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

NCT ID: NCT02767427

Last Updated: 2023-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-05-31

Brief 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.

Detailed 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.

Conditions

Infection; Spinal Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

At-Home Chlorhexidine

Those randomized into the chlorhexidine group will be asked to shower the night before surgery, and to use a standardized pre-packaged Chlorhexidine Wipes (chlorhexidine gluconate wipes) on their surgical site after thoroughly drying those areas. They will be asked to use a second wipe in each area the morning of surgery. Those who forget to use the wipe in the morning were allowed to use the wipe in the pre-operative area and included if this occurs more than one hour before skin prep.

Group Type: ACTIVE_COMPARATOR

Chlorhexidine Wipes

Intervention Type: DEVICE

(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.

No At-Home Chlorhexidine

Participants in this group will not use chlorhexidine wipes (no intervention), as is standard of care, prior to their surgical site being cleansed by the surgical team pre-operatively.

Group Type: EXPERIMENTAL

No intervention

Intervention Type: OTHER

Chlorhexidine wipes will not be used though it is a commonly used pre-operative skin cleansing measure.

Interventions

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.

Intervention Type: DEVICE

No intervention

Chlorhexidine wipes will not be used though it is a commonly used pre-operative skin cleansing measure.

Intervention Type: OTHER

Other Intervention Names

4% Chlorhexidine Wipes; Chlorhexidine Gluconate; Skin Prep Cloths; Sage Skin Prep Cloths

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orthopaedic Scientific Research Foundation Inc

UNKNOWN

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Kiehyun Riew

Professor of Orthopedic Surgery at the Columbia University Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kiehyun D Riew, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AAAP8304

Identifier Type: -

Identifier Source: org_study_id