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

NCT ID: NCT05571904

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2022-12-10

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.

Conditions

Reconstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

the thick STSG group

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).

Group Type: EXPERIMENTAL

thick STSG; thin STSG

Intervention Type: 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 thin STSG group

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.

Group Type: ACTIVE_COMPARATOR

thick STSG; thin STSG

Intervention Type: 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.

Interventions

thick STSG; thin STSG

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

YinWu

attending doctor of Department of Burn and Plastic Surgery,Nanjing First Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rong Wu, phD

Role: STUDY_DIRECTOR

The First Affiliated Hospital with Nanjing Medical University

Locations

Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yin Wu, phD

Role: CONTACT

medwuyin@163.com

18305155832

Facility Contacts

Yin Wu, phD

Role: primary

medwuyin@163.com

18305155832

Chao Hao, MD

Role: backup

haochao@163.com

15905166117

References

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.

Reference Type: BACKGROUND

PMID: 26615713 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/26615713/

Pubmed

Other Identifiers

KY20220701-08

Identifier Type: -

Identifier Source: org_study_id