Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-27 @ 11:03 PM
Study NCT ID:
NCT05093894
Status:
WITHDRAWN
Last Update Posted:
2022-10-10
First Post:
2021-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microlyte in Prevention of SSI After Open Ventral Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006555', 'term': 'Hernia, Ventral'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI decided not to continue study due to no funding.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-06', 'studyFirstSubmitDate': '2021-10-13', 'studyFirstSubmitQcDate': '2021-10-13', 'lastUpdatePostDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of SSI following clean OVHR with and without Microlyte.', 'timeFrame': '90 days', 'description': 'SSI, which is the primary outcome that will be measured for the study will be as an infection of the skin or subcutaneous tissues as clinically determined by the physician caring for the patient'}], 'secondaryOutcomes': [{'measure': 'Rate of other wound complications, including superficial wound breakdown, seroma formation, and mesh infection, with/without Microlyte.', 'timeFrame': '90 days', 'description': 'Other wound complications will be defined based on a combination of clinical assessment and review of postoperative notes and imaging'}, {'measure': 'Rate of short-term readmissions with and without Microlyte', 'timeFrame': '30-days', 'description': 'Short-term readmissions'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Ventral Hernia']}, 'descriptionModule': {'briefSummary': 'Participants who are scheduled to have open ventral hernia repair (OVHR) will be asked to take part in this study.\n\nThe purpose of this study is to find out if placing Microlyte (which is a dissolvable sheet coated in silver) on the surgical incision is better than placing nothing on the surgical incision when it comes to decreasing the chance of surgical site infections.\n\nThe study device has been cleared by the Food and Drug Administration (FDA) for use on surgical incisions.\n\nA total of 280 participants will be included in the study.\n\nParticipation will last for about 90 days.', 'detailedDescription': 'The aim of our study is to assess the impact of Microlyte-AG® (Imbed Biosciences, Fitchburg, WI), a silver-coated bioabsorbable matrix, on surgical site infection (SSI) on patients undergoing clean open ventral hernia repair (OVHR) at Carolinas Medical Center/Atrium Health (Charlotte, NC), Prisma Health-Upstate (Greenville, SC), and Mission Health/HCA Healthcare (Asheville, NC).\n\nThose who agree to participate in the study will undergo the following:\n\nInformation will be collected, including demographics, past medical and surgical history, and hospital outcomes.\n\nOn the day of surgery, participants will be "randomized" into one of the study groups listed below.\n\n* Group 1: The study device will be cut into strips and placed in the surgical incision\n* Group 2: Nothing will be placed in the surgical incision\n\nFor both groups, the surgical incision will then be closed with absorbable sutures, which is the usual treatment.\n\nParticipants will be seen by the study doctor 30 and 90 days after surgery for a checkup. At the 30-day visit, participants will have a physical examination, and the study doctor will check to see if any complications have happened since the last visit. The 90-day follow-up visit can be done in person or over the telephone and will be done to check and see if there have been any problems with the healing of the surgical incision.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women over 18 years of age\n* Patients undergoing open hernia repair with retromuscular or preperitoneal placement of polypropylene mesh in clean (Class I) operative fields, and who are candidates for complete skin closure\n* Capable and willing to attend the scheduled postoperative visits\n* Signed ICF for study enrollment\n\nExclusion Criteria:\n\n* Prisoners\n* Minimally invasive repairs (laparoscopy, robotics)\n* CDC Wound Class II-IV\n* Irrigation of the wound or peritoneal cavity with antibiotic or antimicrobial fluid\n* Inability to completely close the midline fascia\n* Mesh placed as a bridge, onlay, or intraperitoneal position to the fascia\n* Skin left open or packed at the time of the index operation\n* Use of wound wicks at the time of the index operation\n* Use of an investigational product within the preceding 60 days\n* Allergy to silver'}, 'identificationModule': {'nctId': 'NCT05093894', 'briefTitle': 'Microlyte in Prevention of SSI After Open Ventral Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Prisma Health-Upstate'}, 'officialTitle': 'A Prospective, Multicenter Randomized Study of Microlyte - AG Bioresorbable Matrix in the Prevention of Surgical Site Infection After Open Ventral Hernia Repair', 'orgStudyIdInfo': {'id': 'Pro00115720'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1: Microlyte will be cut into strips and placed on the surgical incision', 'description': 'Microlyte will be cut into strips and placed on the surgical incision', 'interventionNames': ['Device: Group 1']}, {'type': 'NO_INTERVENTION', 'label': 'Group 2: Nothing will be placed on the surgical incision', 'description': 'Nothing will be placed on the surgical incision'}], 'interventions': [{'name': 'Group 1', 'type': 'DEVICE', 'description': 'Microlyte will be cut into strips and placed on the subcutaneous space', 'armGroupLabels': ['Group 1: Microlyte will be cut into strips and placed on the surgical incision']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Mission Hospital/HCA Healthcare', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Medical Center/Atrium Health', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}], 'overallOfficials': [{'name': 'Alfredo M Carbonell, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prisma Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prisma Health-Upstate', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, {'name': 'Kendall Healthcare Group, Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}