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Phase 3 N=157 Randomized Single-blind Prevention

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

Surgical Site Infections · Post Operative Complication

Enrolled (actual)
157
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Participants With Surgical Site Infection Development at 30 Days Post-operative — 5; 5 Participants — p=0.456

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
2% chlorhexidine gluconate cloths (Drug)
Age
Adult, Older Adult · 19+ yrs
Sex
All
Sponsor
Vanderbilt University
Primary completion
Dec 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Participants With Surgical Site Infection Development at 30 Days Post-operative
5; 5 0.456
SECONDARY
Number of Participants With Positive or Abnormal Skin Cultures on Day of Surgery, Day of Discharge, 30 Days Post-op
41; 7; 21; 9; 32; 25 .019 sig

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).

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02490631). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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