Assessing Parenteral Antibiotics Versus Single-time Intra-operative Intra-dermal Antibiotic Administration for Prevention of SSI
NCT ID: NCT04975945
Last Updated: 2025-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2021-08-31
2022-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Local
Participants will receive single-time intra-operative intra-dermal ceftriaxone (15-20mg/kg diluted in 10 ml normal saline)
Ceftriaxone Sodium
Intravenous vs local action
Parenteral
Participants will receive parenteral ceftriaxone (15-20mg/kg) for prolonged duration as per local protocol
Ceftriaxone Sodium
Intravenous vs local action
Interventions
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Ceftriaxone Sodium
Intravenous vs local action
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing open and laparoscopic elective, CDC class I \& II surgeries
Exclusion Criteria
* Patients who are immunocompromised (retroviral disease and corticosteroid use)
* Patients not consenting to be a part of this study
* Pregnancy
* Febrile illness or leucocytosis at the time of surgery
* Planned for staged/multiple interventions during the hospital stay (endoscopies, image-guided biopsies etc)
* Patients with a possible septic focus distant from the surgical site such as diabetic foot ulcers.
18 Years
ALL
No
Sponsors
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The Grant Medical College & Sir J.J. Group of Hospitals
OTHER_GOV
Responsible Party
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Parth Bhavesh Gada
Junior Resident
Locations
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Grant Government Medical College and Sir JJ Hospital
Mumbai, Maharashtra, India
Countries
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References
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Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1999 Apr;27(2):97-132; quiz 133-4; discussion 96.
Akhter MS, Verma R, Madhukar KP, Vaishampayan AR, Unadkat PC. Incidence of surgical site infection in postoperative patients at a tertiary care centre in India. J Wound Care. 2016 Apr;25(4):210-2, 214-7. doi: 10.12968/jowc.2016.25.4.210.
Kotisso B, Aseffa A. Surgical wound infection in a teaching hospital in Ethiopia. East Afr Med J. 1998 Jul;75(7):402-5.
Young PY, Khadaroo RG. Surgical site infections. Surg Clin North Am. 2014 Dec;94(6):1245-64. doi: 10.1016/j.suc.2014.08.008. Epub 2014 Oct 3.
Holtz TH, Wenzel RP. Postdischarge surveillance for nosocomial wound infection: a brief review and commentary. Am J Infect Control. 1992 Aug;20(4):206-13. doi: 10.1016/s0196-6553(05)80148-8.
Patel IH, Kaplan SA. Pharmacokinetic profile of ceftriaxone in man. Am J Med. 1984 Oct 19;77(4C):17-25.
Other Identifiers
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generalsurgery/2021/01
Identifier Type: -
Identifier Source: org_study_id
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