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

Phase 3

Completed

Conditions: Surgical Site Infections
Post Operative Complication

Interventions: Drug: 2% chlorhexidine gluconate cloths

Registration Number: NCT02490631

Lead Sponsor: Vanderbilt University

Brief 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).

Detailed Description: Pre-operatively patients scheduled for neurosurgical spine cases will be evaluated and approached for interest, if consenting process completed, patients will be randomized to one of 2 arms in 1:1 through a block randomization table.

Those enrolled into the study arm will receive the CHG cloths and instructions for use from research personal. Those randomized to the control arm will receive standard of care skin cleansing by nursing staff.

All subjects who have signed consent will have a skin swab culture taken the day of screening and prior to cleansing with Chlorhexidine gluconate wipes close to the intended incision line. The investigators will also obtain skin swab cultures at site of incision preoperatively on the day of surgery, post-op day 4 or time of discharge and at the 30 day follow up.

Both groups will be evaluated daily by study personnel for the development of SSI until post-op day 4 or hospital discharge whichever one comes first. After dressing removal, a daily high definition picture will be taken of the incision line to further document signs of SSI development (pictures will not have any patient identifiable information). Additional evaluations will take place at the 30 day (+/- 7 days) post-op visit. Blinded evaluators utilizing the CDC guideline will grade the incision line for presence of SSI. Measured change in skin flora will be performed by comparing skin swab cultures of intervention group versus standard of care group and individual changes pre and post operatively.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 158

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	2% chlorhexidine gluconate cloths	2% chlorhexidine gluconate cloths the night before and morning of surgery

Primary Outcome Measures

Name	Time	Method
Participants With Surgical Site Infection Development at 30 Days Post-operative	post op day 30	Evaluation daily using the CDC guidelines, daily measurements and deidentified photos

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Positive or Abnormal Skin Cultures on Day of Surgery, Day of Discharge, 30 Days Post-op	Day of Surgery, Day of Discharge, 30 days post-op	Skin swabs collected on Day of Surgery, Day of Discharge, 30 days post-op