An interventional study of Chlorhexidine Wipes and No intervention in Infection and Spinal Injuries, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-06.
Sponsored by Columbia University · Not applicable, Interventional, and Prevention
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.
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.
2,093 studies on the registry are indexed under Infections; 364 are open to participants now.
This study's enrollment of 40 is below the median of 113 across 1,304 interventional studies indexed under Infections.
Browse Infections studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
(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
Chlorhexidine wipes will not be used though it is a commonly used pre-operative skin cleansing measure.
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
| Milestone | At-Home Chlorhexidine | No At-Home Chlorhexidine |
|---|---|---|
| Started | 21 | 19 |
| Completed | 21 | 19 |
| Not completed | 0 | 0 |
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.
| Participants | At-Home Chlorhexidine | No At-Home Chlorhexidine |
|---|---|---|
| Presurgery Bacterial Colony Count — Subjects with bacterial colonies | 0 | 18 |
| Presurgery Bacterial Colony Count — Subjects without bacterial colonies | 21 | 1 |
| Postsurgical Bacterial Colony Count — Subjects with bacterial colonies | 0 | 0 |
| Postsurgical Bacterial Colony Count — Subjects without bacterial colonies | 21 | 19 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| At-Home Chlorhexidine | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| No At-Home Chlorhexidine | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Age, Categorical(Participants) | At-Home Chlorhexidine | No At-Home Chlorhexidine | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 18 | 12 | 30 |
| >=65 years | 3 | 7 | 10 |
| Age, Continuous(years) | At-Home Chlorhexidine | No At-Home Chlorhexidine | Total |
|---|---|---|---|
| Mean | 56.05 ± 9.12 | 59.79 ± 13.10 | 57.87 ± 11.39 |
| Sex: Female, Male(Participants) | At-Home Chlorhexidine | No At-Home Chlorhexidine | Total |
|---|---|---|---|
| Female | 7 | 6 | 13 |
| Male | 14 | 13 | 27 |
| Race (NIH/OMB)(Participants) | At-Home Chlorhexidine | No At-Home Chlorhexidine | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 19 | 14 | 33 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(Participants) | At-Home Chlorhexidine | No At-Home Chlorhexidine | Total |
|---|---|---|---|
| United States | 21 | 19 | 40 |
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