Clinical trial · Interventional
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.
NCT07695389CI-TRIAL-00117630BIOMOHSnot yet recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous Malignancy | — | UNRESOLVED | — |
| Mohs Surgical Defect | — | UNRESOLVED | — |
| Undergone Mohs Micrographic Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAMP + Standard of Care | Other | — | UNRESOLVED |
| Control Dressing + Standard of Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control Dressing + Standard of Care
- description
- Standard of care will be cleaning, debridement, ulcer moisture balance, control dressing and offloading.
- interventionNames
- Other: Control Dressing + Standard of Care
- type
- OTHER
- label
- CAMP + Standard of Care
- description
- Membrane Wrap-Lite is a human amniotic membrane tissue allograft derived from human placental tissue.
- interventionNames
- Other: CAMP + Standard of Care
Primary outcomes (1)
- measure
- Complete Wound Closure
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.