N/A
N=40
The Value of Home Chlorhexidine Pre-Surgical Wash Before Spine Surgery
Infection · Spinal Injuries
Bottom Line
View on ClinicalTrials.gov: NCT02767427 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Number of Patients With Cutaneous Bacterial Load After Surgery — 0; 18; 21; 1 Participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Chlorhexidine Wipes (Device); No intervention (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Cutaneous Bacterial Load After Surgery |
0; 18; 21; 1; 0; 0 | <0.05 sig |
Summary
The study team hypothesizes that at-home cleansing of the surgical site with chlorhexidine wipes provide no added benefit to decreasing microbial activity or preventing surgical site infections.
Patients will be randomized to the chlorhexidine or no additional intervention groups. Patients will be randomized to use 4% chlorhexidine cloths, while the other half receive no additional intervention. Those randomized into the chlorhexidine gluconate (CHG) home-application group will be asked to shower the night before surgery, and to use a standardized pre-packaged CHG wipe (that the patients would receive at their pre-surgical consultation) on their surgical site after thoroughly drying those areas. The patients will be asked to use a second wipe in each area the morning of surgery. The surgical sites will be analyzed in two groups: anterior cervical and posterior spine. Each of these two groups will be randomized separately. All patients will undergo a standardized preoperative cleansing regimen. Once positioned, they will be cleansed with an alcohol solution. Then, the surgical site (either the anterior portion of the neck or the posterior area of the spine) will be scrubbed with chlorhexidine soaked brushes and then painted with chlorhexidine solution. Perioperative antibiotics will be given per attending surgeon preference. Cutaneous samples will be taken from the surgical site of each patient at each time point.
Eligibility Criteria
Inclusion Criteria
- 18 years old or older
- Scheduled for elective spine surgery at Columbia University Medical Center
Exclusion Criteria
- Unable to apply at-home chlorhexidine wipe by themselves
- Deemed "high risk" preoperatively by the treating surgeon
- Diagnosed with spine trauma
- Undergoing deformity correction surgery
- Unable to consent to the terms of the surgery
- Known infection at time of the index procedure
- Hospitalized within 1 week pre-operatively
- Allergic to chlorhexidine
- Immunocompromised
- End stage renal disease on dialysis
- Local or systemic skin disease (such as psoriasis, eczema, etc.)
- Open skin wounds
Data sourced from ClinicalTrials.gov (NCT02767427). 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.