Clinical trial NCT02490631: 2% Chlorhexidine Gluconate Skin Cloths to Prevent SSI in Spine Surgery Patients
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgical Site Infections
Post Operative Complication
Keywords: skin flora
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Sage Products, Inc.
First posted: 2015-07-07
Enrollment: 158
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Participants With Surgical Site Infection Development at 30 Days Post-operative
timeFrame: post op day 30
Secondary outcomes:
measure: Number of Participants With Positive or Abnormal Skin Cultures on Day of Surgery, Day of Discharge, 30 Days Post-op
timeFrame: Day of Surgery, Day of Discharge, 30 days post-op
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
citation: Abbey DM, Turner DM, Warson JS, Wirt TC, Scalley RD. Treatment of postoperative wound infections following spinal fusion with instrumentation. J Spinal Disord. 1995 Aug;8(4):278-83. doi: 10.1097/00002517-199508040-00003.
citation: Balderston RA, Blumberg K (1991) Infection in spine surgery. In: Balderston RA, An HS (eds) Complications in spinal surgery. WB Saunders, Philadelphia, pp 157-168
citation: Glassman SD, Dimar JR, Puno RM, Johnson JR. Salvage of instrumental lumbar fusions complicated by surgical wound infection. Spine (Phila Pa 1976). 1996 Sep 15;21(18):2163-9. doi: 10.1097/00007632-199609150-00021.
citation: Keller RB, Pappas AM. Infection after spinal fusion using internal fixation instrumentation. Orthop Clin North Am. 1972 Mar;3(1):99-111. No abstract available.
citation: Kostuik JP, Israel J, Hall JE. Scoliosis surgery in adults. Clin Orthop Relat Res. 1973 Jun;(93):225-34. doi: 10.1097/00003086-197306000-00022. No abstract available.
citation: Lonstein J, Winter R, Moe J, Gaines D. Wound infection with Harrington instrumentation and spine fusion for scoliosis. Clin Orthop Relat Res. 1973 Oct;(96):222-33. No abstract available.
citation: Roberts FJ, Walsh A, Wing P, Dvorak M, Schweigel J. The influence of surveillance methods on surgical wound infection rates in a tertiary care spinal surgery service. Spine (Phila Pa 1976). 1998 Feb 1;23(3):366-70. doi: 10.1097/00007632-199802010-00016.
citation: West JL 3rd, Ogilvie JW, Bradford DS. Complications of the variable screw plate pedicle screw fixation. Spine (Phila Pa 1976). 1991 May;16(5):576-9. doi: 10.1097/00007632-199105000-00016.
citation: Olsen MA, Mayfield J, Lauryssen C, Polish LB, Jones M, Vest J, Fraser VJ. Risk factors for surgical site infection in spinal surgery. J Neurosurg. 2003 Mar;98(2 Suppl):149-55.
citation: Calderone RR, Garland DE, Capen DA, Oster H. Cost of medical care for postoperative spinal infections. Orthop Clin North Am. 1996 Jan;27(1):171-82.
citation: Davis H. Increasing rates of cervical and lumbar spine surgery in the United States, 1979-1990. Spine (Phila Pa 1976). 1994 May 15;19(10):1117-23; discussion 1123-4. doi: 10.1097/00007632-199405001-00003.
citation: Patel N, Bagan B, Vadera S, Maltenfort MG, Deutsch H, Vaccaro AR, Harrop J, Sharan A, Ratliff JK. Obesity and spine surgery: relation to perioperative complications. J Neurosurg Spine. 2007 Apr;6(4):291-7. doi: 10.3171/spi.2007.6.4.1.
citation: Rihn JA, Lee JY, Ward WT. Infection after the surgical treatment of adolescent idiopathic scoliosis: evaluation of the diagnosis, treatment, and impact on clinical outcomes. Spine (Phila Pa 1976). 2008 Feb 1;33(3):289-94. doi: 10.1097/BRS.0b013e318162016e.
citation: Pull ter Gunne AF, van Laarhoven CJ, Cohen DB. Incidence of surgical site infection following adult spinal deformity surgery: an analysis of patient risk. Eur Spine J. 2010 Jun;19(6):982-8. doi: 10.1007/s00586-009-1269-1. Epub 2010 Jan 12.
citation: Pull ter Gunne AF, Cohen DB. Incidence, prevalence, and analysis of risk factors for surgical site infection following adult spinal surgery. Spine (Phila Pa 1976). 2009 Jun 1;34(13):1422-8. doi: 10.1097/BRS.0b013e3181a03013.
citation: Eiselt D. Presurgical skin preparation with a novel 2% chlorhexidine gluconate cloth reduces rates of surgical site infection in orthopaedic surgical patients. Orthop Nurs. 2009 May-Jun;28(3):141-5. doi: 10.1097/NOR.0b013e3181a469db.
citation: Karki S, Cheng AC. Impact of non-rinse skin cleansing with chlorhexidine gluconate on prevention of healthcare-associated infections and colonization with multi-resistant organisms: a systematic review. J Hosp Infect. 2012 Oct;82(2):71-84. doi: 10.1016/j.jhin.2012.07.005. Epub 2012 Aug 11.
citation: Climo MW, Yokoe DS, Warren DK, Perl TM, Bolon M, Herwaldt LA, Weinstein RA, Sepkowitz KA, Jernigan JA, Sanogo K, Wong ES. Effect of daily chlorhexidine bathing on hospital-acquired infection. N Engl J Med. 2013 Feb 7;368(6):533-42. doi: 10.1056/NEJMoa1113849.
citation: Milstone AM, Elward A, Song X, Zerr DM, Orscheln R, Speck K, Obeng D, Reich NG, Coffin SE, Perl TM; Pediatric SCRUB Trial Study Group. Daily chlorhexidine bathing to reduce bacteraemia in critically ill children: a multicentre, cluster-randomised, crossover trial. Lancet. 2013 Mar 30;381(9872):1099-106. doi: 10.1016/S0140-6736(12)61687-0. Epub 2013 Jan 28.