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

July 22, 2021 updated by: Parth Bhavesh Gada, The Grant Medical College & Sir J.J. Group of Hospitals

A Randomized Controlled Study Assessing Prolonged Parenteral Antibiotics Versus Single-time Intra-operative Intra-dermal Antibiotic Administration in Elective Clean and Clean-contaminated Surgeries for Prevention of Surgical Site Infections

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients undergoing above 18 years of age, giving consent and undergoing open or laparoscopic elective, CDC class I & II surgeries will be recruited. Cases will be randomised into two cohorts viz: parenteral antibiotic (Group A) vs single-time intra-operative intra-dermal antibiotic administration group (Group B). In operation theatre, after induction of anaesthesia, Group A will receive parenteral ceftriaxone (15-20mg/kg) whereas Group B will receive single-time intra-operative intra-dermal ceftriaxone (15-20mg/kg diluted in 10 ml normal saline). Post-operatively, incision site will be covered with occlusive dressing. First check-dressing will be done after 48 hours as per the existing institutional practices. After that surgical site will be inspected daily for wound infection. Patients with healthy wound will be discharged at the discretion of the treating surgeon and will be asked to follow up in General Surgery OPD weekly for one month. Cases who developed an SSI will have samples collected from the afflicted area for bacterial culture and antibiotic susceptibility testing. On development of SSI, the treating clinical team will commence antibiotic therapy as per their protocols.

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400008
        • Recruiting
        • Grant Government Medical College and Sir JJ Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Rajeshwari Bhat
        • Sub-Investigator:
          • Nikhil Dhimole

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Local
Participants will receive single-time intra-operative intra-dermal ceftriaxone (15-20mg/kg diluted in 10 ml normal saline)
Drug: Ceftriaxone Sodium
Intravenous vs local action
ACTIVE_COMPARATOR: Parenteral
Participants will receive parenteral ceftriaxone (15-20mg/kg) for prolonged duration as per local protocol
Drug: Ceftriaxone Sodium
Intravenous vs local action

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Surgical site infection
Time Frame: 1 month

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
Time Frame: 1 month
Microorganism grown on wound swab - Nominal data
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total duration of hospital stay
Time Frame: 1 month
Number of days of stay in the hospital - Ratio data (Numerical)
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Grant Medical College & Sir J.J. Group of Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

January 1, 2022

Study Registration Dates

First Submitted

July 21, 2021

First Submitted That Met QC Criteria

July 22, 2021

First Posted (ACTUAL)

July 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 26, 2021

Last Update Submitted That Met QC Criteria

July 22, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • generalsurgery/2021/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD will be available after contacting the PI on parthg1895@gmail.com

IPD Sharing Time Frame

Will be available on completion of the study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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