[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646029":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":99,"collaborators":101,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":107,"sex":113,"minAge":114,"maxAge":26,"enrollmentInfo":115,"targetDuration":26,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":125,"overallStatus":129,"whyStopped":26,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Imbed Biosciences","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Arm - Proximal or Distal DSW location","EXPERIMENTAL","Treatment with Microlyte DualGuard (investigational device)",[13],"Device: Microlyte DualGuard",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care Arm - opposite side of DSW from treatment arm","ACTIVE_COMPARATOR","The DSW will have a side (proximal or distal) that is randomized to Microlyte DualGuard. The opposite side (proximal or distal) will be treated with standard of care foam dressing (Allevyn).",[19],"Device: Allevyn Foam (Standard of Care Control)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Microlyte DualGuard","Microlyte® DualGuard wound dressing: It is a sterile, single use synthetic polyvinyl alcohol absorbent sheet with ionic gallium, and with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver and gallium with maximum of 0.16 mg\u002Fsq. in. and 1 mg\u002Fsq. in., respectively. Microlyte® DualGuard wound dressing absorbs wound fluid and forms a soft gel that conforms to the wound surface and maintains a moist environment. The dressing contains silver and gallium only to prevent or minimize microbial growth within the dressing.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Allevyn Foam (Standard of Care Control)","Allevyn® is indicated for as wound management by secondary intention on shallow, granulating wounds, chronic and acute exuding wounds, full- and partial-thickness wounds including: leg ulcers, diabetic foot ulcers, surgical wounds, first- and second-degree burns, skin graft donor site, skin tears, and pressure injuries.",[15],[32],{"name":33,"affiliation":34,"role":35},"Kevin Foster, MD, MBA, FACS","Valleywise Health Medical Center","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Brad Wiggins, BSN, RN, CBRN","CONTACT","888-472-9898","bwiggins@imbedbio.com",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Carrie M Huffman, MA, MPH, DLP, RAC-US","301-337-8159","chuffman@imbedbio.com",[47,65,82],{"facility":34,"status":26,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Phoenix","Arizona","85008","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-112.07404,33.44838,{"lat":57,"lon":56},[60,64],{"name":61,"role":39,"phone":62,"phoneExt":26,"email":63},"Lora Nordstrom, PHD, BSN, CCRC, CHRC","602-344-2759","lora.nordstrom@valleywisehealth.org",{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":66,"status":26,"city":67,"state":68,"zip":69,"country":51,"countryCode":52,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Medstar Washington Hospital Center","Washington D.C.","District of Columbia","20010",{"type":54,"coordinates":71},[72,73],-77.03637,38.89511,{"lat":73,"lon":72},[76,80],{"name":77,"role":39,"phone":78,"phoneExt":26,"email":79},"Melissa McLawhorn, RN, BSN","202-877-6181","melissa.m.mclawhorn@medstar.net",{"name":81,"role":35,"phone":26,"phoneExt":26,"email":26},"Jeffrey W Shupp, MD",{"facility":83,"status":26,"city":84,"state":85,"zip":86,"country":51,"countryCode":52,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"University Medical Center New Orleans, LSU Health NOLA","New Orleans","Louisiana","70112",{"type":54,"coordinates":88},[89,90],-90.07507,29.95465,{"lat":90,"lon":89},[93,97],{"name":94,"role":39,"phone":95,"phoneExt":26,"email":96},"Shana Lennard, RN, BSN, CCRP","504-702-5171","slenna@lsuhsc.edu",{"name":98,"role":35,"phone":26,"phoneExt":26,"email":26},"Jeffrey E Carter, MD, FACS, FABA",{"type":100,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[102],{"name":103,"class":104},"United States Department of Defense","FED","100646029","safety-study-of-microlyte-dualguard-100646029",false,"NCT07695688","Safety Study of Microlyte DualGuard","Feasibility Clinical Trial to Assess the Safety and Potential Effectiveness of Microlyte® DualGuard Wound Dressing on Surgically Created Partial-thickness Donor Site Wounds on Patients Requiring Split- Thickness Skin Grafting; the SAGGA Trial","SAGGA","Inclusion Criteria:\n\n1. Adult patients where creation of a donor site wound for any indication including chronic wound, burn wound, surgical\u002Ftraumatic wound, and tumor excision is indicated.\n2. Thigh donor site wound (DSW) location.\n3. At least 22 years of age.\n4. Ability to understand and provide a signed and dated informed consent form.\n5. Stated willingness to comply with all study procedures and availability for all visits for the duration of the study.\n6. All female subjects of childbearing potential (not surgically sterile or postmenopausal) and male subjects with female partners of childbearing potential must agree to use effective contraception (such as implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence, vasectomy or vasectomized partner) for the duration of the study (84 days).\n7. Fitzpatrick Skin Type (FST I-VI) assessment and documentation at baseline. Subjects of all FST categories (I-VI) are eligible, and the enrollment strategy will ensure that the full range of FST is represented in the study population (10% minimum enrollment in each FST sub-category).\n\nExclusion Criteria:\n\n1. DSW size of \\> 310 cm2\n2. Calculated glomerular filtration rate (GFR) \\\u003C60 ml\u002Fmin\n3. Hypocalcemia defined as serum corrected calcium of \\\u003C8.0 mg\u002Fdl\n4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 1.5 times the upper limit of normal (ULN).\n5. Serum Creatinine \\> 2.0 mg\u002FdL.\n6. Pregnant, lactating or nursing women.\n7. Unable to provide consent.\n8. Prior adverse reaction or known sensitivity to silver or gallium.\n9. Enrollment in another interventional trial using a systemic therapeutic within 30 days prior to enrollment for this study.\n10. Presumed impairment of wound healing as with prescription drugs or medical diagnoses that have potential to impair wound healing at the discretion of clinical investigator, e.g., cancer, transplant status, autoimmune disease, severe malnutrition, etc.\n11. Any diagnosis with concern for 30-Day mortality.\n12. Any condition that might impair the evaluation of subject safety or that in the investigator opinion would interfere with study requirements.","ALL","22 Years",{"count":116,"type":117},53,"ESTIMATED","INTERVENTIONAL",[120],"NA","The primary purpose of this research is to evaluate the safety and effectiveness of Microlyte® DualGuard wound dressing in the healing of partial thickness donor site wounds, also known as skin graft donor sites. This research will assess wound healing, the occurrence of infection, allergic reaction, pain, and itching while subjects are in the hospital and after discharge. Subjects will complete clinic visits through 12 weeks. This research will also assess the occurrence of donor site wound infection, pain and itching, and scarring at 12 weeks, assessed by subjects using the Patient and Observer Scar Assessment Scale (POSAS).",[123,124],"Wound Closure","Wound Care",[126,127,128],"Donor site wound","antimicrobial","wound dressing","NOT_YET_RECRUITING","2026-07-06",{"date":132,"type":133},"2026-07-10","ACTUAL",{"date":135,"type":117},"2026-08-30",{"date":137,"type":117},"2027-08",{"name":5,"class":6},3]