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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Surgical Wound Infection, Surgical Site Infection

Intervention / Treatment
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* Drug: Ceftriaxone Sodium


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: 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 | 1 month | 
| Organism isolated from wound | Microorganism grown on wound swab - Nominal data | 1 month | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ceftriaxone, Surgical wound infection