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

NCT05571904 | Unknown

• 1 other identifier: KY20220701-08
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Reconstruction

Keywords

donor site; thick split-thickness skin graft; thin split-thickness skin graft; reconstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• life quality (36-item short form health survey scores)

  Prior to surgery or at 6 months post-surgery

• pains scores (Visual Analogue Scales)

  on Day 1 and Day 7 postoperatively

• pruritus scores

  at 3 months and at 6 months post-surgery

• scars scores ( Vancouver Scar Scales )

  at 3 months and 6 months post-surgery

Study Arms (2)

the thick STSG group

EXPERIMENTAL

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

the thin STSG group

ACTIVE COMPARATOR

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

Interventions

thick STSG; thin STSG PROCEDURE

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.

the thick STSG group; the thin STSG group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients had skin defects at functional sites or joint sites.
• Patients aged 20-80 years.
• The lateral thighs were chosen as the donor sites.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (1)

• Bian Y, Sun C, Zhang X, Li Y, Li W, Lv X, Li J, Jiang L, Li J, Feng J, Li XY. Wound-healing improvement by resurfacing split-thickness skin donor sites with thin split-thickness grafting. Burns. 2016 Feb;42(1):123-130. doi: 10.1016/j.burns.2015.07.008. Epub 2015 Nov 23.

  PMID: 26615713 BACKGROUND

Related Links

• Pubmed

Study Officials

• Rong Wu, phD

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Yin Wu, phD

CONTACT

18305155832; medwuyin@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending doctor of Department of Burn and Plastic Surgery,Nanjing First Hospital

Model Details: (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.

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 7, 2022
• Study Start: May 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 10, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: December,31,2023
• Access Criteria: no limits

Locations

CN (1)