The Value of Home Chlorhexidine Pre-Surgical Wash Before Spine Surgery

Infection Clinical Trial

Official title:

The Value of Home Chlorhexidine Pre-Surgical Wash Before Spine Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02767427
• Other study ID #: AAAP8304
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: May 31, 2018

Study information

• Verified date: February 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Infections
• Spinal Injuries

Intervention

Device:
• Chlorhexidine Wipes
(Standard of Care) Chlorhexidine wipes are a commonly used pre-operative skin cleansing measure, designed to reduce bacterial load on the skin of the surgical site.

Other:
• No intervention
Chlorhexidine wipes will not be used though it is a commonly used pre-operative skin cleansing measure.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Orthopaedic Scientific Research Foundation Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Cutaneous Bacterial Load After Surgery	All specimens were taken by a sterile BD E-Swab. All samples will be sent immediately after acquisition to the microbiology lab for analysis within four hours.	Pre-Surgery and Post Surgery, up to 4 hours