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

Not Applicable

Recruiting

• Conditions: Reconstruction
• Interventions: Procedure: thick STSG; thin STSG

• Registration Number: NCT05571904
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-05-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-10-06
• Study First Posted: 2022-10-07
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-13
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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.

Exclusion Criteria

1. Patients who were unable to complete the follow-up.
2. Pregnant or nursing mothers were not included.
3. Patients had an alternative source of pain other than surgical sites.
4. Patients with organ dysfunctions (heart failure, respiratory failure, liver dysfunction, renal impairment or intestinal failure), or cancers.
5. Patients with autoimmune diseases (rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, Sjogren's syndrome, connective tissues disease or systemic vasculitis) were not included.
6. Patients who had medications (such as corticosteroids, immunosuppressive agents or chemotherapy) within six months were not included.
7. Other reasons.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the thin STSG group	thick STSG; thin STSG	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 thick STSG group	thick STSG; thin STSG	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).

Primary Outcome Measures

Name	Time	Method
healing time of the donor sites	2 months post surgery	The complete healing time of the donor sites was defined as the day when 100% epithelialization was achieved,

Secondary Outcome Measures

Name	Time	Method
pains scores (Visual Analogue Scales)	on Day 1 and Day 7 postoperatively	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.
pruritus scores	at 3 months and at 6 months post-surgery	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.
scars scores ( Vancouver Scar Scales )	at 3 months and 6 months post-surgery	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.
life quality (36-item short form health survey scores)	Prior to surgery or at 6 months post-surgery	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.

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China