Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-02-24 @ 11:01 AM
Study NCT ID:
NCT02424357
Status:
COMPLETED
Last Update Posted:
2017-11-30
First Post:
2015-04-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Suture Contamination Rate in Adjustable Suture Strabismus Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hcapo@med.miami.edu', 'phone': '305-326-6555', 'title': 'Hilda Capo', 'organization': 'University of Miami'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '5% Povidone Iodine Ophthalmic Solution', 'description': 'patient received 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion', 'otherNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'no Povidone-iodine Ophthalmic Solution', 'description': 'patient received a routine antibiotic/steroid ointment to operated eye at surgery completion', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Suture Colonization Rate in Adjustable Suture Strabismus Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'units': 'sutures', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5% Povidone Iodine Ophthalmic Solution', 'description': 'patient received 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion'}, {'id': 'OG001', 'title': 'no Povidone-iodine Ophthalmic Solution', 'description': 'patient received a routine antibiotic/steroid ointment to operated eye at surgery completion'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 hours', 'description': '1 cm section of the suture proximal to the knot will be harvested and placed in a tube with 2 ml of trypticase soy broth (TSB).The TSB tubes will be monitored for growth of bacteria at 48 hours', 'unitOfMeasure': 'percentage sutures positive for bacteria', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sutures', 'denomUnitsSelected': 'sutures'}, {'type': 'SECONDARY', 'title': 'Reduction of Contamination Rate Using Post-operative 5% Povidone Iodine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'sutures', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'With or Without 5% Povidone Iodine Ophthalmic Solution', 'description': 'patients with and without 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '1.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 hours', 'description': 'Comparison of suture colonization rates with and without instillation of a drop of povidone-iodine at surgery completion', 'unitOfMeasure': 'relative risk', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sutures', 'denomUnitsSelected': 'sutures'}, {'type': 'SECONDARY', 'title': 'Identification of Bacterial Species Cultured From Suture Material', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'sutures', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'With or Without 5% Povidone Iodine Ophthalmic Solution', 'description': 'patients who received 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion and those that did not receive povidone-iodine'}], 'classes': [{'title': 'Staphylococcus epidermidis', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Staphylococcus lugdunensis', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Staphylococcus aureus', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Staphylococcus capitis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Staphylococcus hominis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Propionibacterium acnes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Staphylococcus cohnii', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Staphylococcus warneri', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Staphylococcus xylosus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Citrobacter koseri', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Lactococcus lactis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days plus 24 to 48 hours', 'description': 'The collected sutures will be monitored for bacterial growth for up to 7 days. When bacterial growth is observed, 1 mL of the solution will be inoculated on chocolate, MacConkey, and anaerobic blood agars and incubated for an additional 24 to 48 hours to identify organisms and quantify growth. In vitro susceptibility patterns will be determined.', 'unitOfMeasure': 'number of positive bacterial isolates', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sutures', 'denomUnitsSelected': 'sutures', 'populationDescription': 'All 65 participants were analyzed: 53 sutures had positive cultures (34 of the adjustable sutures and 19 of the control sutures). The relative risk between the two treatment arms indicated no difference in colonization rate, the bacterial species were not analyzed separately. Three of the sutures yielded 2 bacterial species.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '5% Povidone Iodine Ophthalmic Solution', 'description': 'patient received 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion'}, {'id': 'FG001', 'title': 'no Povidone-iodine Ophthalmic Solution', 'description': 'patient received a routine antibiotic/steroid ointment to operated eye at surgery completion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '5% Povidone Iodine Ophthalmic Solution', 'description': 'patient received 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion'}, {'id': 'BG001', 'title': 'no Povidone-iodine Ophthalmic Solution', 'description': 'patient received a routine antibiotic/steroid ointment to operated eye at surgery completion'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.5', 'spread': '16.8', 'groupId': 'BG000'}, {'value': '46.6', 'spread': '18.1', 'groupId': 'BG001'}, {'value': '47.6', 'spread': '17.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'The surgeon will be unaware of the randomization until the end of the surgery. All microbiology personnel and patients will be unaware of the interventional group'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-29', 'studyFirstSubmitDate': '2015-04-20', 'resultsFirstSubmitDate': '2017-07-14', 'studyFirstSubmitQcDate': '2015-04-22', 'lastUpdatePostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-29', 'studyFirstPostDateStruct': {'date': '2015-04-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Suture Colonization Rate in Adjustable Suture Strabismus Surgery', 'timeFrame': '48 hours', 'description': '1 cm section of the suture proximal to the knot will be harvested and placed in a tube with 2 ml of trypticase soy broth (TSB).The TSB tubes will be monitored for growth of bacteria at 48 hours'}], 'secondaryOutcomes': [{'measure': 'Reduction of Contamination Rate Using Post-operative 5% Povidone Iodine', 'timeFrame': '48 hours', 'description': 'Comparison of suture colonization rates with and without instillation of a drop of povidone-iodine at surgery completion'}, {'measure': 'Identification of Bacterial Species Cultured From Suture Material', 'timeFrame': '7 days plus 24 to 48 hours', 'description': 'The collected sutures will be monitored for bacterial growth for up to 7 days. When bacterial growth is observed, 1 mL of the solution will be inoculated on chocolate, MacConkey, and anaerobic blood agars and incubated for an additional 24 to 48 hours to identify organisms and quantify growth. In vitro susceptibility patterns will be determined.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Adjustable strabismus surgery', 'suture contamination', '5%povidone iodine'], 'conditions': ['Suture Strabismus Surgery']}, 'referencesModule': {'references': [{'pmid': '22909077', 'type': 'BACKGROUND', 'citation': 'Eustis HS, Rhodes A. Suture contamination in strabismus surgery. J Pediatr Ophthalmol Strabismus. 2012 Jul-Aug;49(4):206-9. doi: 10.3928/01913913-20110920-01.'}, {'pmid': '10532751', 'type': 'BACKGROUND', 'citation': 'Olitsky SE, Vilardo M, Awner S, Reynolds JD. Needle sterility during strabismus surgery. J AAPOS. 1998 Jun;2(3):151-2. doi: 10.1016/s1091-8531(98)90006-4.'}, {'pmid': '12765540', 'type': 'BACKGROUND', 'citation': 'Carothers TS, Coats DK, McCreery KM, Rossman SN, Wilson P, Wu TG, Paysse EA. Quantification of incidental needle and suture contamination during strabismus surgery. Binocul Vis Strabismus Q. 2003;18(2):75-9.'}, {'pmid': '7540363', 'type': 'BACKGROUND', 'citation': 'Apt L, Isenberg SJ, Yoshimori R, Chang A, Lam GC, Wachler B, Neumann D. The effect of povidone-iodine solution applied at the conclusion of ophthalmic surgery. Am J Ophthalmol. 1995 Jun;119(6):701-5. doi: 10.1016/s0002-9394(14)72773-4.'}, {'pmid': '27561000', 'type': 'DERIVED', 'citation': 'Rossetto JD, Suwannaraj S, Cavuoto KM, Spierer O, Miller D, McKeown CA, Capo H. Evaluation of Postoperative Povidone-Iodine in Adjustable Suture Strabismus Surgery to Reduce Suture Colonization: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Oct 1;134(10):1151-1155. doi: 10.1001/jamaophthalmol.2016.2926.'}]}, 'descriptionModule': {'briefSummary': '1. To establish the culture positivity rate in adjustable suture strabismus surgery\n2. To identify bacterial species and antibiotic susceptibility patterns of microorganisms cultured from suture material\n3. To compare suture contamination rates with techniques to reduce the suture contamination rate', 'detailedDescription': 'Patients will be randomized into 1 of 2 groups: those who received 1 drop of 5% povidone-iodine instilled directly over the sliding noose at surgery completion (group 1) and those who did not receive povidone-iodine at the end of the surgery (group 2).\n\nInstitutional standard surgical preparation will be performed in all patients with 5% povidone-iodine solution on the periocular skin and eyelid margins, followed by instillation of 1 drop of 5% povidone-iodine into the conjunctival cul-de-sac.\n\nAll operations will be performed using a sliding noose technique with a polyglactin 6-0 suture (Vicryl, Ethicon Inc). If a patient undergoes surgery on more than 1 muscle in the same eye, a 1-cm section of suture proximal to the knot will be collected from the nonadjustable suture as a control. The control suture will be placed in a tube with 2 mL of trypticase soy broth and agitated for 1 minute. At the end of surgery, patients in group 1 will receive a drop of povidone-iodine. A strip of neomycin sulfate, polymyxin B sulfate, and dexamethasone ophthalmic ointment will be then applied into the lower conjunctival fornix to patients in both groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All strabismus patients age ≥ 18 years scheduled for strabismus surgery with adjustable sutures at the Bascom Palmer Eye Institute will be invited to participate.\n\nExclusion Criteria:\n\n* Patient who has a history of allergy to povidone-iodine.\n* Disorders affecting immune function.\n* Patient who is unwilling to participate in the study'}, 'identificationModule': {'nctId': 'NCT02424357', 'briefTitle': 'Suture Contamination Rate in Adjustable Suture Strabismus Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Suture Contamination Rate in Adjustable Suture Strabismus Surgery', 'orgStudyIdInfo': {'id': '20150111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5% povidone iodine ophthalmic solution', 'description': 'patient received 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion', 'interventionNames': ['Drug: 5%povidone iodine ophthalmic solution', 'Drug: routine post-operative ophthalmic ointment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'no povidone-iodine ophthalmic solution', 'description': 'patient received a routine antibiotic/steroid ointment to operated eye at surgery completion', 'interventionNames': ['Drug: routine post-operative ophthalmic ointment']}], 'interventions': [{'name': '5%povidone iodine ophthalmic solution', 'type': 'DRUG', 'otherNames': ['5%Betadine ophthalmic drop'], 'description': 'one drop of 5% povidone iodine instilled into the conjunctival fornix.', 'armGroupLabels': ['5% povidone iodine ophthalmic solution']}, {'name': 'routine post-operative ophthalmic ointment', 'type': 'DRUG', 'description': 'patient received a routine antibiotic/steroid ointment to operated eye at surgery completion', 'armGroupLabels': ['5% povidone iodine ophthalmic solution', 'no povidone-iodine ophthalmic solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Bascom Palmer Eye Institute, University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Hilda Capo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bascom Palmer Eye Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Clinical', 'investigatorFullName': 'Hilda Capo', 'investigatorAffiliation': 'University of Miami'}}}}