2% Chlorhexidine Gluconate Skin Cloths to Prevent SSI in Spine Surgery Patients

NCT02490631 | Completed Phase 3 Results DMC

• 1 other identifier: 150310
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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).

Conditions

Surgical Site Infections; Post Operative Complication

Keywords

skin flora

Outcome Measures

Primary Outcomes (1)

• Participants With Surgical Site Infection Development at 30 Days Post-operative

  Evaluation daily using the CDC guidelines, daily measurements and deidentified photos

  post op day 30

Secondary Outcomes (1)

• 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

Study Arms (2)

Control Arm

NO INTERVENTION

Standard of care pre-operative cleansing with soap and water the night before and morning of surgery

Intervention Arm

EXPERIMENTAL

2% chlorhexidine gluconate cloths the night before and morning of surgery

Drug: 2% chlorhexidine gluconate cloths

Interventions

2% chlorhexidine gluconate cloths DRUG

Cleansing twice pre-operatively jawline to toes with 2% chlorhexidine gluconate cloths

Also known as: SAGE patient preoperative skin preparation cloths

Intervention Arm

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead
• Sage Products, Inc.: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (19)

• 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.

  PMID: 8547767 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 8893444 BACKGROUND

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  PMID: 5012590 BACKGROUND

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  PMID: 4722945 BACKGROUND

• 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.

  PMID: 4584242 BACKGROUND

• 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.

  PMID: 9507627 BACKGROUND

• 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.

  PMID: 2053001 BACKGROUND

• 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.

  PMID: 12650399 BACKGROUND

• 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.

  PMID: 8539047 BACKGROUND

• 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.

  PMID: 8059266 BACKGROUND

• 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.

  PMID: 17436915 BACKGROUND

• 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.

  PMID: 18303461 BACKGROUND

• 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.

  PMID: 20066445 BACKGROUND

• 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.

  PMID: 19478664 BACKGROUND

• 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.

  PMID: 19494763 BACKGROUND

• 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.

  PMID: 22889522 BACKGROUND

• 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.

  PMID: 23388005 BACKGROUND

• 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.

  PMID: 23363666 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

larger sample size needed to examine the relationship between normal skin cultures in the Chlorhexidine arm vs control and development of surgical site infections by day 30.

Results Point of Contact

• Title: Elizabeth Card
• Organization: Vanderbilt University Medical Center

elizabeth.b.card@vumc.org

615-875-4611

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nursing Research Consultant

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: July 7, 2015
• Study Start: August 1, 2015
• Primary Completion: December 30, 2018
• Study Completion: December 31, 2018
• Last Updated: January 6, 2021
• Results First Posted: February 25, 2020

Record last verified: 2020-02

Locations

US (1)