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

Launched by REGION SKANE · Jun 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a special type of wound treatment called Negative Pressure Wound Therapy (NPWT) to see if it helps people heal better after skin graft surgery on the lower leg. The surgery involves removing a skin tumor and then covering the area with a thin layer of healthy skin from another part of the body (called a split-thickness skin graft). Researchers want to find out if using NPWT, which uses gentle suction to help the wound heal, can reduce infections and other problems compared to regular dressings like bandages.

Adults aged 18 and older who need this type of skin graft after tumor removal on their lower leg may be able to join the study, as long as they can follow post-surgery care instructions and attend follow-up visits. Participants will be randomly assigned to receive either the NPWT treatment or traditional dressings after surgery. They will have follow-up checks around 5 and 14 days after surgery and will be monitored for up to three months to see how well their graft heals and if any complications occur. This study hopes to find better ways to help wounds heal safely and reduce the need for extra treatments or hospital visits.

Gender

ALL

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)