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.
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
Inability to follow postoperative instructions due to cognitive impairment, dementia, or significant language barriers
Inability to provide informed consent
Ongoing sepsis
Advanced heart failure
Parallel
Negative Pressure Wound Therapy (NPWT)
DeviceNegative 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 interventionTraditional 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 3 months after index surgery
Transplant infection defined as clinical infection of the skin graft diagnosed by a physician or confirmed by microbiological culture, occurring within 3 months after initial tumor excision and split-thickness skin grafting to the lower leg.
Graft loss within 3 months after index surgery
Graft loss defined as \<90% graft take at the graft site within 3 months after index surgery.
Reoperation within 3 months after index surgery
Proportion of participants requiring reoperation related to the graft site within 3 months after index surgery.
Bleeding within 3 months after index surgery
Incidence of clinically significant bleeding at the graft site requiring medical intervention within 3 months after index surgery.
Systemic complications within 3 months after index surgery
Incidence of systemic complications including deep vein thrombosis, pulmonary embolism, or myocardial infarction occurring within 3 months after index surgery.
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