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.
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
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
Parallel
Best Practice
Other interventionUndergo SOC non-adherent dressing wound care
Educational Intervention
Other interventionReceive SNaP education
Educational Intervention
Other interventionReceive SOC wound care education
Electronic Health Record Review
Other interventionAncillary studies
Follow-Up Care
Other interventionAttend SNaP device follow-up visits
Follow-Up Care
Other interventionAttend SOC wound care follow-up visits
Medical Device Usage and Evaluation
Other interventionUndergo dNPWT with SNaP device
Negative Pressure Wound Therapy
Procedure/SurgeryUndergo dNPWT with SNaP device
Photography
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
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).
Mean time to wound closure
Among patients who achieve full healing, the mean time to wound closure will be compared between the SNaP device and standard care groups. If the data are normally distributed, an independent two-sample t-test will be used; otherwise, a Mann-Whitney U test will be applied.
Patient satisfaction
Patient satisfaction will be assessed using standardized questionnaires and analyzed with t-tests or chi-square tests to compare satisfaction levels between the SNaP device and standard care groups. Effect sizes and 95% confidence intervals will be reported to quantify the magnitude of treatment effects for all secondary outcomes.
Wound size progression
Wound size progression will be monitored over time and analyzed with repeated measures analysis of variance to assess changes within subjects. Effect sizes and 95% confidence intervals will be reported to quantify the magnitude of treatment effects for all secondary outcomes.
Cosmetic outcomes
Cosmetic outcomes, particularly scar appearance, will be evaluated using the Patient and Observer Scar and Assessment Scale 3.0, with mixed-effects models applied to account for patient variability and treatment effects. Furthermore, a multivariate analysis will be conducted to examine the combined effects of the SNaP device on both wound closure and cosmetic outcomes while adjusting for confounders such as age, comorbidities, and wound size. Effect sizes and 95% confidence intervals will be reported to quantify the magnitude of treatment effects for all secondary outcomes.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
