CAMP plus standard care after Mohs surgery for skin defects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized study compares CAMP plus standard care to standard care alone in adults with skin defects after Mohs surgery. Participants are randomized after final Mohs stage and defect measurement and are treated with either CAMP plus standard care or a control dressing plus standard care. The trial focuses on healing outcomes for defects that can heal by secondary intention or with a topical matrix-like product. It is designed as a prospective, multicenter, randomized controlled trial to assess healing efficiency and safety. Enrollment criteria include adults with post-Mohs defects suitable for CAMP or secondary healing and adequate limb perfusion where applicable.

Why it matters

Who can join: the full rules

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.

Where it's running

• Southside Dermatology Mohs and Skin Surgery
  Tulsa, Oklahoma, United States Recruiting

Study contacts

• Principal investigator: Thomas Serena, MD — Serena Group, Inc.
• Study coordinator: Bennett Sarver
• Email: info@serenagroups.com
• Phone: 1-833-865-6300

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.