Mohs Micrographic SurgeryBIOMOHSNCT07695389
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.
A study of Mohs Micrographic Surgery and Cutaneous Malignancy, run by BioLab Holdings at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mohs Micrographic Surgery, Cutaneous Malignancy, Mohs Surgical Defect
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2026to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- Toe-Brachial Index (TBI) ≥ 0.6;
- Transcutaneous Oxygen Measurement (TCOM) ≥ 40 mmHg;
- 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.
Who cannot join
- 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
- Requires immediate complex flap or graft reconstruction in the judgment of the surgeon.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Southside Dermatology Mohs and Skin Surgery
Tulsa, Oklahoma, 74132
Ana Montalva, (918) 760-0700, amontalva@dermatologyok.com
About this study
Official title: 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.
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.
Read the 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.
- Being tested
- Control Dressing + Standard of Care, CAMP + Standard of Care
- Keywords
- Mohs, Mohs micrographic surgery, Mohs surgical defect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Dressing + Standard of CareOther
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Dressing + Standard of Care | Active comparator | Standard of care will be cleaning, debridement, ulcer moisture balance, control dressing and offloading. Receives: 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. Receives: Other: CAMP + Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Wound Closure
The percentage of target wounds achieving complete wound closure in 6 weeks.
Measured: 1-6 Weeks
Secondary outcomes (10)
Time to Closure
Time to closure for the target wound.
Measured: 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.
Measured: 1-6 weeks
Procedure-Related Adverse Events
The number of product- or procedure-related adverse events.
Measured: 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.
Measured: 1-6 Weeks
Product or Procedure Adverse Events
The number of product- or procedure-related adverse events.
Measured: 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.
Measured: 1-6 weeks
Economic Outcomes
Health economic outcomes, including direct and indirect cost of care.
Measured: 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.
Measured: 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.
Measured: 12 Months
Time to Complete Granulation Tissue
Time to complete granulation tissue confirmed by independent assessment.
Measured: 1-6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start18 Sep 2026
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mohs Micrographic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioLab Holdings
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Responsible party
- Sponsor
- Investigators
- Thomas Serena, MD, Principal investigator, Serena Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695389
- Sponsor's protocol ID
- To be determined
- Acronym
- BIOMOHS
- Status last verified
- Sep 2026
- First submitted
- 6 Jul 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07695389
- Acronym / sponsor ID
- BIOMOHS / To be determined
- Keywords
- Mohs, Mohs micrographic surgery, Mohs surgical defect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- BioLab HoldingsIndustry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Study start
- 18 Sep 2026 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Dressing + Standard of Care | Active comparator | Other: Control Dressing + Standard of CareStandard of care will be cleaning, debridement, ulcer moisture balance, control dressing and offloading. |
| CAMP + Standard of Care | Other | Other: CAMP + Standard of CareMembrane Wrap-Lite is a human amniotic membrane tissue allograft derived from human placental tissue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (9 listed)
- 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:
- The potential subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control Dressing + Standard of CareBeginning 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 | Control Dressing + Standard of Care |
| CAMP + Standard of CareParticipants will receive weekly applications of Membrane Wrap-Lite and Standard of Care until ulcer closure, or a maximum of 6 weeks, whichever occurs first. | Other | CAMP + Standard of Care |
Primary outcome
Complete Wound Closure
Time frame: 1-6 Weeks
The percentage of target wounds achieving complete wound closure in 6 weeks.
10 secondary outcomes
Time to Closure
Time frame: 1-6 Weeks
Percentage Area Reduction
Time frame: 1-6 weeks
Procedure-Related Adverse Events
Time frame: 1-6 Weeks
Wound Volume Reduction
Time frame: 1-6 Weeks
Product or Procedure Adverse Events
Time frame: 1-6 Weeks
Numeric Pain Scale
Time frame: 1-6 weeks
Economic Outcomes
Time frame: 1-6 Weeks
Quality of Life
Time frame: 1- 6 Weeks
Scare and Cosmetic Outcomes
Time frame: 12 Months
Time to Complete Granulation Tissue
Time frame: 1-6 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Serena, MD principal investigator
Serena Group, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Mohs Micrographic Surgery and Cutaneous Malignancy, run by BioLab Holdings at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bennett Sarver (1-833-865-6300, info@serenagroups.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Wound Closure (time frame: 1-6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.