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Clinical Trials/CTRI/2024/04/066362
CTRI/2024/04/066362Not yet recruitingPhase 4

Impact of multipronged interventions targeting healthcare professionals in reducing surgical site infections and identifying the challenges in adoption of these interventions- an implementation research

Indian Council of Medical Research7 sites in 1 country6,860 target enrollmentStarted: June 1, 2024Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Enrollment
6,860
Locations
7
Primary Endpoint
The rate of surgical site infection till 30 days after surgery (90 days if implant) using CDC definition of SSI in pre-intervention versus post-intervention phase for clean, clean-contaminated and contaminated surgeries

Study Overview

Brief Summary

The study is "Impact of multipronged interventions targeting healthcare professionals in reducing surgical site infections and identifying the challenges in adoption of these interventions."

Multicentric study (7 sites in India) with mixed method design. 

Phase-I will involve formative research and practice analysis. Phase-II will involve co-development of the multipronged interventions. Phase-III will involve deployment of the multipronged interventions and process evaluation. Phase-IV will involve impact assessment and dissemination of results.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
1.00 Year(s) to 85.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Surgical patients undergoing elective or emergency procedure (open or laparoscopic) under general surgery, neurosurgery, orthopedics, pediatric surgery, plastic surgery, urology.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

The rate of surgical site infection till 30 days after surgery (90 days if implant) using CDC definition of SSI in pre-intervention versus post-intervention phase for clean, clean-contaminated and contaminated surgeries

Time Frame: The rate of surgical site infection till 30 days after surgery (90 days if implant) using CDC definition of SSI in pre-intervention versus post-intervention phase for clean, clean-contaminated and contaminated surgeries

Secondary Outcomes

  • The number of ICU admissions averted and number of readmissions averted in clean, clean-contaminated and contaminated surgeries by adoption of multipronged interventions(30 days after surgery)
  • The length of index hospital admission in pre-intervention and intervention phase for clean, clean-contaminated and contaminated surgeries.(post-operatively)
  • The antimicrobial consumption indicators (Days of therapy) in the pre-intervention and intervention phase for clean, clean-contaminated and contaminated surgeries(peri-operative period)
  • The percentage of patients receiving single dose of antimicrobial prophylaxis in the pre-intervention and intervention phase for clean, clean-contaminated and contaminated surgeries(Peri-operative period)
  • The percentage of patients receiving prolonged antimicrobial prophylaxis in the pre-intervention and intervention phase for clean, clean-contaminated and contaminated surgeries(Peri-operative period)
  • The percentage of irrational combinations of drugs (double gram positive, double gram negative or double anaerobic coverage) for surgical antimicrobial prophylaxis in the pre-intervention and intervention phase for clean, clean-contaminated and contaminated surgeries(Peri-operative period)
  • The number of deaths prevented in clean, clean-contaminated and contaminated surgeries by adoption of multipronged interventions(30 days after surgery)
  • Acceptance of these multipronged interventions and challenges in their implementation by healthcare professionals(Peri-operative)

Investigators

Sponsor Class
Government funding agency
Responsible Party
Principal Investigator
Principal Investigator

Dr Rachna Rohilla

All India Institute of Medical Sciences, Bathinda

Study Sites (7)

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