Portable Wound Dressing Device for Leg Wounds After Skin Cancer Surgery

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a lower leg wound left open to heal after Mohs surgery for non-melanoma skin cancer. It tests a disposable wound therapy device against standard wound care.

Age

19 to 79 years

Sex

All sexes can join.

Disease stage

A lower limb wound after Mohs surgery for non-melanoma skin cancer, left to heal on its own. The wound must be smaller than 13 cm (5.1 in) x 13 cm (5.1 in).

Earlier treatment

No chemotherapy within the last year. No long-term steroid use (more than 6 weeks) within the last year.

Main reasons for not taking part

• History of diabetes, venous insufficiency, peripheral arterial disease, stroke or deep venous thrombosis
• History of HIV
• Smoking history above 10 pack-years, or current smoker
• Active infection or allergy to adhesives
• Wounds with visible bone, tendon, ligament or nerve

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 19 and 79 years old?YesNo

What the trial wants to find out

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.

The 2 groups in the trial

• Group 1 (SNaP device dNPWT)Treatment being tested

  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.

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

• Group 2 (SOC wound care)Existing treatment, for comparison

  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.

  Treatment: Best Practice, Educational Intervention, Electronic Health Record Review, Follow-Up Care, Photography, and Questionnaire Administration