An interventional study of Control Dressing + Standard of Care and CAMP + Standard of Care in Mohs Micrographic Surgery, Cutaneous Malignancy and Mohs Surgical Defect, sponsored by BioLab Holdings. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by BioLab Holdings · Not applicable, Interventional, and Treatment
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.
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:
BioLab Holdings is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 1, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
The target wound:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard of care will be cleaning, debridement, ulcer moisture balance, control dressing and offloading.
Other: Control Dressing + Standard of Care
Membrane Wrap-Lite is a human amniotic membrane tissue allograft derived from human placental tissue.
Other: CAMP + 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.
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.
Complete Wound Closure
The percentage of target wounds achieving complete wound closure in 6 weeks.
Time frame: 1-6 Weeks
Time to Closure
Time to closure for the target wound.
Time frame: 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.
Time frame: 1-6 weeks
Procedure-Related Adverse Events
The number of product- or procedure-related adverse events.
Time frame: 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.
Time frame: 1-6 Weeks
Product or Procedure Adverse Events
The number of product- or procedure-related adverse events.
Time frame: 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.
Time frame: 1-6 weeks
Economic Outcomes
Health economic outcomes, including direct and indirect cost of care.
Time frame: 1-6 Weeks
Quality of Life
Change in quality of life, using the Wound Quality of Life Questionnaire, with items scored 0-4, where higher scores indicate worse quality of life.
Time frame: 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.
Time frame: 12 Months
Time to Complete Granulation Tissue
Time to complete granulation tissue confirmed by independent assessment.
Time frame: 1-6 Weeks
Change in Perfusion
Changes in local perfusion at the surgical site over the 6-week treatment period, assessed via near-infrared spectroscopy.
Time frame: 1-6 Weeks
Rate of Recurrence
The rate of recurrence within 12 months of closure when applicable.
Time frame: 12 Months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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