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

NCT02767427 | Completed Results FDA Device

• 1 other identifier: AAAP8304
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection; Spinal Injuries

Keywords

Infection Control; Preoperative Care; Chlorhexidine; Pre-Surgical Wash; Spine Surgery; Surgical site infections; Cutaneous bacterial load on skin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

At-Home Chlorhexidine

ACTIVE COMPARATOR

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.

Device: Chlorhexidine Wipes

No At-Home Chlorhexidine

EXPERIMENTAL

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.

Other: No intervention

Interventions

Chlorhexidine Wipes 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.

Also known as: 4% Chlorhexidine Wipes, Chlorhexidine Gluconate, Skin Prep Cloths, Sage Skin Prep Cloths

At-Home Chlorhexidine

No intervention OTHER

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

No At-Home Chlorhexidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• Scheduled for elective spine surgery at Columbia University Medical Center

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Orthopaedic Scientific Research Foundation Inc: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10034, United States

Location

MeSH Terms

Conditions

Infections; Spinal Injuries; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Back Injuries; Wounds and Injuries; Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Kiehyun Daniel Riew, Professor of Orthopedic Surgery
• Organization: Columbia University

kr2637@cumc.columbia.edu

212-932-4410

Study Officials

• Kiehyun D Riew, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopedic Surgery at the Columbia University Medical Center

Study Record Dates

• First Submitted: April 23, 2016
• First Posted: May 10, 2016
• Study Start: February 1, 2016
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: February 6, 2023
• Results First Posted: July 16, 2019

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)