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

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

Status and phase: Withdrawn; Phase 4

Conditions: Surgical Site Infection; Surgical Wound Infection

Treatments: Drug: Ceftriaxone Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT04975945

generalsurgery/2021/01

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Local

Experimental group

Description:

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

Treatment:

Drug: Ceftriaxone Sodium

Parenteral

Active Comparator group

Description:

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

Treatment:

Drug: Ceftriaxone Sodium