An interventional study of Negative Pressure Wound Therapy (NPWT) and Traditional Dressing in Skin Transplantation, Skin Grafting and Split Thickness Skin Graft, sponsored by Region Skane. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Region Skane · Not applicable, Interventional, and Treatment
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.
Split-thickness skin grafting (STSG) to the lower leg is a common surgical procedure performed after excision of skin tumours, particularly when primary closure is not feasible. Although the technique is well established, postoperative infections and graft-related complications remain a clinical challenge, especially in lower leg wounds, which are prone to oedema and mechanical stress.
Negative pressure wound therapy (NPWT) has been introduced as an alternative to traditional dressings for skin grafts. NPWT applies controlled suction to the wound environment, promoting fluid removal, enhancing blood flow, and potentially improving graft adherence and reducing infection risk. However, current evidence for NPWT in lower leg grafting is limited and inconclusive.
The Legs Trial is a multicentre, randomised controlled trial designed to compare NPWT with traditional dressings in adult patients undergoing STSG to the lower leg after tumour excision. The primary objective is to assess whether NPWT reduces the incidence of transplant infections within three months. Secondary outcomes include graft loss, reoperations, postoperative complications, hospital stay, and healthcare resource use.
Patients will be randomised to receive either NPWT or traditional dressing at the time of surgery. All patients will follow a structured postoperative mobilisation protocol and attend follow-up visits for outcome assessment.
The trial aims to generate high-quality evidence to inform best practices in postoperative management of lower leg skin grafts and optimise patient outcomes.
745 studies on the registry are indexed under Surgical Wound Infection; 151 are open to participants now.
This study's planned enrollment of 232 is above the median of 200 across 581 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.
Compared within Surgical Wound Infection, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Postoperative Complications. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Negative Pressure Wound Therapy (NPWT)
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.
Other: Traditional Dressing
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.
Also known as: VAC Therapy, Negative Pressure 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.
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.
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.
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.
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.
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.
Mortality within 3 months weeks after index surgery
All-cause mortality within 3 months after index surgery.
Time frame: From date of index surgery until 3 months postoperatively.
Length of hospital stay
Number of inpatient days related to the graft procedure.
Time frame: From date of index surgery until 3 months postoperatively.
Healthcare resource use within 3 months
Healthcare resource use based on costs of NPWT, traditional bandages, number of outpatient visits, use of antibiotics, and total days of hospitalisation within 3 months after index surgery.
Time frame: From date of index surgery until 3 months postoperatively.
Started Nov 2025 (actual). Primary completion is estimated for Jan 2030, 50 months after the start.
Of 201 non-industry interventional studies with no phase under Surgical Wound Infection, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 50 months is above that.
Counting every sponsor, half of 208 studies reached it within 24 months; a quarter within 12 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
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