Lower Extremity Graft Study (LEGS): A Multicentre Randomised Controlled Trial of Negative Pressure Wound Therapy Versus Conventional Dressings for Split-thickness Skin Grafts After Lower Leg Skin Tumour Excision

NCT07040683 · tracked via the Priya Life Science Sweden tracker

Sponsor

Region Skane

Phase

Not applicable

Started

2025-11-01

Last updated

2026-09-02

Condition(s) studied

Skin TransplantationSkin GraftingSplit Thickness Skin GraftNegative-Pressure Wound TherapyPostoperative ComplicationsSurgical Wound InfectionLower ExtremitySkin CancerSkin TumourWound HealingBandagesLeg

Investigational drug(s) / intervention(s)

Negative Pressure Wound Therapy (NPWT)Traditional Dressing

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.

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.

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 graft infection within 2 weeks 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Adults aged 18 years or older * Undergoing excision of a skin tumour on the lower leg with planned coverage using split-thickness skin grafting (STSG) * Eligible procedures include primary excision, secondary excision, or extended excision performed at the same site as a previous tumour surgery * Ability to provide written informed consent * Ability to comply with postoperative instructions and follow-up visits Exclusion Criteria: * Inability to follow postoperative instructions due to cognitive impairment, dementia, or significant language barriers * Inability to provide informed consent * Severe systemic illness, including: * Ongoing sepsis * Advanced heart failure * End-stage renal or liver disease * Active chemotherapy within the previous three months * Ongoing treatment with immunosuppressive medications, including: * Systemic corticosteroids (e.g., prednisone \>20 mg/day or equivalent) * Calcineurin inhibitors (e.g., cyclosporine, tacrolimus) * Antimetabolites (e.g., methotrexate, azathioprine, mycophenolate mofetil) * mTOR inhibitors (e.g., sirolimus, everolimus) * Biologic therapies (e.g., rituximab, TNF inhibitors, IL-6 inhibitors, IL-1, IL-17, IL-23 inhibitors) * Targeted molecular therapies (e.g., JAK inhibitors such as tofacitinib, baricitinib) * Other immunosuppressive drugs * Previous radiation therapy to the surgical site * Presence of severe skin disease affecting the planned graft recipient site (e.g., advanced psoriasis)

Primary outcome measure(s)

Incidence of transplant infection within 2 weeks after index surgery — From date of index surgery until 2 weeks postoperatively.
Graft infection defined as clinical infection of the skin graft diagnosed by a physician or confirmed by microbiological culture, occurring within 2 weeks after initial tumor excision and split-thickness skin grafting to the lower leg.

Trial sites (1)

Facility	City	Region	Status
Dept. of Plastic and Reconstructive Surgery and Dept. of Health Sciences, Skåne University Hospital, Malmö, Sweden.	Malmö	Sweden	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07040683 on ClinicalTrials.gov ↗ ← All trials in Sweden