Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-02-26 @ 12:37 AM
Study NCT ID:
NCT03703661
Status:
UNKNOWN
Last Update Posted:
2018-10-17
First Post:
2018-10-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Needle-Aspirated Compression Dressing Following Ostomy Reversal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 122}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2017-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-12', 'studyFirstSubmitDate': '2018-10-09', 'studyFirstSubmitQcDate': '2018-10-09', 'lastUpdatePostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Site Infection', 'timeFrame': '30 days post procedure', 'description': 'Surgical Site Infection'}], 'secondaryOutcomes': [{'measure': 'Rate of Wound Closure', 'timeFrame': '3 weeks post procedure and 12 weeks post procedure', 'description': 'rate of wound closure at 3 weeks post procedure and 12 weeks post procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['negative pressure wound therapy'], 'conditions': ['Colostomy Stoma', 'Ileostomy - Stoma', 'Surgical Site Infection', 'Wound Complication']}, 'descriptionModule': {'briefSummary': 'Negative pressure wound dressings have been studied and shown to have applications in decreasing rates of surgical wound infections. This study studies the effect of a low cost needle-aspirated negative pressure compression dressing on rates of wound infection at prior ostomy site in patients undergoing ostomy reversal surgery.', 'detailedDescription': 'Negative Pressure Wound Therapy (NPWT) will be studied in colorectal surgery patients undergoing ostomy reversal surgery. The immediate goal is to compare primary wound closure against primary closure with needle-aspirated compression dressing, and determine if risk of potential ostomy site wound infections is decreased. The investigators would also like to evaluate if this compression dressing can increase prevalence of complete wound closure by 12 weeks (last planned clinic visit). NPWT using a continuous suction device was shown to decrease surgical site infection (SSI) at ostomy reversal sites undergoing primary closure. There is a lack of published literature studying NPWT dressings without an associated suction device. The investigators will be using a low-cost simple needle-aspirated suction technique to provide negative pressure under a tegaderm/gauze dressing, at the time of placement. Patients will be consented and randomized into a negative pressure group, or a control group consisting of the same dressing under normal pressure. All adult patients undergoing ostomy reversal surgery who consent to the study will be included. Exclusion criteria include prior recurrent skin infections, prior stoma-site infection, or large parastomal hernia. Patients in the negative pressure group will have the pressure under the dressing measured immediately prior to removal on post-operative day 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* at least 18 years of age\n* presence of a loop or end colostomy or ileostomy\n* consenting to study and to ostomy reversal\n\nExclusion Criteria:\n\n* altered mental status or patients unable to sign the informed consent form\n* vulnerable patient populations such as prison and ward patients\n* patients who are discovered before or during surgery as unable to undergo placement of compression dressing will be excluded.\n* Patients with visible protrusion/evidence of large parastomal hernia\n* history of recurrent skin \\& soft tissue infections\n* history of previous stoma site infection or complications\n* patients with extensive comorbidities (such as cancer involving stoma site, uncontrolled diabetes, etc), Crohn's patients and abdominal wall fistula patients\n* patients in who primary closure of wound is deemed inappropriate by the operating surgeon, requiring a different method of stoma site wound management"}, 'identificationModule': {'nctId': 'NCT03703661', 'briefTitle': 'Needle-Aspirated Compression Dressing Following Ostomy Reversal', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Can a Low Cost, Simple Needle-Aspirated Compression Dressing Reduce Surgical Site Infection Rates of Primarily Closed Ileostomy and Colostomy Reversal Wounds?', 'orgStudyIdInfo': {'id': 'HS-16-00812'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control', 'description': 'primary closure with gauze and adhesive/occlusive dressing', 'interventionNames': ['Procedure: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Negative Pressure', 'description': 'primary closure with gauze and adhesive/occlusive dressing under negative pressure', 'interventionNames': ['Procedure: Needle-Aspirated Negative Pressure Dressing']}], 'interventions': [{'name': 'Needle-Aspirated Negative Pressure Dressing', 'type': 'PROCEDURE', 'description': 'dressing consisting of Needle-Aspirated Negative Pressure dressing with gauze and adhesive/occlusive dressing, placed over wound after primary closure', 'armGroupLabels': ['Negative Pressure']}, {'name': 'Control', 'type': 'PROCEDURE', 'description': 'dressing consisting of gauze and adhesive/occlusive dressing, placed over wound after primary closure', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Sang W Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be made available outside the study group.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Clinical Surgery, Chief, Division of Colorectal Surgery', 'investigatorFullName': 'Sang Won Lee', 'investigatorAffiliation': 'University of Southern California'}}}}