The Comparison of Thick Split-thickness Skin Graft Versus Thin Split-thickness Skin Graft

Study Overview
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Brief Summary
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In clinical settings, split-thickness skin graft (STSG) remain the gold standard for covering large skin defects. However, STSGs usually bring complications to the donor sites. The study objective was to compare the efficacy of thick split-thickness skin graft versus thin split-thickness skin graft in the reconstruction of the donor site.

Detailed Description
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All patients were randomly divided into two groups. For the patients in the thick STSG group, the surgeons harvested thick STSGs which were larger than recipient sites. The extra skin was punctured and stretched to cover the donor site (the novel technique). For the patients in the thin STSG group, the surgeons harvested thick STSGs of the size of recipient sites. Their donor sites were covered with thin STSGs which were harvested from other parts of the patients. The 36-item short form health survey (SF-36) scores, pain scores, pruritus scores, scar scores and rates of complications were compared between the two groups.

Official Title
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The Comparison of Thick Split-thickness Skin Graft Versus Thin Split-thickness Skin Graft in the Reconstruction of the Donor Site

Conditions
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Reconstruction

Intervention / Treatment
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* Procedure: thick STSG; thin STSG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients had skin defects at functional sites or joint sites. Patients aged 20-80 years. The lateral thighs were chosen as the donor sites. Exclusion Criteria: Patients who were unable to complete the follow-up. Pregnant or nursing mothers were not included. Patients had an alternative source of pain other than surgical sites. Patients with organ dysfunctions (heart failure, respiratory failure, liver dysfunction, renal impairment or intestinal failure), or cancers. Patients with autoimmune diseases (rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, Sjogren's syndrome, connective tissues disease or systemic vasculitis) were not included. Patients who had medications (such as corticosteroids, immunosuppressive agents or chemotherapy) within six months were not included. Other reasons.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: (1) Patients had skin defects at functional sites or joint sites; (2) Patients aged 20-80 years; (3) The lateral thighs were chosen as the donor sites.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the thick STSG group<br>For the patients in the thick STSG group, the surgeons harvested thick STSGs which were larger than recipient sites. The extra skin was punctured and stretched to cover the donor site (the novel technique). | Procedure: thick STSG; thin STSG<br>* For all the patients, thick STSGs (at a depth of 0.7 mm) were harvested from the upper lateral thighs to repair skin defects at functional sites or joint sites. For patients in the thick STSG group, the surgeons harvested a larger size of thick STSGs than the size of recipient sites. The size of the donor site was 150% - 200% of the size of the recipient site. Part of the thick STSG was grafted onto the recipient site. Subsequently, the leftover skin was punctured (in 1.5:1 mesh ratio) and stretched to obtain expansion. The donor site was covered by the leftover skin completely. In other words, the donor site was reconstructed by resurfacing the large sheet of thick STSG in situ. For patients in the thin STSG group, the surgeons harvested thick STSGs of the size of recipient sites. Their donor sites were covered with a large sheet of thin STSGs (at a depth of 0.4 mm) which were harvested from other parts of the patients.<br>|
| Active Comparator: the thin STSG group<br>For the patients in the thin STSG group, the surgeons harvested thick STSGs of the size of recipient sites. Their donor sites were covered with thin STSGs which were harvested from other parts of the patients. | Procedure: thick STSG; thin STSG<br>* For all the patients, thick STSGs (at a depth of 0.7 mm) were harvested from the upper lateral thighs to repair skin defects at functional sites or joint sites. For patients in the thick STSG group, the surgeons harvested a larger size of thick STSGs than the size of recipient sites. The size of the donor site was 150% - 200% of the size of the recipient site. Part of the thick STSG was grafted onto the recipient site. Subsequently, the leftover skin was punctured (in 1.5:1 mesh ratio) and stretched to obtain expansion. The donor site was covered by the leftover skin completely. In other words, the donor site was reconstructed by resurfacing the large sheet of thick STSG in situ. For patients in the thin STSG group, the surgeons harvested thick STSGs of the size of recipient sites. Their donor sites were covered with a large sheet of thin STSGs (at a depth of 0.4 mm) which were harvested from other parts of the patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| healing time of the donor sites | The complete healing time of the donor sites was defined as the day when 100% epithelialization was achieved, | 2 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| life quality (36-item short form health survey scores) | The life quality of patients was evaluated by the 36-item short form health survey (SF-36) scores (including General Health scores, Mental Health scores, Social Function scores, and Vitality scores). The minimum value is 0. The maximum value is 100. The higher score means a better outcome. | Prior to surgery or at 6 months post-surgery | 
| pains scores (Visual Analogue Scales) | The degrees of pain at the donor sites were evaluated by the Visual Analogue Scales. Patients were asked to score levels of pain (0 = no pain, 5 = worst pain) using Visual Analogue Scales. The higher score means a worse outcome. | on Day 1 and Day 7 postoperatively | 
| pruritus scores | The degrees of pruritus at the donor sites were measured by scores (1 = never or occasional itches, 2 = itches do not disturb sleep, 3= itches disturb sleep). The higher score means a worse outcome. | at 3 months and at 6 months post-surgery | 
| scars scores ( Vancouver Scar Scales ) | The scar formation at the donor sites were evaluated with the Vancouver Scar Scales (from 0 to 15, 0 = best and 15 = worst) in terms of pigmentation, vascularity, pliability and height. The higher score means a worse outcome. | at 3 months and 6 months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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donor site, thick split-thickness skin graft, thin split-thickness skin graft, reconstruction