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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

Study acronym: LEGS
StatusRecruiting
PhaseNot applicable
Started2025-11-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Region Skane

Amendment history

2026-08-30
Study Identification, Study Status, Study Description, Study Design, Outcome Measures v2
Primary endpoint(s) modified1 entry, revised
WasIncidence of transplant infection within 3 months after index surgery
NowIncidence of transplant infection within 2 weeks after index surgery
Primary completion date2029-12-31→2030-01-01
Enrollment target242→232
Secondary endpoints7 entries, revised
Graft loss withinpercentage 3graft monthstake afterat index2 surgeryweeks Reoperation within 32 monthsweeks after index surgery Bleeding within 32 monthsweeks after index surgery Systemic complicationsComplications within 3 months after index surgery Mortality within 3 months weeks after index surgery
Study title+67 characters
Lower Extremity Graft Study (LEGS): A Multicentre Randomised Controlled Trial of Negative Pressure Wound Therapy Versus Conventional Dressings for Split Thickness-thickness Skin GraftingGrafts to theAfter Lower Leg After Excision of Skin Tumour: A Multicentre Randomised StudyExcision
2026-05-27
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-12-31→2029-12-31
Completion date2028-03-31→2030-03-31
Study sitesdetails revised at 1 of 1 site
2025-06-24
Original filing
Region Skane
146 trials monitored
See 5 trials at risk
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.
Trial Details
NCT Number NCT07040683
Lead Sponsor Region Skane
Conditions Skin Transplantation, Skin Grafting, Split Thickness Skin Graft, Negative-Pressure Wound Therapy, Postoperative Complications, Surgical Wound Infection, Lower Extremity, Skin Cancer +4 more
Enrollment 232 participants
Start Date 2025-11-01
Primary Completion 2030-01-01 (estimated)
Study Completion 2030-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-02