Infection, Spinal Injuries
Conditions
Keywords
Infection Control, Preoperative Care, Chlorhexidine, Pre-Surgical Wash, Spine Surgery, Surgical site infections, Cutaneous bacterial load on skin
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.
Interventions
DEVICEChlorhexidine 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.
OTHERNo intervention
Chlorhexidine wipes will not be used though it is a commonly used pre-operative skin cleansing measure.
Sponsors
Orthopaedic Scientific Research Foundation Inc
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 (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. | 21 |
| 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.
No intervention: Chlorhexidine wipes will not be used though it is a commonly used pre-operative skin cleansing measure. | 19 |
| Total | 40 |
Baseline characteristics
| Characteristic | No At-Home Chlorhexidine | Total | At-Home Chlorhexidine |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 10 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 30 Participants | 18 Participants |
| Age, Continuous | 59.79 years STANDARD_DEVIATION 13.1 | 57.87 years STANDARD_DEVIATION 11.39 | 56.05 years STANDARD_DEVIATION 9.12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 14 Participants | 33 Participants | 19 Participants |
| Region of Enrollment United States | 19 Participants | 40 Participants | 21 Participants |
| Sex: Female, Male Female | 6 Participants | 13 Participants | 7 Participants |
| Sex: Female, Male Male | 13 Participants | 27 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 19 |
| other Total, other adverse events | 0 / 21 | 0 / 19 |
| serious Total, serious adverse events | 0 / 21 | 0 / 19 |
Outcome results
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.
Time frame: Pre-Surgery and Post Surgery, up to 4 hours
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| At-Home Chlorhexidine | Number of Patients With Cutaneous Bacterial Load After Surgery | Presurgery Bacterial Colony Count | Subjects with bacterial colonies | 0 Participants |
| At-Home Chlorhexidine | Number of Patients With Cutaneous Bacterial Load After Surgery | Presurgery Bacterial Colony Count | Subjects without bacterial colonies | 21 Participants |
| At-Home Chlorhexidine | Number of Patients With Cutaneous Bacterial Load After Surgery | Postsurgical Bacterial Colony Count | Subjects with bacterial colonies | 0 Participants |
| At-Home Chlorhexidine | Number of Patients With Cutaneous Bacterial Load After Surgery | Postsurgical Bacterial Colony Count | Subjects without bacterial colonies | 21 Participants |
| No At-Home Chlorhexidine | Number of Patients With Cutaneous Bacterial Load After Surgery | Postsurgical Bacterial Colony Count | Subjects without bacterial colonies | 19 Participants |
| No At-Home Chlorhexidine | Number of Patients With Cutaneous Bacterial Load After Surgery | Presurgery Bacterial Colony Count | Subjects with bacterial colonies | 18 Participants |
| No At-Home Chlorhexidine | Number of Patients With Cutaneous Bacterial Load After Surgery | Postsurgical Bacterial Colony Count | Subjects with bacterial colonies | 0 Participants |
| No At-Home Chlorhexidine | Number of Patients With Cutaneous Bacterial Load After Surgery | Presurgery Bacterial Colony Count | Subjects without bacterial colonies | 1 Participants |
p-value: <0.05t-test, 1 sided