Negative Pressure Wound Therapy for Split Thickness Skin Grafting to the Lower Leg After Excision of Skin Tumour: A Multicentre Randomised Study

Recruiting now · Not applicable

Conditions studied: Skin Transplantation, Skin Grafting, Split Thickness Skin Graft, Negative-Pressure Wound Therapy, Postoperative Complications, Surgical Wound Infection, Lower Extremity, Skin Cancer, Skin Tumour, Wound Healing, Bandages, Leg

In brief

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.

Key facts

Study ID

NCT07040683

Run by

Region Skane

People needed

242

Starts

2025-11-01

Expected to finish

2030-03-31

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Dept. of Plastic and Reconstructive Surgery and Dept. of Health Sciences, Skåne University Hospital, Malmö, Sweden. — Malmö, Sweden (enrolling)

Full record on ClinicalTrials.gov

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