[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658543":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":32,"studyPopulation":32,"armGroups":39,"interventions":46,"overallOfficials":55,"centralContacts":59,"locations":64,"responsibleParty":87,"collaborators":89,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":32,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":32,"enrollmentInfo":102,"targetDuration":32,"studyType":105,"phases":106,"briefSummary":107,"conditions":108,"keywords":112,"overallStatus":116,"whyStopped":32,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Rate of post-operative seroma, hematoma formation, or wound dehiscence within 6 weeks of procedure","Clinical assessment of seroma formation will be conducted by the investigator through evaluation of the surgical site for the presence of swelling and\u002For fluid wave upon exam. Clinical assessment of hematoma formation and wound dehiscence will be conducted by the investigator through evaluation of the surgical site for the presence of swelling, discoloration, and firmness to the touch upon palpitation. Wound dehiscence is defined as separation of the margins of the closed surgical incision made in the skin, with or without exposure\u002Fprotrusion of underlying tissue.","At time of procedure to 6 weeks after procedure (total estimated time: 6 weeks)",[14,18,21,24,28],{"measure":15,"description":16,"timeFrame":17},"Rate of post-operative infection","Post-operative infection will be assessed via the occurrence of physiological symptoms including fever, pain, swelling, erythema, or seroma via clinical assessment. Post-operative infection will be summarized as absolute counts and as descriptive proportions along with corresponding 95% confidence intervals.","At time of procedure until 3 months after procedure (total estimated time: 3 months)",{"measure":19,"description":20,"timeFrame":17},"Rate of post-operative wound dehiscence within 3 months of procedure","Post-operative wound dehiscence will be determined via ultrasound and clinical assessment of the surgical site. Wound dehiscence is defined as separation of the margins of the closed surgical incision made in the skin, with or without exposure\u002Fprotrusion of underlying tissue. Wound dehiscence will be summarized as absolute counts and as descriptive proportions along with corresponding 95% confidence intervals.",{"measure":22,"description":23,"timeFrame":17},"Rate of unplanned re-operation at the donor site","Incidence of unplanned reoperation of the donor site from the initial surgical procedure will be assessed as they occur and reported as absolute counts and descriptive proportions along with corresponding 95% confidence intervals.",{"measure":25,"description":26,"timeFrame":27},"Drain output in cc","Total drain output in cc will be reported as means with standard deviation if data is normally distributed and as medians with interquartile and absolute ranges if skewed.","At time of drain removal (total estimated time: 1-4 weeks)",{"measure":29,"description":30,"timeFrame":31},"Time of transfer procedure to drain removal as assessed in days","Drains will be removed when output is less than 30 cc over 24 hours. Time of transfer procedure to drain removal in days will be reported as means with standard deviation if data is normally distributed and as medians with interquartile and absolute ranges if skewed.","At time of procedure until time of drain removal (total estimated time 1-4 weeks)",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":32,"primaryPurpose":36,"observationalModel":32,"timePerspective":32,"maskingInfo":37},"NA","SINGLE_GROUP","SUPPORTIVE_CARE",{"masking":38,"maskingDescription":32,"whoMasked":32},"NONE",[40],{"label":41,"type":42,"description":43,"interventionNames":44},"Restrata® application","EXPERIMENTAL","Patients undergoing standard of care deep inferior epigastric perforator (DIEP) or abdominal wall free tissue transfer procedure will have Restrata® sheets applied to the abdominal wall donor site following flap harvest. Patients will be followed for 12 months to assess outcomes.",[45],"Device: Restrata®",[47],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"DEVICE","Restrata®","Restrata® is prepared in 5 x 7cm sheets and will be administered to the abdominal wall donor site following the flab harvest.",[41],[53,54],"Synthetic Electrospun Fiber Matrix","SEFM",[56],{"name":57,"affiliation":5,"role":58},"Justin Sacks, MD, MBA, FACS","PRINCIPAL_INVESTIGATOR",[60],{"name":57,"role":61,"phone":62,"phoneExt":32,"email":63},"CONTACT","314-454-4894","jmsacks@wustl.edu",[65],{"facility":5,"status":32,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"St Louis","Missouri","63110","United States","US",{"type":72,"coordinates":73},"Point",[74,75],-90.19789,38.62727,{"lat":75,"lon":74},[78,79,80,83,85],{"name":57,"role":61,"phone":62,"phoneExt":32,"email":63},{"name":57,"role":58,"phone":32,"phoneExt":32,"email":32},{"name":81,"role":82,"phone":32,"phoneExt":32,"email":32},"William Zhu, MD","SUB_INVESTIGATOR",{"name":84,"role":82,"phone":32,"phoneExt":32,"email":32},"Terence Myckatyn, MD",{"name":86,"role":82,"phone":32,"phoneExt":32,"email":32},"Gary Skolnick, MBA",{"type":88,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[90],{"name":91,"class":92},"Acera Surgical, Inc.","INDUSTRY","100658543","synthetic-electrospun-fiber-matrix-in-abdominal-wall-donor-sites-for-breast-reconstruction-100658543",false,"NCT07851415","Synthetic Electrospun Fiber Matrix in Abdominal Wall Donor Sites for Breast Reconstruction","A Prospective Pilot Study of Synthetic Electrospun Fiber Matrix in Abdominal Wall Donor Sites for Breast Reconstruction","Inclusion Criteria:\n\n* Scheduled for DIEP or abdominal wall autologous free tissue transfer procedure.\n* At least 18 years of age.\n* Karnofsky performance status ≤ 80%\n* Ability to understand and willingness to sign an IRB approved written informed consent document.\n\nExclusion Criteria:\n\n* Current smoker.\n* Body mass index \\> 39.9.\n* Received systemic chemotherapy within 4 weeks prior to the scheduled DIEP or abdominal wall autologous free tissue transfer procedure.\n* Uncontrolled diabetes mellitus determined by the investigator.\n\n  \\*Note: if there is documentation of HgbA1c \\> 12% within 3 months of the scheduled DIEP or abdominal wall autologous free tissue transfer procedure, it will need to be reviewed by the PI to determine the patient's clinical situation and eligibility.\n* Pregnant.\n* Currently receiving any investigational agents.\n* Known sensitivity to resorbable sutures (polyglactin 910, polydioxanone).","ALL","18 Years",{"count":103,"type":104},20,"ESTIMATED","INTERVENTIONAL",[34],"This prospective single-arm pilot study will evaluate the application of meshed 5 × 7 cm Restrata® sheets to the abdominal wall donor site following deep inferior epigastric perforator (DIEP) or abdominal wall autologous free tissue transfer in 20 eligible patients.",[109,110,111],"Breast Reconstruction","Deep Inferior Epigastric Perforator","Breast Reconstruction After Mastectomy",[113,114,115],"Breast reconstruction","DIEP (Deep Inferior Epigastric Perforators)","Microvascular","NOT_YET_RECRUITING","2026-09-24",{"date":119,"type":120},"2026-10-01","ACTUAL",{"date":122,"type":104},"2026-11-30",{"date":124,"type":104},"2028-02-29",{"name":5,"class":6},1]