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

Official 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

Overview

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.

Detailed description

Split-thickness skin grafting (STSG) to the lower leg is a common surgical procedure performed after excision of skin tumours, particularly when primary closure is not feasible. Although the technique is well established, postoperative infections and graft-related complications remain a clinical challenge, especially in lower leg wounds, which are prone to oedema and mechanical stress.

Negative pressure wound therapy (NPWT) has been introduced as an alternative to traditional dressings for skin grafts. NPWT applies controlled suction to the wound environment, promoting fluid removal, enhancing blood flow, and potentially improving graft adherence and reducing infection risk. However, current evidence for NPWT in lower leg grafting is limited and inconclusive.

The Legs Trial is a multicentre, randomised controlled trial designed to compare NPWT with traditional dressings in adult patients undergoing STSG to the lower leg after tumour excision. The primary objective is to assess whether NPWT reduces the incidence of transplant infections within three months. Secondary outcomes include graft loss, reoperations, postoperative complications, hospital stay, and healthcare resource use.

Patients will be randomised to receive either NPWT or traditional dressing at the time of surgery. All patients will follow a structured postoperative mobilisation protocol and attend follow-up visits for outcome assessment.

The trial aims to generate high-quality evidence to inform best practices in postoperative management of lower leg skin grafts and optimise patient outcomes.

Interventions

• Device Negative Pressure Wound Therapy (NPWT)
  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.
• Other Traditional Dressing
  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.

Primary outcome measures

• Incidence of transplant infection within 3 months after index surgery [Time frame: From date of index surgery until 3 months postoperatively.]

Secondary outcome measures (7)

• Graft loss within 3 months after index surgery [Time frame: From date of index surgery until 3 months postoperatively.]
• Reoperation within 3 months after index surgery [Time frame: From date of index surgery until 3 months postoperatively.]
• Bleeding within 3 months after index surgery [Time frame: From date of index surgery until 3 months postoperatively.]
• Systemic complications within 3 months after index surgery [Time frame: From date of index surgery until 3 months postoperatively.]
• Mortality within 3 months after index surgery [Time frame: From date of index surgery until 3 months postoperatively.]
• Length of hospital stay [Time frame: From date of index surgery until 3 months postoperatively.]
• Healthcare resource use within 3 months [Time frame: From date of index surgery until 3 months postoperatively.]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Sweden · 1 center

• Dept. of Plastic and Reconstructive Surgery and Dept. of Health Sciences, Skåne University — Malmö

Identifiers

NCT: NCT07040683 · 2024-05592-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗