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

NCT07032701 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: 24-5683NCI-2025-03606
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Wound healing duration

  Will be defined as the number of days from surgery to complete wound closure (full re-epithelialization), assessed during follow-up visits. Will be analyzed as a time-to-event variable. To compare the time to wound closure between the SNaP Wound Care System (Ultraportable Mechanically Powered Negative Pressure Wound Therapy) (SNaP) device and standard care groups, Kaplan-Meier survival curves will be generated, which will visually illustrate whether the SNaP device accelerates wound healing. The log-rank test will be used to formally assess whether the difference in healing times between the two groups is statistically significant or if any differences observed could have arisen by random chance. Additionally, a Multivariable Cox proportional hazards model will be employed to adjust for potential confounders (e.g., wound size, patient age, and comorbidities).

  Up to 12 weeks

Secondary Outcomes (4)

• Mean time to wound closure

  Up to 12 weeks

• Patient satisfaction

  At 12 weeks

• Wound size progression

  Up to 12 weeks

• Cosmetic outcomes

  At 12 weeks

Study Arms (2)

Group 1 (SNaP device dNPWT)

EXPERIMENTAL

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.

Other: Educational Intervention; Other: Electronic Health Record Review; Other: Follow-Up Care; Other: Medical Device Usage and Evaluation; Procedure: Negative Pressure Wound Therapy; Other: Photography; Other: Questionnaire Administration

Group 2 (SOC wound care)

ACTIVE COMPARATOR

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.

Other: Best Practice; Other: Educational Intervention; Other: Electronic Health Record Review; Other: Follow-Up Care; Other: Photography; Other: Questionnaire Administration

Interventions

Electronic Health Record Review OTHER

Ancillary studies

Group 1 (SNaP device dNPWT); Group 2 (SOC wound care)

Follow-Up Care OTHER

Attend SNaP device follow-up visits

Group 1 (SNaP device dNPWT)

Medical Device Usage and Evaluation OTHER

Undergo dNPWT with SNaP device

Group 1 (SNaP device dNPWT)

Best Practice OTHER

Undergo SOC non-adherent dressing wound care

Also known as: standard of care, standard therapy

Group 2 (SOC wound care)

Educational Intervention OTHER

Receive SNaP education

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Group 1 (SNaP device dNPWT)

Negative Pressure Wound Therapy PROCEDURE

Undergo dNPWT with SNaP device

Also known as: NPWT, Vacuum-Assisted Wound Closure

Group 1 (SNaP device dNPWT)

Photography OTHER

Ancillary studies

Group 1 (SNaP device dNPWT); Group 2 (SOC wound care)

Questionnaire Administration OTHER

Ancillary studies

Group 1 (SNaP device dNPWT); Group 2 (SOC wound care)

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care; Early Intervention, Educational; Educational Status; Methods; Aftercare; Negative-Pressure Wound Therapy; Photography

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Continuity of Patient Care; Patient Care; Therapeutics; Primary Health Care; Comprehensive Health Care; Patient Care Management; Drainage; Surgical Procedures, Operative; Wound Closure Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jeremy C Davis

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 24, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2031
• Last Updated: April 2, 2026

Record last verified: 2026-04

Locations

US (1)