; Sintesi Research... and other collaboratorsActive, not recruitingBurnsSwitzerland, Italy, Netherlands
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CUTISS AGUniversity of Zurich; University Hospital, Zürich; Julius Clinical; Sintesi Research... and other collaboratorsActive, not recruitingBurnsSwitzerland, Netherlands, Italy
-
CUTISS AGUniversity of Zurich; University Hospital, Zürich; Julius Clinical; Sintesi Research... and other collaboratorsActive, not recruitingSkin WoundSwitzerland, Italy, Netherlands
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Shaheed Mohtarma Benazir Bhutto Institue of TraumaNot yet recruiting
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Coordinación de Investigación en Salud, MexicoUnknownBurns | Skin UlcerMexico