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

Sponsor

The Grant Medical College & Sir J.J. Group of Hospitals (Other)

Overall Status

Recruiting

CT.gov ID

NCT04975945

Collaborator

(none)

250

Enrollment

Location

Arms

Anticipated Duration (Months)

49.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Surgical Wound Infection Surgical Site Infection	Drug: Ceftriaxone Sodium	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence of Surgical site infection [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: Purulent drainage, with or without laboratory confirmation, from the superficial incision. Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision. 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. Diagnosis of superficial incisional SSI by the surgeon or attending physician
Organism isolated from wound [1 month]
Microorganism grown on wound swab - Nominal data

Secondary Outcome Measures

Total duration of hospital stay [1 month]
Number of days of stay in the hospital - Ratio data (Numerical)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.