Negative Pressure Wound Therapy for Split Thickness Skin Grafting to the Lower Leg After Excision of Skin Tumour: A Multicentre Randomised Study

Sponsor
Region Skane
Study ID
NCT07040683
Status
Recruiting
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Conditions

  • Bandages
  • Leg
  • Lower Extremity
  • Negative-Pressure Wound Therapy
  • Postoperative Complications
  • Skin Cancer
  • Skin Grafting
  • Skin Transplantation
  • Skin Tumour
  • Split Thickness Skin Graft
  • Surgical Wound Infection
  • Wound Healing

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Negative Pressure Wound Therapy (NPWT) — DEVICE
    Negative pressure wound therapy (NPWT) applied over the split-thickness skin graft on the lower leg after tumour excision. A protective silicone interface layer will be used, with continuous negative pressure of -125 mmHg applied until postoperative day 5, unless earlier change is clinically indicated.
  • Traditional Dressing — OTHER
    Traditional dressing applied over the split-thickness skin graft on the lower leg after tumour excision. The dressing consists of one or more layers of foam dressing applied on top, which may or may not be fixed with sutures according to surgeon preference, and an elastic bandage applied over the foam to provide gentle, even compression and immobilisation of the graft. The dressing will remain undisturbed until postoperative day 5 unless earlier change is clinically indicated.

Study Details

The goal of this clinical trial is to compare the effect of negative pressure wound therapy (NPWT) versus traditional dressings on the incidence of transplant infection in adult patients undergoing split-thickness skin grafting (STSG) to the lower leg following excision of a skin tumour. The main questions it aims to answer are: Does NPWT reduce the incidence of transplant infection within three months after STSG? Does NPWT improve secondary outcomes such as graft take, reduce reoperations, complications, and resource use? Researchers will compare patients treated with NPWT to patients treated with traditional dressings to see if NPWT results in lower infection rates and better clinical outcomes. Participants will: Undergo excision of a skin tumour on the lower leg followed by STSG. Be randomized to receive either NPWT or traditional dressings applied over the graft. Follow a structured postoperative care and mobilisation schedule. Attend follow-up visits at day 5 and day 14 postoperatively and be monitored through medical record review up to three months after surgery.

Key Dates

First listed
Jun 27, 2025
Start date
Nov 1, 2025
Status verified
Jun 2025
Primary completion
Dec 31, 2029
Completion
Mar 31, 2030

Study Design

Enrollment
242 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Negative Pressure Wound Therapy (NPWT)
    Participants in this arm will receive negative pressure wound therapy (NPWT) applied over the split-thickness skin graft after excision of a skin tumour on the lower leg. NPWT will be applied according to manufacturer instructions, using a protective interface layer and continuous negative pressure of -125 mmHg until postoperative day 5.
  • Active Comparator: Traditional Dressings
    Participants in this arm will receive traditional dressings applied over the split-thickness skin graft after excision of a skin tumour on the lower leg. The dressing will include a protective silicone interface layer and foam dressing with gentle compression, left undisturbed until postoperative day 5.

Primary Outcome Measure

Incidence of transplant infection within 3 months after index surgery [ Time Frame: From date of index surgery until 3 months postoperatively. ]

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