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.

NCT07695389 | Not Yet Recruiting Phase 4

• 1 other identifier: To be determined
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Undergone Mohs Micrographic Surgery; Cutaneous Malignancy; Mohs Surgical Defect

Keywords

Mohs; undergone Mohs micrographic surgery; Mohs surgical defect

Outcome Measures

Primary Outcomes (1)

• Complete Wound Closure

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

  1-6 Weeks

Secondary Outcomes (10)

• Time to Closure

  1-6 Weeks

• Percentage Area Reduction

  1-6 weeks

• Procedure-Related Adverse Events

  1-6 Weeks

• Wound Volume Reduction

  1-6 Weeks

• Product or Procedure Adverse Events

  1-6 Weeks

Other Outcomes (2)

• Change in Perfusion

  1-6 Weeks

• Rate of Recurrence

  12 Months

Study Arms (2)

Control Dressing + Standard of Care

ACTIVE COMPARATOR

Standard of care will be cleaning, debridement, ulcer moisture balance, control dressing and offloading.

Other: Control Dressing + Standard of Care

CAMP + Standard of Care

OTHER

Membrane Wrap-Lite is a human amniotic membrane tissue allograft derived from human placental tissue.

Other: CAMP + Standard of Care

Interventions

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.

Control Dressing + Standard of Care

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.

CAMP + Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• BioLab Holdings: lead
• SerenaGroup, Inc.: collaborator

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Thomas Serena, MD

  Serena Group, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bennett Sarver

CONTACT

1-833-865-6300; info@serenagroups.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a multi-center, prospective, randomized controlled clinical study consisting of 160 subjects from up to 7 centers. The subjects are randomized to receive 1 of 2 treatments, either with Membrane Wrap-Lite™ (CAMP-1); and SOC. The target wounds are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of CAMP - 1 + SOC or SOC alone until or up to 6 weeks or until the study wound has completely closed (i.e. 100% closure as assessed by the investigator and confirmed 2 weeks later at the closure confirmation visit (CCV). One additional visit per week is optional for both arms, for the purpose of changing only (1) the secondary dressing in the CAMP arm or (2) change the standard of care dressing in the control arm.

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share