Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-04 @ 6:17 AM
Study NCT ID:
NCT06506032
Status:
COMPLETED
Last Update Posted:
2024-07-22
First Post:
2024-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vancomycin and Negative Pressure Therapy for Post-sternotomy Deep Sternal Wound Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum and exudate samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-18', 'studyFirstSubmitDate': '2024-06-28', 'studyFirstSubmitQcDate': '2024-07-10', 'lastUpdatePostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vancomycin penetration into exudate', 'timeFrame': 'repeated measurements for the total of 72 hours', 'description': 'To determine the vancomycin penetration into the wound during NPWT, the investigators compared the vancomycin total (bound + unbound) average exudate concentration to the vancomycin total (bound + unbound) average serum concentration on the first study day. The same calculation was used to determine the penetration ratio for free (unbound) vancomycin concentrations on the first study day.\n\nFor samples from three consecutive days, the investigators compared the vancomycin total (bound + unbound) through exudate concentrations with the vancomycin total (bound + unbound) through serum concentrations. The same calculation was used to determine the penetration ratio for free (unbound) vancomycin concentrations on three consecutive days.'}], 'secondaryOutcomes': [{'measure': 'Identification of pre-, intra-, and postoperative risk factors for deep sternal wound infection (DSWI) development', 'timeFrame': '3 days', 'description': 'The investigators will identify independent risk factors for DSWI by comparing patients with and without DSWI after cardiac surgery.'}, {'measure': 'Recurrence of DSWI', 'timeFrame': '1- year follow-up', 'description': 'The investigators will assess the recurrence of DSWI in the study subjects.'}, {'measure': 'Determination of mortality', 'timeFrame': '1- year follow-up', 'description': 'The investigators will assess the in-hospital, 90-day, and all-cause mortality in the study subjects.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exudate', 'Deep Sternal Wound Infection', 'Negative Pressure Wound Therapy', 'Open-Heart Surgery', 'Vancomycin', 'Wound Penetration'], 'conditions': ['Post-Sternotomy Deep Sternal Wound Infection']}, 'referencesModule': {'references': [{'pmid': '35618048', 'type': 'BACKGROUND', 'citation': 'Perezgrovas-Olaria R, Audisio K, Cancelli G, Rahouma M, Ibrahim M, Soletti GJ, Chadow D, Demetres M, Girardi LN, Gaudino M. Deep Sternal Wound Infection and Mortality in Cardiac Surgery: A Meta-analysis. Ann Thorac Surg. 2023 Jan;115(1):272-280. doi: 10.1016/j.athoracsur.2022.04.054. Epub 2022 May 23.'}, {'pmid': '19880326', 'type': 'BACKGROUND', 'citation': 'Baillot R, Cloutier D, Montalin L, Cote L, Lellouche F, Houde C, Gaudreau G, Voisine P. Impact of deep sternal wound infection management with vacuum-assisted closure therapy followed by sternal osteosynthesis: a 15-year review of 23,499 sternotomies. Eur J Cardiothorac Surg. 2010 Apr;37(4):880-7. doi: 10.1016/j.ejcts.2009.09.023. Epub 2009 Oct 31.'}, {'pmid': '30604928', 'type': 'BACKGROUND', 'citation': 'Polykandriotis E, Horch RE, Jost M, Arkudas A, Kees F, Schmitz M. Can systemically administered antibiotics be detected in wound tissues and surfaces under negative pressure wound therapy? Int Wound J. 2019 Apr;16(2):503-510. doi: 10.1111/iwj.13063. Epub 2019 Jan 3.'}, {'pmid': '24674131', 'type': 'BACKGROUND', 'citation': 'Ida Y, Matsumura H, Onishi M, Ono S, Imai R, Watanabe K. Measurement of vancomycin hydrochloride concentration in the exudate from wounds receiving negative pressure wound therapy: a pilot study. Int Wound J. 2016 Apr;13(2):204-8. doi: 10.1111/iwj.12260. Epub 2014 Mar 28.'}, {'pmid': '28224048', 'type': 'BACKGROUND', 'citation': 'Rowan MP, Niece KL, Rizzo JA, Akers KS. Wound Penetration of Cefazolin, Ciprofloxacin, Piperacillin, Tazobactam, and Vancomycin During Negative Pressure Wound Therapy. Adv Wound Care (New Rochelle). 2017 Feb 1;6(2):55-62. doi: 10.1089/wound.2016.0698.'}, {'pmid': '39711425', 'type': 'DERIVED', 'citation': 'Kolek M, Duricova J, Brozmanova H, Sistik P, Jurica J, Kankova K, Motyka O, Kacirova I. Vancomycin wound penetration in open-heart surgery patients receiving negative pressure wound therapy for deep sternal wound infection. Ann Med. 2025 Dec;57(1):2444544. doi: 10.1080/07853890.2024.2444544. Epub 2024 Dec 23.'}]}, 'descriptionModule': {'briefSummary': 'Only a limited number of studies have been published that monitored the penetration of antibiotics from blood into exudate in patients treated with negative pressure wound therapy (NPWT), and that evaluated the adequacy of current dosage regimens according to antibiotic tissue concentrations. A higher migration rate of several antibiotics (including vancomycin) to exudate has been reported in patients with skin ulcers, skin defects, burns, and traumatic wounds treated with NPWT compared to patients without NPWT.\n\nIn the present study, the investigators will evaluate the pharmacokinetic profile and wound penetration of vancomycin in open-heart surgery patients with post-sternotomy deep sternal wound infection receiving NPWT.', 'detailedDescription': 'For this prospective observational study, consecutive patients treated with NPWT for post-sternotomy deep sternal wound infection (DSWI) will be enrolled. On the first day of the study, serum and exudate samples will be synchronously collected at 0 (pre-dose), 0.5, 1, 2, 3, and 6 hours after vancomycin administration. On the following three consecutive days, additional samples will be collected, only before vancomycin administration.\n\nThe ratio of average vancomycin concentration in wound exudate to serum will be observed for free (unbound) and for total (bound + unbound) concentration. The percentage of free vancomycin in wound exudate and in serum will be observed. The level of vancomycin wound penetration will be observed for three days. The total hospital stay in patients with DSWI versus those without DSWI will be recorded, together with the in-hospital or 90-day mortality, together with late DSWI recurrence. All-cause mortality will be analyzed during a median follow-up of 2.5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with deep sternal wound infection after open-heart surgery', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 18 years\n* clinical and laboratory signs of significant infection\n* indication for NPWT with concomitant antibiotic therapy\n\nExclusion Criteria:\n\n\\- none'}, 'identificationModule': {'nctId': 'NCT06506032', 'briefTitle': 'Vancomycin and Negative Pressure Therapy for Post-sternotomy Deep Sternal Wound Infection', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Ostrava'}, 'officialTitle': 'Clinical Effect and Wound Penetration of Vancomycin in Open-heart Surgery Patients Receiving Negative Pressure Wound Therapy for Deep Sternal Wound Infection', 'orgStudyIdInfo': {'id': 'KCH-24-DSWI-vanko'}, 'secondaryIdInfos': [{'id': '06/RVO-FNOs/2021', 'type': 'OTHER_GRANT', 'domain': 'University Hospital Ostrava'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated with NPWT with DSWI', 'description': 'Patients with deep sternal wound infection were enrolled in this study group.', 'interventionNames': ['Drug: Intravenous Vancomycin administration']}, {'label': 'Patients without DSWI after cardiac surgery', 'description': 'Patients without deep sternal wound infection after cardiac surgery were enrolled in this study group.', 'interventionNames': ['Other: Standard postoperative therapy']}], 'interventions': [{'name': 'Intravenous Vancomycin administration', 'type': 'DRUG', 'description': 'Vancomycin was administered to the patients at the discretion of the physician', 'armGroupLabels': ['Patients treated with NPWT with DSWI']}, {'name': 'Standard postoperative therapy', 'type': 'OTHER', 'description': 'The patients received standard postoperative therapy', 'armGroupLabels': ['Patients without DSWI after cardiac surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '703 00', 'city': 'Ostrava', 'state': 'Moravian-Silesian Region', 'country': 'Czechia', 'facility': 'University of Ostrava', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '708 00', 'city': 'Ostrava', 'state': 'Moravian-Silesian Region', 'country': 'Czechia', 'facility': 'Technical University of Ostrava', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '708 52', 'city': 'Ostrava', 'state': 'Moravian-Silesian Region', 'country': 'Czechia', 'facility': 'University Hospital Ostrava', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '625 00', 'city': 'Brno', 'state': 'South Moravian', 'country': 'Czechia', 'facility': 'Masaryk University', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '656 63', 'city': 'Brno', 'state': 'South Moravian', 'country': 'Czechia', 'facility': 'Masaryk Memorial Cancer Institute', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}], 'overallOfficials': [{'name': 'Martin Kolek, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Ostrava'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make individual participant data available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Ostrava', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Ostrava', 'class': 'OTHER'}, {'name': 'Masaryk University', 'class': 'OTHER'}, {'name': 'Masaryk Memorial Cancer Institute', 'class': 'OTHER'}, {'name': 'Technical University of Ostrava', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}