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

Summary

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.

Conditions

• Skin Carcinoma

Interventions

OTHER

Best Practice

Undergo SOC non-adherent dressing wound care

OTHER

Educational Intervention

Receive SNaP education

OTHER

Educational Intervention

Receive SOC wound care education

OTHER

Electronic Health Record Review

Ancillary studies

OTHER

Follow-Up Care

Attend SNaP device follow-up visits

OTHER

Follow-Up Care

Attend SOC wound care follow-up visits

OTHER

Medical Device Usage and Evaluation

Undergo dNPWT with SNaP device

PROCEDURE

Negative Pressure Wound Therapy

Undergo dNPWT with SNaP device

OTHER

Photography

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Jeremy C Davis · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-30

Primary Completion

2030-06-30

Completion

2031-06-30

FDA Device

Yes

Countries

• United States

Study Locations