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NCT Number: NCT07695389

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.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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[MM6.1][RB6.2]
  • 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.

Treatment and study plan

Control Dressing + Standard of Care

Other

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.

CAMP + Standard of Care

Other

Participants will receive weekly applications of caregraFT™ and Standard of Care until ulcer closure, or a maximum of 6 weeks, whichever occurs first.

Primary outcomes

  1. Complete Wound Closure

    Time frame: 1-6 Weeks

    The percentage of target wounds achieving complete wound closure in 6 weeks.

Secondary outcomes

  1. Time to Closure

    Time frame: 1-6 Weeks

    Time to closure for the target wound.

  2. Percentage Area Reduction

    Time frame: 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.

  3. Procedure-Related Adverse Events

    Time frame: 1-6 Weeks

    The number of product- or procedure-related adverse events.

  4. Wound Volume Reduction

    Time frame: 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.

  5. Product or Procedure Adverse Events

    Time frame: 1-6 Weeks

    The number of product- or procedure-related adverse events.

  6. Numeric Pain Scale

    Time frame: 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.

  7. Economic Outcomes

    Time frame: 1-6 Weeks

    Health economic outcomes, including direct and indirect cost of care.

  8. Quality of Life

    Time frame: 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].

  9. Scare and Cosmetic Outcomes

    Time frame: 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.

  10. Time to Complete Granulation Tissue

    Time frame: 1-6 Weeks

    Time to complete granulation tissue confirmed by independent assessment.

Other outcomes

  1. Change in Perfusion

    Time frame: 1-6 Weeks

    • Changes in local perfusion at the surgical site over the 6-week treatment period, assessed via near-infrared spectroscopy.
  2. Rate of Recurrence

    Time frame: 12 Months

    The rate of recurrence within 12 months of closure when applicable.

Study contacts

Contact information is provided by the study sponsor or research team.

Bennett Sarver

CONTACT

[email protected]

1-833-865-6300

Sponsors and collaborators

Lead sponsor

BioLab Holdings

Industry

Collaborators

  • SerenaGroup, Inc.

Registry information

Acronym: BIOMOHS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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