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| Name | Class |
|---|---|
| Orthopaedic Scientific Research Foundation Inc | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kiehyun D Riew, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10034 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Pre-Surgery and Post Surgery, up to 4 hours |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kiehyun Daniel Riew, Professor of Orthopedic Surgery | Columbia University | 212-932-4410 | kr2637@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 2, 2018 | May 17, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D013124 | Spinal Injuries |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D014946 | Wound Infection |
| D011183 | Postoperative Complications |
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| No intervention | Other | Chlorhexidine wipes will not be used though it is a commonly used pre-operative skin cleansing measure. |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | 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. | 0 | 19 | 0 | 19 | 0 | 19 |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |