Skin CarcinomaNCT07032701
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
A study testing Best Practice, Educational Intervention and Electronic Health Record Review in people with Skin Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Skin Carcinoma
- What is being tested?
- Best Practice, Educational Intervention and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Jeremy C. Davis, JeremyDavis@mednet.ucla.edu
Jeremy C. Davis
About this study
Official title: Assessing the Impact of a Disposable Negative Pressure Wound Therapy Device on Surgical Wounds of the Lower Extremities Following Mohs Micrographic Surgery
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Conditions
- Skin Carcinoma
- Being tested
- Best Practice, Educational Intervention, Electronic Health Record Review, Follow-Up Care, Medical Device Usage and Evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Undergo SOC non-adherent dressing wound care
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive SNaP education
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive SOC wound care education
Electronic Health Record ReviewOther
Ancillary studies
Follow-Up CareOther
Attend SNaP device follow-up visits
Follow-Up CareOther
Attend SOC wound care follow-up visits
Medical Device Usage and EvaluationOther
Undergo dNPWT with SNaP device
Negative Pressure Wound TherapyProcedure or surgery
Also called NPWT, Vacuum-Assisted Wound Closure
Undergo dNPWT with SNaP device
PhotographyOther
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Best Practice; Other: Educational Intervention; Other: Electronic Health Record Review; Other: Follow-Up Care; Other: Photography; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 12 weeks
Secondary outcomes (4)
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.
Measured: Up to 12 weeks
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.
Measured: At 12 weeks
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.
Measured: Up to 12 weeks
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.
Measured: At 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study startDec 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CarcinomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeremy C Davis, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032701
- Sponsor's protocol ID
- 24-5683
- Other IDs
- NCI-2025-03606
- Status last verified
- Apr 2026
- First submitted
- 16 Jun 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of a Disposable Negative Pressure Wound Therapy Device on Surgical Wounds of the Lower Extremities Following Mohs Micrographic Surgery
- ClinicalTrials.gov ID
- NCT07032701
- Acronym / sponsor ID
- 24-5683
- Conditions
- Skin Carcinoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (SNaP device dNPWT) | Experimental | 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 AdministrationPatients 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 2 (SOC wound care) | Active comparator | Other: Best Practice, Other: Educational Intervention, Other: Electronic Health Record Review, Other: Follow-Up Care, Other: Photography, Other: Questionnaire AdministrationPatients 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 may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyUndergo SOC non-adherent dressing wound care | Other | Group 2 (SOC wound care) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive SNaP education | Other | Group 1 (SNaP device dNPWT) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive SOC wound care education | Other | Group 2 (SOC wound care) |
| Electronic Health Record ReviewAncillary studies | Other | Group 1 (SNaP device dNPWT), Group 2 (SOC wound care) |
| Follow-Up CareAttend SNaP device follow-up visits | Other | Group 1 (SNaP device dNPWT) |
| Follow-Up CareAttend SOC wound care follow-up visits | Other | Group 2 (SOC wound care) |
| Medical Device Usage and EvaluationUndergo dNPWT with SNaP device | Other | Group 1 (SNaP device dNPWT) |
| Negative Pressure Wound TherapyAlso: NPWT, Vacuum-Assisted Wound ClosureUndergo dNPWT with SNaP device | Procedure or surgery | Group 1 (SNaP device dNPWT) |
| PhotographyAncillary studies | Other | Group 1 (SNaP device dNPWT), Group 2 (SOC wound care) |
| Questionnaire AdministrationAncillary studies | Other | Group 1 (SNaP device dNPWT), Group 2 (SOC wound care) |
Primary outcome
Wound healing duration
Time frame: Up to 12 weeks
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).
4 secondary outcomes
Mean time to wound closure
Time frame: Up to 12 weeks
Patient satisfaction
Time frame: At 12 weeks
Wound size progression
Time frame: Up to 12 weeks
Cosmetic outcomes
Time frame: At 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
Related trials for Skin Carcinoma
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
RecruitingObservational study
Negative/Low Hormone Receptor And/or HER2 POsitive Lobular Invasive Breast Carcinoma - A Real-World International Cohort Study
Lobular Breast Carcinoma
RecruitingPhase 2
Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeremy C Davis principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Educational Intervention and Electronic Health Record Review in people with Skin Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing duration (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.