NCT07695389 · BioLab Holdings
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.
(BIOMOHS)
What this study is about
A conducted at multiple hospitals, forward-looking, randomly assigned controlled clinical trial assessing the effectiveness of a novel cellular, acellular, matrix-like product (CAMP) plus the usual treatment versus the usual treatment alone in the management of post-mohs micrographic surgery defects.
View original scientific description
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.
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.
Primary outcome measures
Complete Wound Closure
Time frame: 1-6 Weeks
The percentage of target wounds achieving complete wound closure in 6 weeks.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- Ankle-Brachial Index (ABI) between 0.7 and ≤ 1.3;
- Toe-Brachial Index (TBI) ≥ 0.6;
- Transcutaneous Oxygen Measurement (TCOM) ≥ 40 mmHg;
- 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:
- Exposes tendon, bone, or joint space, and/or
- 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.
Where
- Tulsa, Oklahoma
Collaborators
SerenaGroup, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 1, 2026 · Source of record for eligibility and locations