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

NCT07040683 | Not Yet Recruiting

• 1 other identifier: 2024-05592-01
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Skin Transplantation; Skin Grafting; Split Thickness; Negative-Pressure Wound Therapy; Postoperative Complications; Surgical Wound Infection; Lower Extremity; Wound Healing; Bandages; Leg; Skin Neoplasms; Skin Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  From date of index surgery until 3 months postoperatively.

Secondary Outcomes (7)

• Graft loss within 3 months after index surgery

  From date of index surgery until 3 months postoperatively.

• Reoperation within 3 months after index surgery

  From date of index surgery until 3 months postoperatively.

• Bleeding within 3 months after index surgery

  From date of index surgery until 3 months postoperatively.

• Systemic complications within 3 months after index surgery

  From date of index surgery until 3 months postoperatively.

• Mortality within 3 months after index surgery

  From date of index surgery until 3 months postoperatively.

Study Arms (2)

Negative Pressure Wound Therapy (NPWT)

EXPERIMENTAL

Participants in this arm will receive negative pressure wound therapy (NPWT) applied over the split-thickness skin graft after excision of a skin tumour on the lower leg. NPWT will be applied according to manufacturer instructions, using a protective interface layer and continuous negative pressure of -125 mmHg until postoperative day 5.

Device: Negative Pressure Wound Therapy (NPWT)

Traditional Dressings

ACTIVE COMPARATOR

Participants in this arm will receive traditional dressings applied over the split-thickness skin graft after excision of a skin tumour on the lower leg. The dressing will include a protective silicone interface layer and foam dressing with gentle compression, left undisturbed until postoperative day 5.

Other: Traditional Dressing

Interventions

Negative Pressure Wound Therapy (NPWT) DEVICE

Negative 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.

Also known as: VAC Therapy, Negative Pressure Dressing

Negative Pressure Wound Therapy (NPWT)

Traditional Dressing OTHER

Traditional 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.

Traditional Dressings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

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

Malmo, 20501, Sweden

Location

MeSH Terms

Conditions

Postoperative Complications; Surgical Wound Infection; Skin Neoplasms

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wound Infection; Infections; Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Central Study Contacts

Pooya Rajabaleyan, MD, PhD

CONTACT

+4640331000; Pooya.rajabaleyan@skane.se

Mia Stiernman, MD, PhD

CONTACT

+4640331000; mia.stiernman@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Model Details: Participants will be randomly assigned in a 1:1 ratio to receive either negative pressure wound therapy (NPWT) or traditional dressings after split-thickness skin grafting to the lower leg. Each participant will remain in their assigned treatment group for the duration of the study, with outcomes assessed at follow-up visits and by medical record review up to three months postoperatively.

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 27, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

SE (1)