Lower leg skin grafts after tumour removal: does negative pressure dressings help or not?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicentre randomized trial compares negative pressure wound therapy (NPWT) with conventional dressings for split-thickness skin grafts placed on the lower leg after tumour excision. Primary outcome is the rate of graft infection within three months; secondary outcomes include graft take, reoperations, complications, hospital stay, and resource use. Eligible adults undergoing lower-leg STSG are randomized to NPWT or traditional dressings and followed with a structured postoperative plan and visits. The study aims to provide high-quality evidence to guide dressing choices after leg skin grafting. Conducted in Skåne University Hospital, Malmö, the trial seeks to improve postoperative outcomes for patients undergoing skin tumour excision and grafting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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's running

• Dept. of Plastic and Reconstructive Surgery and Dept. of Health Sciences, Skåne University Hospital, Malmö, Sweden.
  Malmö, Sweden Recruiting

Study contacts

• Study coordinator: Pooya Rajabaleyan, MD, PhD
• Email: Pooya.rajabaleyan@skane.se
• Phone: +4640331000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.