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RECRUITING

NCT07695389

Efficacy of a Novel Cellular, Acellular, Matrix-like Product (CAMP) Plus Standard of Care Versus Standard of Care Alone in the Management of Post-Mohs Micrographic Surgery Defects.

Sponsor: BioLab Holdings

View on ClinicalTrials.gov

Summary

A multicenter, prospective, randomized controlled clinical trial assessing the efficacy of a novel cellular, acellular, matrix-like product (CAMP) plus standard of care versus standard of care alone in the management of post-mohs micrographic surgery defects.

Official title: A Multicenter, Prospective, Randomized Controlled Clinical Trial Assessing the Efficacy of a Novel Cellular, Acellular, Matrix-like Product (CAMP) Plus Standard of Care Versus Standard of Care Alone in the Management of Post-Mohs Micrographic Surgery Defects.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-09-18

Completion Date

2028-07-01

Last Updated

2026-10-01

Healthy Volunteers

Conditions

Mohs Micrographic Surgery Cutaneous Malignancy Mohs Surgical Defect

Interventions

OTHER

Control 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.

OTHER

CAMP + Standard of Care

Participants will receive weekly applications of Membrane Wrap-Lite and Standard of Care until ulcer closure, or a maximum of 6 weeks, whichever occurs first.

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. Exclusion Criteria: * The potential subject is known to have a life expectancy of \< 6 months. * The potential subject's target wound is not secondary to a Mohs excision. * The target wound is infected or there is cellulitis in the surrounding skin. * The target wound: 1. Exposes tendon, bone, or joint space, and/or 2. Requires immediate complex flap or graft reconstruction in the judgment of the surgeon. * The potential subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days. * The potential subject has glycated hemoglobin (HbA1c) greater than 10% within 3 months of the initial screening visit. * The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.

Locations (1)

Southside Dermatology Mohs and Skin Surgery

Tulsa, Oklahoma, United States