drugset / Trial / NCT02490631

2% Chlorhexidine Gluconate Skin Cloths to Prevent SSI in Spine Surgery Patients

NCT02490631

Phase 3 Completed 158 enrolled Vanderbilt University Sage Products, Inc. · collab
RandomizedParallel-groupSingle-blindPrevention

Summary

Surgical site infection (SSI) following spinal surgery is a frequent complication and results in higher morbidity, mortality and healthcare costs. SSI following adult spinal surgery is a frequent complication that has been reported to occur in 0.7-12.0% of patients and result in higher postoperative morbidity, mortality and health care costs. Vanderbilt University Medical Center SSI rate is 7%. Treatment for SSI can be challenging often requiring revision surgery, long-term antibiotics, and prolonged hospitalization. The accurate identification of risk factors is thus important in the development of strategies to prevent these potentially devastating infections. This study proposes a randomized, controlled trial of neuro-spine patients of 2% chlorhexidine gluconate skin preparation cloths for the prevention of post op surgical site infections in spine patients. Use of CHG cloths the night before and morning of surgery (neckline to toes) will affect (decrease rates) of SSI compared to patients who receive routine standard of care (soap and water pre-op, day of surgery and daily post-operative).

Timeline

Start
2015-08
Primary completion
2018-12-30
Completion
2018-12-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Chlorhexidine gluconate Other / unclassified 2 % Topical

Indications

No indication recorded.