Negative Pressure Wound Therapy for Skin Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

Must not be taking: Steroids, Chemotherapy

Disqualifiers: Diabetes, Venous insufficiency, Arterial disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the SNaP Wound Care System, a new device, can aid in healing wounds on the lower legs after skin cancer surgery. The device uses a gentle vacuum to accelerate wound healing and is easy to use at home. Researchers are comparing it to the usual method of treating wounds with regular dressings. Individuals who recently underwent Mohs surgery on their lower legs for non-melanoma skin cancer may be suitable candidates, particularly if they do not have a history of diabetes or other conditions like smoking or recent chemotherapy. As an unphased trial, this study allows patients to contribute to innovative wound care research and potentially benefit from a new, convenient treatment option.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on chronic steroids or have used chemotherapy in the last year, you may not be eligible to participate.

What prior data suggests that the SNaP Wound Care System is safe for lower limb wound healing?

Research has shown that the SNaP Wound Care System, a disposable device for treating wounds, is generally well-tolerated. Studies have found that the SNaP device performs as well as traditional methods in aiding wound healing, with an 83.1% success rate. This indicates that the SNaP device is both effective and safe for wound care.

The SNaP system is designed to be light and easy to use, which can help prevent issues during use. This feature is especially beneficial for patients managing their wounds at home. While the device is generally safe, minor side effects like skin irritation or discomfort might occur, but these are rare and usually easy to manage.

Consult a healthcare provider to understand the potential risks and benefits for specific health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SNaP Wound Care System because it offers a novel approach to treating wounds from skin cancer surgery. Unlike traditional wound care, which often involves non-adherent dressings, the SNaP device uses a technique called negative pressure wound therapy (dNPWT). This method applies gentle suction to the wound area, which can promote faster healing by increasing blood flow and removing excess fluids. Additionally, the SNaP system is portable and easy to use, potentially allowing for more flexibility and comfort in a patient's daily life. This innovative approach could enhance recovery times and improve overall outcomes for patients after skin cancer surgery.

What evidence suggests that the SNaP device is effective for wound healing after Mohs surgery for non-melanoma skin cancer?

This trial will compare the SNaP Wound Care System with standard of care (SOC) wound care. Studies have shown that the SNaP Wound Care System effectively treats small wounds. This device uses negative pressure wound therapy (NPWT), which involves gentle suction to speed up healing by removing fluids. Unlike traditional NPWT devices, the SNaP system is lightweight and doesn't require an electric pump, making it easier to use. Research suggests it may be particularly beneficial for healing lower leg wounds after Mohs surgery for skin cancer. Early findings indicate that the SNaP system could offer a more convenient and effective way to promote wound healing outside of a hospital. ^{1 3 6 7 8}

Who Is on the Research Team?

Jeremy C Davis

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients who have had Mohs surgery for non-melanoma skin cancer on their lower limbs. It's designed to see if a portable wound therapy device helps with healing. Participants should be those needing post-Mohs surgery wound care.

Inclusion Criteria

My wound is smaller than 13 cm x 13 cm.

I have a wound on my lower limb from skin cancer surgery healing naturally.

I can change the SNAP-therapy system by myself at home.

Exclusion Criteria

I have smoked more than 10 pack-years or am currently smoking.

I have had a stroke before.

I have had deep vein thrombosis in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Mohs surgery followed by either dNPWT with SNaP device or SOC wound care, with weekly follow-up visits for up to 12 weeks

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for wound healing and patient satisfaction at week 12

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• SNaP Wound Care System

Trial Overview The study tests the SNaP device, a portable negative pressure wound therapy system, against standard care after Mohs surgery. The goal is to see if it better promotes healing in wounds on the lower limbs.

How Is the Trial Designed?

Group I: Group 1 (SNaP device dNPWT) Experimental Treatment 7 Interventions

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.

Group II: Group 2 (SOC wound care) Active Control 6 Interventions

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.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07032701

A Disposable Negative Pressure Wound Therapy Device ... This may be a more effective way to promote wound healing in the lower limbs following Mohs surgery for non-melanoma skin cancer. Detailed ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3839001/

SNaP® Wound Care System: Ultraportable Mechanically ... The Smart Negative Pressure (SNaP) Wound Care System is a novel light-weight NPWT device that does not require an electrically powered pump.

3. clin.larvol.com clin.larvol.com/trial-detail/NCT07032701

A Disposable Negative Pressure Wound Therapy Device ... Effect sizes and 95% confidence intervals will be reported to quantify the magnitude of treatment effects for all secondary outcomes. At 12 weeks. Wound size ...

4. withpower.com withpower.com/trial/phase-skin-carcinoma-11-2025-9753f

Negative Pressure Wound Therapy for Skin Cancer This clinical trial studies whether a disposable negative pressure wound therapy (dNPWT) device, SNaP Wound Care System (Ultraportable Mechanically Powered ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/iwj.13114

The smart negative pressure (SNaP) wound care system: A ... Ten studies were identified, showing that the SNaP wound care system is an effective tool in treating small-sized wounds and may serve as an ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7948783/

The smart negative pressure (SNaP) wound care system They demonstrated that the SNaP system was superior to modern dressings but equivalent to NPWT in terms of wound‐healing rate (83.1% versus 35.7% versus 83.1% ...

7. aetna.com aetna.com/cpb/medical/data/300_399/0334.html

Negative Pressure Wound Therapy The therapy appears to assist wound healing by decreasing wound bacterial burden and edema while facilitating granulation tissue formation. The latest ...

8. ucla.clinicaltrials.researcherprofiles.org ucla.clinicaltrials.researcherprofiles.org/trial/NCT07032701

Disposable Negative Pressure Wound Therapy Device (SNaP ... This clinical trial studies whether a disposable negative pressure wound therapy (dNPWT) device, SNaP Wound Care System (Ultraportable Mechanically Powered ...