Assessing Parenteral Antibiotics Versus Single-time Intra-operative Intra-dermal Antibiotic Administration for Prevention of SSI

NCT04975945 | Withdrawn Phase 4

• 1 other identifier: generalsurgery/2021/01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to study the incidence of surgical site infection when patients are given local versus parenteral antibiotics

Conditions

Surgical Wound Infection; Surgical Site Infection

Keywords

Ceftriaxone; Surgical wound infection

Outcome Measures

Primary Outcomes (2)

• Incidence of Surgical site infection

  Infection occurs within 30 days after the operation and infection involves only skin or subcutaneous tissue of the incision and at least one of the following: 1. Purulent drainage, with or without laboratory confirmation, from the superficial incision. 2. Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision. 3. At least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat and superficial incision is deliberately opened by surgeon, unless the incision is culture-negative. 4. Diagnosis of superficial incisional SSI by the surgeon or attending physician

  1 month

• Organism isolated from wound

  Microorganism grown on wound swab - Nominal data

  1 month

Secondary Outcomes (1)

• Total duration of hospital stay

  1 month

Study Arms (2)

Local

EXPERIMENTAL

Participants will receive single-time intra-operative intra-dermal ceftriaxone (15-20mg/kg diluted in 10 ml normal saline)

Drug: Ceftriaxone Sodium

Parenteral

ACTIVE COMPARATOR

Participants will receive parenteral ceftriaxone (15-20mg/kg) for prolonged duration as per local protocol

Drug: Ceftriaxone Sodium

Interventions

Ceftriaxone Sodium DRUG

Intravenous vs local action

Local; Parenteral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients above the age of 18 years
• Patients undergoing open and laparoscopic elective, CDC class I \& II surgeries

You may not qualify if:

• Patients exhibiting hypersensitivity reaction to ceftriaxone
• 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.

Sponsors & Collaborators

• The Grant Medical College & Sir J.J. Group of Hospitals: lead

Study Sites (1)

Grant Government Medical College and Sir JJ Hospital

Mumbai, Maharashtra, 400008, India

Location

Related Publications (6)

• 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.

  PMID: 10196487 BACKGROUND

• 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.

  PMID: 27064370 BACKGROUND

• Kotisso B, Aseffa A. Surgical wound infection in a teaching hospital in Ethiopia. East Afr Med J. 1998 Jul;75(7):402-5.

  PMID: 9803631 BACKGROUND

• 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.

  PMID: 25440122 BACKGROUND

• 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.

  PMID: 1524269 BACKGROUND

• Patel IH, Kaplan SA. Pharmacokinetic profile of ceftriaxone in man. Am J Med. 1984 Oct 19;77(4C):17-25.

  PMID: 6093513 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Ceftriaxone

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Resident

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: July 26, 2021
• Study Start: August 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2022
• Last Updated: March 25, 2025

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Will be available on completion of the study

Locations

IN (1)