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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial of 2% Chlorhexidine Gluconate Skin Preparation Cloths for the Prevention of Post op Surgical Site Infections in Spine Patients (Decrease SSI or DeSSI)

Conditions
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Surgical Site Infections, Post Operative Complication

Intervention / Treatment
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* Drug: 2% chlorhexidine gluconate cloths


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm<br>Standard of care pre-operative cleansing with soap and water the night before and morning of surgery | |
| Experimental: Intervention Arm<br>2% chlorhexidine gluconate cloths the night before and morning of surgery | Drug: 2% chlorhexidine gluconate cloths<br>* Cleansing twice pre-operatively jawline to toes with 2% chlorhexidine gluconate cloths<br>* Other names: SAGE patient preoperative skin preparation cloths;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With Surgical Site Infection Development at 30 Days Post-operative | Evaluation daily using the CDC guidelines, daily measurements and deidentified photos | post op day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Positive or Abnormal Skin Cultures on Day of Surgery, Day of Discharge, 30 Days Post-op | Skin swabs collected on Day of Surgery, Day of Discharge, 30 days post-op | Day of Surgery, Day of Discharge, 30 days post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin flora