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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

ConditionsSkin TransplantationSkin GraftingSplit Thickness Skin GraftNegative-Pressure Wound TherapyPostoperative ComplicationsSurgical Wound InfectionLower ExtremitySkin CancerSkin TumourWound HealingBandagesLeg
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Inability to follow postoperative instructions due to cognitive impairment, dementia, or significant language barriers

Inability to provide informed consent

Ongoing sepsis

Advanced heart failure

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

232 Participants
are divided into 2 treatment groups
Group A: Negative Pressure Wound Therapy (NPWT)Experimental treatment 1 intervention
Group B: Traditional DressingsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of transplant infection within 2 weeks after index surgery

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.

Time frame
From date of index surgery until 2 weeks postoperatively.

Secondary outcomes

1

Graft loss percentage graft take at 2 weeks

Graft loss percentage graft at 2 weeks after index surgery.

Time frame
From date of index surgery until 2 weeks postoperatively.
2

Reoperation within 2 weeks after index surgery

Proportion of participants requiring reoperation related to the graft site within 2 weeks after index surgery.

Time frame
From date of index surgery until 2 weeks postoperatively.
3

Bleeding within 2 weeks after index surgery

Incidence of clinically significant bleeding at the graft site requiring medical intervention within 2 weeks after index surgery.

Time frame
From date of index surgery until 2 weeks postoperatively.
4

Complications within 3 months after index surgery

All systemic and surgical complications occurring within 3 months after the index surgery will be recorded and graded according to the Clavien-Dindo classification.

Time frame
From date of index surgery until 3 months postoperatively.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Skane

Lead sponsor

Source ClinicalTrials.gov
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