[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646077":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":33,"locations":24,"responsibleParty":39,"collaborators":41,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":24,"enrollmentInfo":54,"targetDuration":24,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":69,"whyStopped":24,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":24},{"fullName":5,"class":6},"BioLab Holdings","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Dressing + Standard of Care","ACTIVE_COMPARATOR","Standard of care will be cleaning, debridement, ulcer moisture balance, control dressing and offloading.",[13],"Other: Control Dressing + Standard of Care",{"label":15,"type":16,"description":17,"interventionNames":18},"CAMP + Standard of Care","OTHER","Membrane Wrap-Lite is a human amniotic membrane tissue allograft derived from human placental tissue.",[19],"Other: CAMP + Standard of Care",[21,25],{"type":16,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"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.",[9],null,{"type":16,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Participants will receive weekly applications of caregraFT™ and Standard of Care until ulcer closure, or a maximum of 6 weeks, whichever occurs first.",[15],[29],{"name":30,"affiliation":31,"role":32},"Thomas Serena, MD","Serena Group, Inc.","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Bennett Sarver","CONTACT","1-833-865-6300","info@serenagroups.com",{"type":40,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[42],{"name":43,"class":44},"SerenaGroup, Inc.","NETWORK","100646077","phase-4-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-100646077",false,"NCT07695389","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.","BIOMOHS","Inclusion Criteria:\n\n* The potential subject must be at least 18 years of age or older.\n* The potential subject must have undergone Mohs micrographic surgery for a cutaneous malignancy (e.g., basal cell carcinoma, or squamous cell carcinoma).\n* The potential subject must have a post-Mohs surgical defect that is suitable for treatment with a CAMP product or healing by secondary intention.\n* 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.\n* 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:\n\n  1. Ankle-Brachial Index (ABI) between 0.7 and ≤ 1.3;\n  2. Toe-Brachial Index (TBI) ≥ 0.6;\n  3. Transcutaneous Oxygen Measurement (TCOM) ≥ 40 mmHg;\n  4. Pulse Volume Recording (PVR): biphasic.\n* 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.\n* The potential subject must agree to attend the weekly study visits required by the protocol.\n* The potential subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria:\n\n* The potential subject is known to have a life expectancy of \\\u003C 6 months.\n* The potential subject's target wound is not secondary to a Mohs excision. -\n\n  -. The target wound is infected or there is cellulitis in the surrounding skin.\n* The target wound:\n\n  1. Exposes tendon, bone, or joint space, and\u002For\\[MM6.1\\]\\[RB6.2\\]\n  2. Requires immediate complex flap or graft reconstruction in the judgment of the surgeon.\n* The potential subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.\n* The potential subject has glycated hemoglobin (HbA1c) greater than 10% within 3 months of the initial screening visit.\n* The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.","ALL","18 Years",{"count":55,"type":56},160,"ESTIMATED","INTERVENTIONAL",[59],"PHASE4","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.",[62,63,64],"Undergone Mohs Micrographic Surgery","Cutaneous Malignancy","Mohs Surgical Defect",[66,67,68],"Mohs","undergone Mohs micrographic surgery","Mohs surgical defect","NOT_YET_RECRUITING","2026-07-06",{"date":72,"type":73},"2026-07-10","ACTUAL",{"date":75,"type":56},"2026-07-01",{"date":77,"type":56},"2028-07-01",{"name":5,"class":6}]