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. (BIOMOHS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cutaneous Malignancy; Undergone Mohs Micrographic Surgery; Mohs Surgical Defect
• Intervention / Treatment: Other: Control Dressing + Standard of Care; Other: CAMP + Standard of Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Bennett Sarver; Phone Number: 1-833-865-6300; Email: info@serenagroups.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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[MM6.1][RB6.2]
  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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Dressing + Standard of Care; Standard of care will be cleaning, debridement, ulcer moisture balance, control dressing and offloading.	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; Membrane Wrap-Lite is a human amniotic membrane tissue allograft derived from human placental tissue.	Other: CAMP + 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Wound Closure	The percentage of target wounds achieving complete wound closure in 6 weeks.	1-6 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Closure	Time to closure for the target wound.	1-6 Weeks
Percentage Area Reduction	Percentage wound area reduction from TV-1 to TV-6 measured weekly with digital photographic planimetry using imaging device and physical examination.	1-6 weeks
Procedure-Related Adverse Events	The number of product- or procedure-related adverse events.	1-6 Weeks
Wound Volume Reduction	Percentage wound volume reduction from TV-1 to TV-6 measured weekly with digital photographic planimetry using imaging device and physical examination.	1-6 Weeks
Product or Procedure Adverse Events	The number of product- or procedure-related adverse events.	1-6 Weeks
Numeric Pain Scale	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.	1-6 weeks
Economic Outcomes	Health economic outcomes, including direct and indirect cost of care.	1-6 Weeks
Quality of Life	Change in quality of life, using the Wound Quality of Life questionnaire. [Time frame: TV-1, TV-4, TV-6/final visit].	1- 6 Weeks
Scare and Cosmetic Outcomes	Scar and cosmetic outcomes at 12 months using the Patient and Observer Scar Assessment Scale (POSAS). 0 being normal and 10 being very different.	12 Months
Time to Complete Granulation Tissue	Time to complete granulation tissue confirmed by independent assessment.	1-6 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Perfusion	1. Changes in local perfusion at the surgical site over the 6-week treatment period, assessed via near-infrared spectroscopy.	1-6 Weeks
Rate of Recurrence	The rate of recurrence within 12 months of closure when applicable.	12 Months

Collaborators and Investigators

• Sponsor: BioLab Holdings
• Collaborators: SerenaGroup, Inc.
• Investigators: Principal Investigator: Thomas Serena, MD, Serena Group, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Mohs; undergone Mohs micrographic surgery; Mohs surgical defect
• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: To be determined

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No