Effect of skin preparation with chlorhexidine-alcohol versus chlorhexidine-cetrimide followed by povidone iodine before surgery on the surgical wound infection rates: a randomized controlled trial.
Phase 4
- Conditions
- Health Condition 1: null- Patients with gastrointestinal disorder
- Registration Number
- CTRI/2013/09/003982
- Lead Sponsor
- AIIMS NEW DELHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 1340
Inclusion Criteria
All patients between 18 to 70 years of age
ASA class 1 or 2
Elective gastrointestinal surgical procedures
Only patients off antibiotics for at least 5 days will be considered for inclusion in the study.
Exclusion Criteria
Patients who do not consent.
known allergy to study agents (chlorhexidineâ??cetrimide or povidoneâ??iodine)
uncontrolled diabetes (blood glucose levels >200 mg/dl despite medical treatment)
immunosuppressive medications
those undergoing emergency, laparoscopic or re-operative procedures
those with clean wounds / contaminated wound/dirty wounds
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the frequency of surgical site infection within 30 days of surgery in patients undergoing preoperative skin preparation either with three applications of chlorhexidine-alcoholversus chlorhexidine-cetrimide followed by povidone iodine on the postoperative surgical wound infection rates <br/ ><br>Timepoint: From Post operative day 1 to post op day 30
- Secondary Outcome Measures
Name Time Method To assess the types of surgical site infection in the two groups. <br/ ><br>To compare adverse events associated with the two skin preparation protocols. <br/ ><br>Timepoint: with in 30 days of surgery