Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-04 @ 9:27 PM
Study NCT ID:
NCT04039750
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-23
First Post:
2019-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013396', 'term': 'Suction'}, {'id': 'D002981', 'term': 'Clindamycin'}, {'id': 'D005839', 'term': 'Gentamicins'}], 'ancestors': [{'id': 'D004322', 'term': 'Drainage'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008034', 'term': 'Lincomycin'}, {'id': 'D055231', 'term': 'Lincosamides'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000617', 'term': 'Aminoglycosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'there is no masking after randomization'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized into 1 of 2 groups. Group "A" will be Antibiotic Irrigation with suction and Group "B" will be Suction Alone.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-20', 'studyFirstSubmitDate': '2019-07-26', 'studyFirstSubmitQcDate': '2019-07-29', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'wound complications', 'timeFrame': '30 days', 'description': 'The overall objective is to change the postoperative wound complications and IAA after laparoscopic appendectomy for perforated appendicitis in pediatric patients. The outcome will be measured by tracking any wound complications that these patients have and comparing the incidence between treatment arms'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perforated Appendicitis']}, 'descriptionModule': {'briefSummary': 'The proposed study will investigate whether antibiotic irrigation using a gentamicin/clindamycin solution during laparoscopic appendectomy is superior in preventing postoperative wound infections and IAA in perforated appendicitis compared to suction without irrigation. This will be the first prospective study to compare these two options in pediatric PA.', 'detailedDescription': 'This study is for pediatric patients who are having an appendectomy and have a perforated appendix. The purpose of this study is to see whether antibiotic irrigation using gentamicin, clindamycin and suction during the surgery works better when compared to suction alone when cleaning the stomach cavity.\n\nArm A patients will have their abdomen irrigated with the antibiotics, gentamycin and clindamycin, and then the wound will be suctioned out. Arm B patients will not have the antibiotic irrigation but will have their wound suctioned.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, age 18 years or younger\n2. Scheduled to undergo laparoscopic appendectomy\n3. Preoperative or intra-operative diagnosis of perforated appendicitis (PA).\n4. Willingness to undergo treatments, provide written informed consent, and participate in follow-up.\n\nExclusion Criteria:\n\n1. Male or female older than 18 years of age\n2. Declined to undergo laparoscopic appendectomy\n3. Not willing to provide written informed consent or undergo randomization of treatment\n4. Pregnancy'}, 'identificationModule': {'nctId': 'NCT04039750', 'acronym': 'PA protocol', 'briefTitle': 'Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis', 'organization': {'class': 'OTHER', 'fullName': 'Prisma Health-Upstate'}, 'officialTitle': 'Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis', 'orgStudyIdInfo': {'id': 'Pro00088360'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Antibiotic irrigation with suction', 'description': 'Group A: You will receive antibiotic irrigation with suction if a PA is found during surgery', 'interventionNames': ['Drug: antibiotic rinse with suction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'suction only', 'description': 'Group B: You will receive suction alone if a PA is found during surgery', 'interventionNames': ['Procedure: suction only']}], 'interventions': [{'name': 'antibiotic rinse with suction', 'type': 'DRUG', 'otherNames': ['Clindamycin, gentamycin'], 'description': 'antibiotic rinse with suction', 'armGroupLabels': ['Antibiotic irrigation with suction']}, {'name': 'suction only', 'type': 'PROCEDURE', 'description': 'no irrigation, suction only', 'armGroupLabels': ['suction only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health - Upstate', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}], 'overallOfficials': [{'name': 'Robert Gates, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prisma Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prisma Health-Upstate', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}