Clinical trial · Interventional
Lower Extremity Graft Study (LEGS): A Multicentre Randomised Controlled Trial of Negative Pressure Wound Therapy Versus Conventional Dressings for Split-thickness Skin Grafts After Lower Leg Skin Tumour Excision
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 graft infection within 2 weeks 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
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bandages | — | UNRESOLVED | — |
| Leg | — | UNRESOLVED | — |
| Lower Extremity | — | UNRESOLVED | — |
| Negative-Pressure Wound Therapy | — | UNRESOLVED | — |
| Postoperative Complications | — | UNRESOLVED | — |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
| Skin Grafting | — | UNRESOLVED | — |
| Skin Transplantation | — | UNRESOLVED | — |
| Skin Tumour | Skin Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Negative Pressure Wound Therapy (NPWT) | Device | — | UNRESOLVED |
| Traditional Dressing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Negative Pressure Wound Therapy (NPWT)
- description
- 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.
- interventionNames
- Device: Negative Pressure Wound Therapy (NPWT)
- type
- ACTIVE_COMPARATOR
- label
- Traditional Dressings
- description
- 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.
- interventionNames
- Other: Traditional Dressing
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available