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

• Sponsor: Columbia University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02767427
• Collaborator: Orthopaedic Scientific Research Foundation Inc (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 54.2
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infection; Spinal Injuries	Device: Chlorhexidine Wipes; Other: No intervention	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: The Value of Home Chlorhexidine Pre-Surgical Wash Before Spine Surgery
• Actual Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: May 31, 2018
• Anticipated Study Completion Date: Aug 7, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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 Names: 4% Chlorhexidine Wipes Chlorhexidine Gluconate Skin Prep Cloths Sage Skin Prep Cloths
Experimental: 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.	Other: No intervention; Chlorhexidine wipes will not be used though it is a commonly used pre-operative skin cleansing measure.

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Cutaneous Bacterial Load After Surgery [Pre-Surgery and Post Surgery, up to 4 hours]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Irving Medical Center	New York	New York	United States	10034

Sponsors and Collaborators

• Columbia University
• Orthopaedic Scientific Research Foundation Inc

Investigators

• Principal Investigator: Kiehyun D Riew, MD, Columbia University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 2, 2018

More Information

Publications

None provided.

• Responsible Party: Kiehyun Riew, Professor of Orthopedic Surgery at the Columbia University Medical Center, Columbia University
• ClinicalTrials.gov Identifier: NCT02767427
• Other Study ID Numbers: AAAP8304
• First Posted: May 10, 2016
• Last Update Posted: Feb 18, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Kiehyun Riew, Professor of Orthopedic Surgery at the Columbia University Medical Center, Columbia University: Infection Control; Preoperative Care; Chlorhexidine; Pre-Surgical Wash; Spine Surgery; Surgical site infections; Cutaneous bacterial load on skin
• Additional relevant MeSH terms: Infections; Spinal Injuries; Chlorhexidine; Chlorhexidine gluconate

Study Results

Participant Flow

Arm/Group Title	At-Home Chlorhexidine	No At-Home Chlorhexidine
Arm/Group Description	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. 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.	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. No intervention: Chlorhexidine wipes will not be used though it is a commonly used pre-operative skin cleansing measure.
Period Title: Overall Study
STARTED	21	19
COMPLETED	21	19
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	At-Home Chlorhexidine	No At-Home Chlorhexidine	Total
Arm/Group Description	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 (CHG) 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. 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.	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. No intervention: Chlorhexidine wipes will not be used though it is a commonly used pre-operative skin cleansing measure.	Total of all reporting groups
Overall Participants	21	19	40
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	18 85.7%	12 63.2%	30 75%
>=65 years	3 14.3%	7 36.8%	10 25%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.05 (9.12)	59.79 (13.10)	57.87 (11.39)
Sex: Female, Male (Count of Participants)
Female	7 33.3%	6 31.6%	13 32.5%
Male	14 66.7%	13 68.4%	27 67.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	2 10.5%	2 5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 4.8%	2 10.5%	3 7.5%
White	19 90.5%	14 73.7%	33 82.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 4.8%	1 5.3%	2 5%
Region of Enrollment (Count of Participants)
United States	21 100%	19 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Cutaneous Bacterial Load After Surgery
Description	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.
Time Frame	Pre-Surgery and Post Surgery, up to 4 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	At-Home Chlorhexidine	No At-Home Chlorhexidine
Arm/Group Description	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. 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.	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. No intervention: Chlorhexidine wipes will not be used though it is a commonly used pre-operative skin cleansing measure.
Measure Participants	21	19
Subjects with bacterial colonies	0 0%	18 94.7%
Subjects without bacterial colonies	21 100%	1 5.3%
Subjects with bacterial colonies	0 0%	0 0%
Subjects without bacterial colonies	21 100%	19 100%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	At-Home Chlorhexidine, No At-Home Chlorhexidine
	Comments
	Type of Statistical Test	Equivalence
	Comments	An equivalence test on data from a parallel-group design with sample sizes of 18 in the reference group and 18 in the treatment group achieves 80% power. The significance was set at 5%. The standard deviation was 1.00, and the equivalence limits were set at -1.00 and 1.00.
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 1 sided
	Comments	Two one-sided t-tests were conducted with 18 in each group.

Adverse Events

Time Frame	The forty enrolled patients were all consented and followed for data collection over the span of 15 months. Each patient was followed for up to 6 weeks after surgery to ensure that there were no postoperative infections.
Arm/Group Title	At-Home Chlorhexidine		No At-Home Chlorhexidine
Arm/Group Description	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. 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.		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. No intervention: Chlorhexidine wipes will not be used though it is a commonly used pre-operative skin cleansing measure.
All Cause Mortality
	At-Home Chlorhexidine		No At-Home Chlorhexidine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/19 (0%)
Serious Adverse Events
	At-Home Chlorhexidine		No At-Home Chlorhexidine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	At-Home Chlorhexidine		No At-Home Chlorhexidine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.