Cutaneous Malignancy, Mohs Surgical Defect, Undergone Mohs Micrographic Surgery
Conditions
Keywords
Mohs, undergone Mohs micrographic surgery, Mohs surgical defect
Brief summary
A multicenter, prospective, randomized controlled clinical trial assessing the efficacy of a novel cellular, acellular, matrix-like product (CAMP) plus standard of sare versus standard of sare slone in the management of post-mohs micrographic surgery defects.
Detailed description
This study will utilize a Prospective, Multicenter, Randomized Controlled Clinical Trial design. Subjects will be adult patients undergoing Mohs micrographic surgery with resulting post-excisional defects suitable for healing by secondary intention or management with a topical matrix-like product. Subjects will be randomized to receive: * CAMP plus Standard of Care (SOC), or * Control Dressing plus SOC. Randomization will occur after confirmation of final Mohs stage and measurement of the post-excisional defect.
Interventions
OTHERControl Dressing + Standard of Care
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 6 weeks, whichever occurs first.
OTHERCAMP + Standard of Care
Participants will receive weekly applications of caregraFT™ and Standard of Care until ulcer closure, or a maximum of 6 weeks, whichever occurs first.
Sponsors
BioLab Holdings
SerenaGroup, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a multi-center, prospective, randomized controlled clinical study consisting of 160 subjects from up to 7 centers. The subjects are randomized to receive 1 of 2 treatments, either with Membrane Wrap-Lite™ (CAMP-1); and SOC. The target wounds are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of CAMP - 1 + SOC or SOC alone until or up to 6 weeks or until the study wound has completely closed (i.e. 100% closure as assessed by the investigator and confirmed 2 weeks later at the closure confirmation visit (CCV). One additional visit per week is optional for both arms, for the purpose of changing only (1) the secondary dressing in the CAMP arm or (2) change the standard of care dressing in the control arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The potential subject must be at least 18 years of age or older. * The potential subject must have undergone Mohs micrographic surgery for a cutaneous malignancy (e.g., basal cell carcinoma, or squamous cell carcinoma). * The potential subject must have a post-Mohs surgical defect that is suitable for treatment with a CAMP product or healing by secondary intention. * The surgical site has received standard Mohs excision and hemostasis with no requirement for immediate flap or graft reconstruction as determined by the treating surgeon. * If the surgical defect is on the lower extremity, the limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable: 1. Ankle-Brachial Index (ABI) between 0.7 and ≤ 1.3; 2. Toe-Brachial Index (TBI) ≥ 0.6; 3. Transcutaneous Oxygen Measurement (TCOM) ≥ 40 mmHg; 4. Pulse Volume Recording (PVR): biphasic. * If the subject has multiple Mohs defects, they must be separated by at least 2 cm. The largest defect satisfying the inclusion and
Exclusion criteria
will be designated as the target wound. * The potential subject must agree to attend the weekly study visits required by the protocol. * The potential subject must be willing and able to participate in the informed consent process.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Wound Closure | 1-6 Weeks | The percentage of target wounds achieving complete wound closure in 6 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Closure | 1-6 Weeks | Time to closure for the target wound. |
| Percentage Area Reduction | 1-6 weeks | Percentage wound area reduction from TV-1 to TV-6 measured weekly with digital photographic planimetry using imaging device and physical examination. |
| Procedure-Related Adverse Events | 1-6 Weeks | The number of product- or procedure-related adverse events. |
| Wound Volume Reduction | 1-6 Weeks | Percentage wound volume reduction from TV-1 to TV-6 measured weekly with digital photographic planimetry using imaging device and physical examination. |
| Product or Procedure Adverse Events | 1-6 Weeks | The number of product- or procedure-related adverse events. |
| Numeric Pain Scale | 1-6 weeks | Change in pain at the target wound site assessed using a numeric pain scale. 0 being no pain and 10 being the worst pain imaginable. |
| Economic Outcomes | 1-6 Weeks | Health economic outcomes, including direct and indirect cost of care. |
| Quality of Life | 1- 6 Weeks | Change in quality of life, using the Wound Quality of Life questionnaire. \[Time frame: TV-1, TV-4, TV-6/final visit\]. |
| Scare and Cosmetic Outcomes | 12 Months | Scar and cosmetic outcomes at 12 months using the Patient and Observer Scar Assessment Scale (POSAS). 0 being normal and 10 being very different. |
| Time to Complete Granulation Tissue | 1-6 Weeks | Time to complete granulation tissue confirmed by independent assessment. |
Contacts
CONTACTBennett Sarver
PRINCIPAL_INVESTIGATORThomas Serena, MD
Serena Group, Inc.
Outcome results
None listed