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

Официальное название

Assessing the Impact of a Disposable Negative Pressure Wound Therapy Device on Surgical Wounds of the Lower Extremities Following Mohs Micrographic Surgery

Обзор

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.

Подробное описание

PRIMARY OBJECTIVE:

I. To compare wound healing duration between the two groups, aiming to provide insights into the potential benefits of dNPWT for lower limb wounds in a clinical setting.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP 1: Patients undergo dNPWT with SNaP device following standard of care (SOC) Mohs surgery and attend follow-up visits with re-application of SNaP device over 30 minutes once a week (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 2: 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.

After completion of study intervention, patients are followed up at week 12.

Вмешательства

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

Первичные конечные точки

• Wound healing duration [Срок оценки: Up to 12 weeks]

Вторичные конечные точки (4)

• Mean time to wound closure [Срок оценки: Up to 12 weeks]
• Patient satisfaction [Срок оценки: At 12 weeks]
• Wound size progression [Срок оценки: Up to 12 weeks]
• Cosmetic outcomes [Срок оценки: At 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles

Идентификаторы

NCT: NCT07032701 · 24-5683 · NCI-2025-03606

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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