Actively Recruiting
Negative Pressure Wound Therapy for Split Thickness Skin Grafting to the Lower Leg After Excision of Skin Tumour The Legs Trial - A Multicentre Randomised Study
Led by Region Skane · Updated on 2026-05-28
242
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effects of negative pressure wound therapy (NPWT) versus traditional dressings on the rate of transplant infections in adults undergoing split-thickness skin grafting (STSG) to the lower leg after skin tumour removal. The study also evaluates whether NPWT improves secondary outcomes like graft success, fewer reoperations, reduced complications, and better use of healthcare resources. The trial is a multicentre, randomised controlled study designed to provide clear evidence on postoperative care for lower leg skin grafts. Participants will be randomly assigned to receive either NPWT or traditional dressings applied over their skin graft after tumour excision. NPWT uses continuous suction at -125 mmHg with a protective interface until five days after surgery, while traditional dressings involve silicone interface layers and foam with gentle compression left undisturbed for five days. All patients will follow a structured postoperative care and mobilisation schedule to support healing. During the study, participants will attend follow-up visits on days 5 and 14 after surgery and be monitored through medical records for three months postoperatively. Researchers will assess outcomes including transplant infections, graft loss, reoperations, bleeding, complications, mortality, hospital stay length, and healthcare resource use. The total monitoring period spans from surgery until three months afterward to evaluate both primary and secondary outcomes.
CONDITIONS
Brief Title
Negative Pressure Wound Therapy for Split Thickness Skin Grafting to the Lower Leg After Excision of Skin Tumour: A Multicentre Randomised Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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, or end-stage renal or liver disease
- Active chemotherapy within the previous three months
- Ongoing treatment with immunosuppressive medications including systemic corticosteroids, calcineurin inhibitors, antimetabolites, mTOR inhibitors, biologic therapies, targeted molecular therapies, or other immunosuppressive drugs
- Previous radiation therapy to the surgical site
- Presence of severe skin disease affecting the planned graft recipient site, such as advanced psoriasis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 days post-surgery
Participants undergo excision of a skin tumour on the lower leg followed by split-thickness skin grafting. They then receive either negative pressure wound therapy (NPWT) or traditional dressing applied over the graft site.
1 surgical visit and dressing application, with dressing maintained until postoperative day 5 unless clinically indicated to change earlier
Duration - Up to 3 months post-surgery
Participants follow a structured postoperative mobilisation protocol and attend follow-up visits to assess wound healing, graft success, and monitor for complications such as infections or reoperations.
Multiple follow-up visits during the 3 months after surgery
Trial Site Locations
Total: 1 location
1
Dept. of Plastic and Reconstructive Surgery and Dept. of Health Sciences, Skåne University Hospital, Malmö, Sweden.
Malmö, Sweden, 20501
Actively Recruiting
Research Team
P
Pooya Rajabaleyan, MD, PhD
M
Mia Stiernman, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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