Recruiting

CAMP with Standard of Care

Sponsor:

BioLab Holdings

Code:

NCT07695389

Conditions

Mohs Micrographic Surgery

Cutaneous Malignancy

Mohs Surgical Defect

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Control Dressing + Standard of Care

CAMP + Standard of Care

Study Details

Brief summary:

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.

Conditions

Mohs Micrographic Surgery

Cutaneous Malignancy

Mohs Surgical Defect

Study ID

NCT07695389

Start date

Sep 18, 2026

Status verified date

Sep, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control Dressing + Standard of Care

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

other: CAMP + Standard of Care

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

Interventions

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.

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 measure

  • Complete Wound Closure [ Time Frame: 1-6 Weeks ]

Central Contacts and Locations

Central contacts

Locations

Southside Dermatology Mohs and Skin Surgery

Recruiting

Tulsa, Oklahoma, United States, 74132

Contacts

More Information

Sponsor

BioLab Holdings

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Keywords

  • Mohs
  • Mohs micrographic surgery
  • Mohs surgical defect

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by BioLab Holdings on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.