Clinical trial NCT04975945: Assessing Parenteral Antibiotics Versus Single-time Intra-operative Intra-dermal Antibiotic Administration for Prevention of SSI
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Surgical Wound Infection
Surgical Site Infection
Keywords: Ceftriaxone
Surgical wound infection
Lead sponsor: The Grant Medical College & Sir J.J. Group of Hospitals
Sponsor class: OTHER_GOV
First posted: 2021-07-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Surgical site infection
timeFrame: 1 month
measure: Organism isolated from wound
timeFrame: 1 month
Secondary outcomes:
measure: Total duration of hospital stay
timeFrame: 1 month
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Grant Government Medical College and Sir JJ Hospital
state: Maharashtra
Study officials:
References:
citation: 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.
citation: 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.
citation: Kotisso B, Aseffa A. Surgical wound infection in a teaching hospital in Ethiopia. East Afr Med J. 1998 Jul;75(7):402-5.
citation: 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.
citation: 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.
citation: Patel IH, Kaplan SA. Pharmacokinetic profile of ceftriaxone in man. Am J Med. 1984 Oct 19;77(4C):17-25.