2% Chlorhexidine Gluconate Skin Cloths to Prevent SSI in Spine Surgery Patients
Condition: Surgical Site Infections; Post Operative Complication
MeSH terms: Infections; Surgical Wound Infection; Postoperative Complications
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): 2% chlorhexidine gluconate cloths
Intervention type(s): Drug
Intervention description(s): Cleansing twice pre-operatively jawline to toes with 2% chlorhexidine gluconate cloths
Other intervention name(s): SAGE patient preoperative skin preparation cloths
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: skin flora