Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT01449669
Status:
COMPLETED
Last Update Posted:
2014-02-10
First Post:
2011-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Site Infection Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-07', 'studyFirstSubmitDate': '2011-09-26', 'studyFirstSubmitQcDate': '2011-10-06', 'lastUpdatePostDateStruct': {'date': '2014-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics of Cefazolin', 'timeFrame': 'predose, .08,.25, .5, 1, 1.5, 2, 3, 4 hours and post dose.', 'description': 'Composite (or Profile) of Pharmacokinetics'}], 'secondaryOutcomes': [{'measure': 'Investigate the relationship between cefazolin concentrations in the plasma and those at the level of IF of skeletal muscle', 'timeFrame': 'One Year', 'description': '* Investigate the effects of CPB, DHCA, and MUF on tissue distribution of cefazolin\n* Determine the concentration of cefazolin in IF of skeletal muscle at different stages of cardiac surgery and compare these values to concentrations of cefazolin needed to be effective against common bacterial organisms causing SSIs\n* Investigate the relationship between cefazolin concentrations in the plasma and those at the level of IF of skeletal muscle.\n* Assess the safety of the use of microdialysis method during pediatric cardiac surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pharmacokinetics', 'cefazolin', 'microdialysis sampling', 'interstitial fluid', 'skeletal muscle', 'plasma', 'children'], 'conditions': ['Cava-pulmonary Anastomosis']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Centers for Disease Control and Prevention (CDC). Division of Healthcare Quality Promotion (DHPQ). Estimates of Healthcare-Associated Infections. March 12, 2010. Available at: http://www.cdc.gov/ncidod/dhqp/hai.html. Accessed August 3, 2010.'}, {'pmid': '18840089', 'type': 'BACKGROUND', 'citation': 'Anderson DJ, Kaye KS, Classen D, Arias KM, Podgorny K, Burstin H, Calfee DP, Coffin SE, Dubberke ER, Fraser V, Gerding DN, Griffin FA, Gross P, Klompas M, Lo E, Marschall J, Mermel LA, Nicolle L, Pegues DA, Perl TM, Saint S, Salgado CD, Weinstein RA, Wise R, Yokoe DS. Strategies to prevent surgical site infections in acute care hospitals. Infect Control Hosp Epidemiol. 2008 Oct;29 Suppl 1:S51-61. doi: 10.1086/591064. No abstract available.'}, {'pmid': '17627217', 'type': 'BACKGROUND', 'citation': 'Sparling KW, Ryckman FC, Schoettker PJ, Byczkowski TL, Helpling A, Mandel K, Panchanathan A, Kotagal UR. Financial impact of failing to prevent surgical site infections. Qual Manag Health Care. 2007 Jul-Sep;16(3):219-25. doi: 10.1097/01.QMH.0000281058.99929.ea.'}, {'pmid': '20494036', 'type': 'BACKGROUND', 'citation': 'Costello JM, Graham DA, Morrow DF, Morrow J, Potter-Bynoe G, Sandora TJ, Pigula FA, Laussen PC. Risk factors for surgical site infection after cardiac surgery in children. Ann Thorac Surg. 2010 Jun;89(6):1833-41; discussion 1841-2. doi: 10.1016/j.athoracsur.2009.08.081.'}, {'pmid': '18951662', 'type': 'BACKGROUND', 'citation': 'Ben-Ami E, Levy I, Katz J, Dagan O, Shalit I. Risk factors for sternal wound infection in children undergoing cardiac surgery: a case-control study. J Hosp Infect. 2008 Dec;70(4):335-40. doi: 10.1016/j.jhin.2008.08.010. Epub 2008 Oct 31.'}, {'pmid': '18171193', 'type': 'BACKGROUND', 'citation': 'Holzmann-Pazgal G, Hopkins-Broyles D, Recktenwald A, Hohrein M, Kieffer P, Huddleston C, Anshuman S, Fraser V. Case-control study of pediatric cardiothoracic surgical site infections. Infect Control Hosp Epidemiol. 2008 Jan;29(1):76-9. doi: 10.1086/524323.'}, {'pmid': '17596804', 'type': 'BACKGROUND', 'citation': 'Kagen J, Lautenbach E, Bilker WB, Matro J, Bell LM, Dominguez TE, Gaynor JW, Shah SS. Risk factors for mediastinitis following median sternotomy in children. Pediatr Infect Dis J. 2007 Jul;26(7):613-8. doi: 10.1097/INF.0b013e31806166bb.'}, {'pmid': '15014298', 'type': 'BACKGROUND', 'citation': 'Allpress AL, Rosenthal GL, Goodrich KM, Lupinetti FM, Zerr DM. Risk factors for surgical site infections after pediatric cardiovascular surgery. Pediatr Infect Dis J. 2004 Mar;23(3):231-4. doi: 10.1097/01.inf.0000114904.21616.ba.'}, {'pmid': '15525914', 'type': 'BACKGROUND', 'citation': 'Nateghian A, Taylor G, Robinson JL. Risk factors for surgical site infections following open-heart surgery in a Canadian pediatric population. Am J Infect Control. 2004 Nov;32(7):397-401. doi: 10.1016/j.ajic.2004.03.004.'}, {'pmid': '11055604', 'type': 'BACKGROUND', 'citation': 'Mehta PA, Cunningham CK, Colella CB, Alferis G, Weiner LB. Risk factors for sternal wound and other infections in pediatric cardiac surgery patients. Pediatr Infect Dis J. 2000 Oct;19(10):1000-4. doi: 10.1097/00006454-200010000-00012.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the pharmacokinetics of cefazolin using both plasma and microdialysate sampling methods in children with single ventricle physiology undergoing their second palliation procedure. This will provide data to determine if the current standard dosing regimen of cefazolin is adequate to achieve and maintain tissue concentrations greater than the minimum inhibitory concentrations (MIC) for common post-surgical pathogens that cause Surgical Site Infections (SSIs).', 'detailedDescription': 'This study aims to sample interstitial fluid (IF) of infants undergoing superior cava-pulmonary anastomosis (either Glenn or Hemi-Fontan) cardiac surgical procedures who receive cefazolin as their surgical prophylactic antibiotic. Cefazolin concentrations will then be determined in both microdialysate and plasma samples and used to define the pharmacokinetics of cefazolin at the tissue level and compare that to plasma pharmacokinetics. In addition, the data gathered will be used to assess how cardiopulmonary bypass (CPB), deep hypothermic cardiac arrest (DHCA), and modified ultrafiltration (MUF) affect tissue penetration of the prophylactically administered cefazolin.\n\nThe study involves the use of microdialysis (MD) and plasma sampling methods to determine the pharmacokinetic properties of cefazolin when used as a prophylactic antibiotic during the second palliation procedure (superior vena cava-pulmonary anastomosis) for infants with single ventricle physiology. This requires the use of microdialysis (MD) catheters inserted into the left deltoid muscle in eligible subjects after the induction of general anesthesia as well as collection of microdialysate and blood samples throughout the duration of the procedure. Cefazolin will be administered as standard of care. Cefazolin concentrations in the collected samples will be measured via a validated high-performance liquid chromatography (HPLC) and mass spectrometry assay. Pharmacokinetic analyses will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '3 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Males or females with single ventricle physiology undergoing their second palliation procedure (typically performed between 3-6 months of age)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females with single ventricle physiology undergoing their second palliation procedure (typically performed between 3-6 months of age)\n* Use of cefazolin as the prophylactic antibiotic during the operation\n* Written informed consent provided by the parent or legal guardian\n\nExclusion Criteria:\n\n* Use of prophylactic antibiotic other than cefazolin during the operation\n* Anatomic or other abnormalities of the upper arm that would preclude insertion of a microdialysis catheter\n* Known renal or hepatic function'}, 'identificationModule': {'nctId': 'NCT01449669', 'acronym': 'SSI', 'briefTitle': 'Surgical Site Infection Study', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'Skeletal Muscle and Plasma Concentrations of Cefazolin During Pediatric Cardiac Surgery Utilizing Cardiopulmonary Bypass, Deep Hypothermic Cardiac Arrest, and Modified Ultrafiltration', 'orgStudyIdInfo': {'id': '11-007976'}, 'secondaryIdInfos': [{'id': 'PSSIMD'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Todd Kilbaugh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}