A Disposable Negative Pressure Wound Therapy Device (SNaP) to Promote Wound Healing in the Lower Limbs Following Mohs Micrographic Surgery for Non-melanoma Skin Cancer

PRIMARY OBJECTIVE:

I. To compare wound healing duration between the two groups, aiming to provide insights into the potential benefits of dNPWT for lower limb wounds in a clinical setting.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP 1: Patients undergo dNPWT with SNaP device following standard of care (SOC) Mohs surgery and attend follow-up visits with re-application of SNaP device over 30 minutes once a week (QW), as needed until complete wound healing is achieved, for up to 12 weeks. Patients also receive education regarding SNaP device application and informational/educational SNaP device handouts on study.

GROUP 2: Patients undergo SOC wound care with non-adherent dressing following SOC Mohs surgery and attend follow-up visits with non-adherent dressing changes over 30 minutes QW, as needed until complete wound healing is achieved, for up to 12 weeks. Patients also receive education on SOC wound dressing changes on study.

After completion of study intervention, patients are followed up at week 12.

Inclusion criteria

• Aged 19 to 79 years
• Presenting with a lower limb wound following Mohs surgery for non-melanoma skin cancer, designated to heal by secondary intention
• Wound size less than 13 cm x 13 cm
• Patient capable of changing the SNAP-therapy system at home

Exclusion criteria

• History of diabetes mellitus
• History of venous insufficiency
• History peripheral arterial disease
• Chronic steroid use (defined as great than 6 weeks) within the last one year
• History of HIV
• History of chemotherapy use within the last one year
• History of smoking exceeding 10 pack-years or current smoker
• History of stroke
• History of deep venous thrombosis
• Active infection
• Allergy to adhesives
• Wounds with visible bone, tendon, ligament, nerve