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

Summary

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.

Conditions

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

Interventions

DEVICE

Negative Pressure Wound Therapy (NPWT)

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.

OTHER

Traditional Dressing

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.

Sponsors & Collaborators

• Region Skane

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-01

Primary Completion

2027-12-31

Completion

2028-03-31

Countries

• Sweden

Study Locations