Post Operative Complication, Surgical Site Infections
Conditions
Keywords
skin flora
Brief summary
Surgical site infection (SSI) following spinal surgery is a frequent complication and results in higher morbidity, mortality and healthcare costs. SSI following adult spinal surgery is a frequent complication that has been reported to occur in 0.7-12.0% of patients and result in higher postoperative morbidity, mortality and health care costs. Vanderbilt University Medical Center SSI rate is 7%. Treatment for SSI can be challenging often requiring revision surgery, long-term antibiotics, and prolonged hospitalization. The accurate identification of risk factors is thus important in the development of strategies to prevent these potentially devastating infections. This study proposes a randomized, controlled trial of neuro-spine patients of 2% chlorhexidine gluconate skin preparation cloths for the prevention of post op surgical site infections in spine patients. Use of CHG cloths the night before and morning of surgery (neckline to toes) will affect (decrease rates) of SSI compared to patients who receive routine standard of care (soap and water pre-op, day of surgery and daily post-operative).
Detailed description
Pre-operatively patients scheduled for neurosurgical spine cases will be evaluated and approached for interest, if consenting process completed, patients will be randomized to one of 2 arms in 1:1 through a block randomization table. Those enrolled into the study arm will receive the CHG cloths and instructions for use from research personal. Those randomized to the control arm will receive standard of care skin cleansing by nursing staff. All subjects who have signed consent will have a skin swab culture taken the day of screening and prior to cleansing with Chlorhexidine gluconate wipes close to the intended incision line. The investigators will also obtain skin swab cultures at site of incision preoperatively on the day of surgery, post-op day 4 or time of discharge and at the 30 day follow up. Both groups will be evaluated daily by study personnel for the development of SSI until post-op day 4 or hospital discharge whichever one comes first. After dressing removal, a daily high definition picture will be taken of the incision line to further document signs of SSI development (pictures will not have any patient identifiable information). Additional evaluations will take place at the 30 day (+/- 7 days) post-op visit. Blinded evaluators utilizing the CDC guideline will grade the incision line for presence of SSI. Measured change in skin flora will be performed by comparing skin swab cultures of intervention group versus standard of care group and individual changes pre and post operatively.
Interventions
Cleansing twice pre-operatively jawline to toes with 2% chlorhexidine gluconate cloths
Sponsors
Sage Products, Inc.
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Patients scheduled for a neuro-spine procedure and have 2 of the following risk factors: * Diabetic OR * BMI\>30 OR * ASA\>2 OR * pre-operatively hospitalized OR * \>60 years old OR * chronic steroids/immunosuppressive medications OR * prior history of SSI
Exclusion criteria
* Unable to consent * Non English speaking * Known allergy to any of the ingredients contained in SAGE chlorhexidine gluconate cloths * Current infection or history of spine infections * Patients with tumors or intradural spinal pathology.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Surgical Site Infection Development at 30 Days Post-operative | post op day 30 | Evaluation daily using the CDC guidelines, daily measurements and deidentified photos |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Positive or Abnormal Skin Cultures on Day of Surgery, Day of Discharge, 30 Days Post-op | Day of Surgery, Day of Discharge, 30 days post-op | Skin swabs collected on Day of Surgery, Day of Discharge, 30 days post-op |
Countries
United States
Participant flow
Pre-assignment details
One participant signed consent, was randomized to the chlorhexidine arm, but their surgery was cancelled, so they did not start the study. There is no data for this subject.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Pre-operative Cleansing Standard of care pre-operative cleansing with soap and water the night before and morning of surgery | 76 |
| 2% Chlorhexidine Gluconate 2% chlorhexidine gluconate cloths the night before and morning of surgery
2% chlorhexidine gluconate cloths: Cleansing twice pre-operatively jawline to toes with 2% chlorhexidine gluconate cloths | 75 |
| Total | 151 |
Baseline characteristics
| Characteristic | 2% Chlorhexidine Gluconate | Total | Standard of Care Pre-operative Cleansing |
|---|---|---|---|
| Age, Continuous | 66 years | 64 years | 63 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 75 participants | 151 participants | 76 participants |
| Sex: Female, Male Female | 34 Participants | 74 Participants | 40 Participants |
| Sex: Female, Male Male | 41 Participants | 77 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 76 | 0 / 75 |
| other Total, other adverse events | 0 / 76 | 0 / 75 |
| serious Total, serious adverse events | 0 / 76 | 0 / 75 |
Outcome results
Primary
Participants With Surgical Site Infection Development at 30 Days Post-operative
Evaluation daily using the CDC guidelines, daily measurements and deidentified photos
Time frame: post op day 30
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Pre-operative Cleansing | Participants With Surgical Site Infection Development at 30 Days Post-operative | 5 Participants |
| 2% Chlorhexidine Gluconate | Participants With Surgical Site Infection Development at 30 Days Post-operative | 5 Participants |
p-value: 0.456Chi-squared
Secondary
Number of Participants With Positive or Abnormal Skin Cultures on Day of Surgery, Day of Discharge, 30 Days Post-op
Skin swabs collected on Day of Surgery, Day of Discharge, 30 days post-op
Time frame: Day of Surgery, Day of Discharge, 30 days post-op
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care Pre-operative Cleansing | Number of Participants With Positive or Abnormal Skin Cultures on Day of Surgery, Day of Discharge, 30 Days Post-op | day of surgery | 41 Participants |
| Standard of Care Pre-operative Cleansing | Number of Participants With Positive or Abnormal Skin Cultures on Day of Surgery, Day of Discharge, 30 Days Post-op | day of discharge | 21 Participants |
| Standard of Care Pre-operative Cleansing | Number of Participants With Positive or Abnormal Skin Cultures on Day of Surgery, Day of Discharge, 30 Days Post-op | 30 days post-op | 32 Participants |
| 2% Chlorhexidine Gluconate | Number of Participants With Positive or Abnormal Skin Cultures on Day of Surgery, Day of Discharge, 30 Days Post-op | day of surgery | 7 Participants |
| 2% Chlorhexidine Gluconate | Number of Participants With Positive or Abnormal Skin Cultures on Day of Surgery, Day of Discharge, 30 Days Post-op | day of discharge | 9 Participants |
| 2% Chlorhexidine Gluconate | Number of Participants With Positive or Abnormal Skin Cultures on Day of Surgery, Day of Discharge, 30 Days Post-op | 30 days post-op | 25 Participants |
p-value: 0.019Chi-squared