2% Chlorhexidine Gluconate Skin Cloths to Prevent SSI in Spine Surgery Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, Hospital |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 19 - 90 |
| Updated: | 4/28/2018 |
| Start Date: | August 2015 |
| End Date: | January 2019 |
| Contact: | Elizabeth Card, MSN |
| Email: | elizabeth.b.card@vanderbilt.edu |
| Phone: | (615)875-4611 |
A Randomized Controlled Trial of 2% Chlorhexidine Gluconate Skin Preparation Cloths for the Prevention of Post op Surgical Site Infections in Spine Patients (Decrease SSI or DeSSI)
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).
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).
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.
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.
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.
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Phone: (615)875-4611
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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