Overview

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

Status:
Completed

Trial end date:
2018-12-31

Target enrollment:
0

Participant gender:
All

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).

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Vanderbilt University

Collaborator:

Sage Products, Inc.

Treatments:

Chlorhexidine
Chlorhexidine gluconate

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- 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.