The Value of Home Chlorhexidine Pre-Surgical Wash Before Spine Surgery
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Infectious Disease, Orthopedic |
| Therapuetic Areas: | Immunology / Infectious Diseases, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/31/2019 |
| Start Date: | February 2016 |
| End Date: | August 2019 |
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 home-application
group will be asked to shower the night before surgery, and to use a standardized
pre-packaged chlorhexidine gluconate 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.
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 home-application
group will be asked to shower the night before surgery, and to use a standardized
pre-packaged chlorhexidine gluconate 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.
To the investigator's knowledge no prior study has evaluated the effects of cleaning the skin
at home before surgery in patients undergoing spine surgery. This study will investigate
whether patients who use a chlorhexidine cleansing wipe have decreased amounts of bacteria on
their skin when they arrive for scheduled spine surgery. Spine surgeons strive to decrease
infections in their patients, so it is important to see if this intervention helps to do
this.
at home before surgery in patients undergoing spine surgery. This study will investigate
whether patients who use a chlorhexidine cleansing wipe have decreased amounts of bacteria on
their skin when they arrive for scheduled spine surgery. Spine surgeons strive to decrease
infections in their patients, so it is important to see if this intervention helps to do
this.
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
We found this trial at
1
site
630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Kiehyun D Riew, MD
Phone: 212-932-4410
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
Click here to add this to my saved trials
