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

Conditions

• Skin Carcinoma

Eligibility Criteria

Sex

ALL

Age

19 Years - 79 Years

Healthy Volunteers

Not accepted

Interventions

• Best Practice — OTHER
  Undergo SOC non-adherent dressing wound care
• Educational Intervention — OTHER
  Receive SNaP education
• Educational Intervention — OTHER
  Receive SOC wound care education
• Electronic Health Record Review — OTHER
  Ancillary studies
• Follow-Up Care — OTHER
  Attend SNaP device follow-up visits
• Follow-Up Care — OTHER
  Attend SOC wound care follow-up visits
• Medical Device Usage and Evaluation — OTHER
  Undergo dNPWT with SNaP device
• Negative Pressure Wound Therapy — PROCEDURE
  Undergo dNPWT with SNaP device
• Photography — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

This clinical trial studies whether a disposable negative pressure wound therapy (dNPWT) device, SNaP Wound Care System (Ultraportable Mechanically Powered Negative Pressure Wound Therapy) (SNaP), promotes wound healing in the lower limbs in patients that have undergone Mohs micrographic surgery (Mohs surgery) for non-melanoma skin cancer. Mohs surgery is a surgical technique used to treat skin cancer. Individual layers of cancerous tissue are removed and examined under a microscope one at a time until all cancerous tissue has been removed. It is an important part of removing skin cancer, but it often leads to soft-tissue defects and reconstructive challenges, especially in high-tension areas like the lower limbs. Typically, these wounds are managed by leaving them open and allowing them to heal from the base up or are reconstructed by transferring healthy skin from another part of the body. Negative pressure wound therapy (NPWT) is a wound dressing system that continuously or intermittently applies subatmospheric pressure to the surface of a wound to draw out fluid and promote healing. The SNaP device is a dNPWT device for lower leg wound healing designed for increased portability and ease of use outside of a hospital setting. It is a modification of traditional NPWT devices that uses springs to generate pressure, making it lighter and more user-friendly than traditional devices that rely on electrically powered pumps. This may be a more effective way to promote wound healing in the lower limbs following Mohs surgery for non-melanoma skin cancer.

Key Dates

Start date

Jun 30, 2026

Status verified

Apr 2026

Primary completion

Jun 30, 2030

Completion

Jun 30, 2031

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Group 1 (SNaP device dNPWT)
  Patients undergo dNPWT with SNaP device following SOC Mohs surgery and attend follow-up visits with re-application of SNaP device over 30 minutes 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.
• Active Comparator: Group 2 (SOC wound care)
  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.

Primary Outcome Measure

Wound healing duration [ Time Frame: Up to 12 weeks ]

Locations (1)

Find similar trials in Los Angeles, CA

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