2% Chlorhexidine Gluconate Skin Cloths to Prevent SSI in Spine Surgery Patients
Completed · Phase 3
Conditions studied: Surgical Site Infections, Post Operative Complication
In brief
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).
Key facts
- Study ID
- NCT02490631
- Run by
- Vanderbilt University
- People needed
- 158
- Starts
- 2015-08-01
- Expected to finish
- 2018-12-31
- Last updated by the study team
- 2021-01-06
Who can join
Age: 19 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients scheduled for a neuro-spine procedure and have 2 of the following risk factors:
- Diabetic OR
- BMI>30 OR
- ASA>2 OR
- pre-operatively hospitalized OR
- >60 years old OR
- chronic steroids/immunosuppressive medications OR
- prior history of SSI
You may not qualify if…
- Unable to consent
- Non English speaking
- Known allergy to any of the ingredients contained in SAGE chlorhexidine gluconate cloths
- Current infection or history of spine infections
- Patients with tumors or intradural spinal pathology.
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.