Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-27 @ 5:28 AM
Study NCT ID:
NCT01606657
Status:
COMPLETED
Last Update Posted:
2017-05-03
First Post:
2012-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Irrigation Versus no Irrigation for Cutaneous Abscess
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000038', 'term': 'Abscess'}], 'ancestors': [{'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007507', 'term': 'Therapeutic Irrigation'}], 'ancestors': [{'id': 'D006875', 'term': 'Hydrotherapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-01', 'studyFirstSubmitDate': '2012-05-21', 'studyFirstSubmitQcDate': '2012-05-23', 'lastUpdatePostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients needing further treatment after irrigation for I&D', 'timeFrame': '7 day phone follow-up', 'description': 'Percentage of patients needing further treatment i. Further treatment defined as\n\n1. Repeat I\\&D\n2. Addition of an antibiotic (as new or to a pre-existing antibiotic)\n3. Admission to hospital for cutaneous abscess-related problem\n\n 1. Abscess\n 2. Cellulitis\n 3. Septic arthritis\n 4. Sepsis'}], 'secondaryOutcomes': [{'measure': 'VAS is correlated with decreased pain after I&D', 'timeFrame': 'two years', 'description': '1\\) VAS post procedure pain score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['I&D', 'Abscess', 'Irrigation', 'Cutaneous Abscess'], 'conditions': ['Cutaneous Abscess']}, 'referencesModule': {'references': [{'pmid': '19388915', 'type': 'BACKGROUND', 'citation': "O'Malley GF, Dominici P, Giraldo P, Aguilera E, Verma M, Lares C, Burger P, Williams E. Routine packing of simple cutaneous abscesses is painful and probably unnecessary. Acad Emerg Med. 2009 May;16(5):470-3. doi: 10.1111/j.1553-2712.2009.00409.x. Epub 2009 Apr 10."}, {'pmid': '9137156', 'type': 'BACKGROUND', 'citation': 'Abraham N, Doudle M, Carson P. Open versus closed surgical treatment of abscesses: a controlled clinical trial. Aust N Z J Surg. 1997 Apr;67(4):173-6. doi: 10.1111/j.1445-2197.1997.tb01934.x.'}, {'pmid': '3880635', 'type': 'BACKGROUND', 'citation': 'Llera JL, Levy RC. Treatment of cutaneous abscess: a double-blind clinical study. Ann Emerg Med. 1985 Jan;14(1):15-9. doi: 10.1016/s0196-0644(85)80727-7.'}, {'pmid': '3881155', 'type': 'BACKGROUND', 'citation': 'Stewart MP, Laing MR, Krukowski ZH. Treatment of acute abscesses by incision, curettage and primary suture without antibiotics: a controlled clinical trial. Br J Surg. 1985 Jan;72(1):66-7. doi: 10.1002/bjs.1800720125.'}]}, 'descriptionModule': {'briefSummary': 'In this study, the investigators are trying to find out if washing out the abscess (pocket of pus) with fluid will help, instead of only taking out the pus. Your care will be the same as usual, except that you will be selected randomly to have your abscess washed out with fluid, or not.', 'detailedDescription': 'Irrigation of the abscess cavity is commonly described as part of the procedure of incision and drainage of cutaneous abscesses (1-4). Despite this, there are no randomized controlled trials that demonstrate the benefit of irrigation in treatment of these abscesses. Potential disadvantages of irrigation include increased procedural time, pain, increased cost with sterile irrigation solutions and materials to capture the irrigation effluent, and increased risk of microbiologic contamination of the surrounding area. The goal of this study is to examine patients undergoing incision and drainage of cutaneous abscesses to determine if irrigation of the abscess cavity affects the need for further interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All patients 18 years of age and above\n2. Patients that require a cutaneous abscess incision and drainage\n\nExclusion Criteria:\n\n1. Unable to return for 48-hour followup.\n2. Patients being admitted to the hospital or going to the operating room for incision and drainage\n3. Pregnant patients\n4. Prisoners'}, 'identificationModule': {'nctId': 'NCT01606657', 'briefTitle': 'Irrigation Versus no Irrigation for Cutaneous Abscess', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Is Routine Irrigation of Cutaneous Abscesses Necessary?', 'orgStudyIdInfo': {'id': '10012010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Irrigation', 'description': 'THE PATIENT IS TO HAVE IRRIGATION OF THE ABSCESS WITH NORMAL SALINE AS PART OF THE I\\&D PROCEDURE', 'interventionNames': ['Procedure: Irrigation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No Irrigation', 'description': 'THE PATIENT IS NOT TO HAVE IRRIGATION OF THE ABSCESS AS PART OF THE I\\&D PROCEDURE', 'interventionNames': ['Other: No Irrigation']}], 'interventions': [{'name': 'Irrigation', 'type': 'PROCEDURE', 'description': 'The patient will receive irrigation as a part of their wound care', 'armGroupLabels': ['Irrigation']}, {'name': 'No Irrigation', 'type': 'OTHER', 'description': 'The patient will not receive irrigation as part of their wound care', 'armGroupLabels': ['No Irrigation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93721', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Community Regional Trauma and Burn Center', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}], 'overallOfficials': [{'name': 'Brian Chinnock, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSF, Community Regional Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Clinical Professor of Emergency Medicine, Director of Coding/Reimbursement', 'investigatorFullName': 'Brian Chinnock', 'investigatorAffiliation': 'University of California, San Francisco'}}}}