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

N

Nanjing Medical University

Status

Enrolling

Conditions

Reconstruction

Treatments

Procedure: thick STSG; thin STSG

Study type

Interventional

Funder types

Other

Identifiers

NCT05571904
KY20220701-08

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

the thick STSG group
Experimental group
Description:
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).
Treatment:
Procedure: thick STSG; thin STSG
the thin STSG group
Active Comparator group
Description:
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.
Treatment:
Procedure: thick STSG; thin STSG

Trial contacts and locations

1

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Central trial contact

Yin Wu, phD

Data sourced from clinicaltrials.gov

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