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

• Sponsor: Vanderbilt University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02490631
• Collaborator: Sage Products, Inc. (Industry)
• Enrollment: 158
• Location: 1
• Arms: 2
• Actual Duration (Months): 41
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Surgical Site Infections; Post Operative Complication	Drug: 2% chlorhexidine gluconate cloths	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 158 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• 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)
• Actual Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Dec 30, 2018
• Actual Study Completion Date: Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Arm Standard of care pre-operative cleansing with soap and water the night before and morning of surgery
Experimental: Intervention Arm 2% chlorhexidine gluconate cloths the night before and morning of surgery	Drug: 2% chlorhexidine gluconate cloths; Cleansing twice pre-operatively jawline to toes with 2% chlorhexidine gluconate cloths; Other Names: SAGE patient preoperative skin preparation cloths

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

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]

   Skin swabs collected on Day of Surgery, Day of Discharge, 30 days post-op

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

• Vanderbilt University
• Sage Products, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 1, 2018

More Information

Publications

• 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.
• 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
• 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.
• 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. Erratum in: N Engl J Med. 2013 Jun 13;368(24):2341.
• 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.
• 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.
• 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.
• 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. Review.
• Keller RB, Pappas AM. Infection after spinal fusion using internal fixation instrumentation. Orthop Clin North Am. 1972 Mar;3(1):99-111.
• Kostuik JP, Israel J, Hall JE. Scoliosis surgery in adults. Clin Orthop Relat Res. 1973 Jun;(93):225-34.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Elizabeth Card, Nursing Research Consultant, Vanderbilt University
• ClinicalTrials.gov Identifier: NCT02490631
• Other Study ID Numbers: 150310
• First Posted: Jul 7, 2015
• Last Update Posted: Jan 6, 2021
• Last Verified: Feb 1, 2020

• Keywords provided by Elizabeth Card, Nursing Research Consultant, Vanderbilt University: skin flora
• Additional relevant MeSH terms: Infections; Surgical Wound Infection; Postoperative Complications; Chlorhexidine; Chlorhexidine gluconate

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Standard of Care Pre-operative Cleansing	2% Chlorhexidine Gluconate
Arm/Group Description	Standard of care pre-operative cleansing with soap and water the night before and morning of surgery	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
Period Title: Overall Study
STARTED	79	78
COMPLETED	76	75
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	Standard of Care Pre-operative Cleansing	2% Chlorhexidine Gluconate	Total
Arm/Group Description	Standard of care pre-operative cleansing with soap and water the night before and morning of surgery	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	Total of all reporting groups
Overall Participants	76	75	151
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	63	66	64
Sex: Female, Male (Count of Participants)
Female	40 52.6%	34 45.3%	74 49%
Male	36 47.4%	41 54.7%	77 51%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	76 100%	75 100%	151 100%

Outcome Measures

1. Primary Outcome

Title	Participants With Surgical Site Infection Development at 30 Days Post-operative
Description	Evaluation daily using the CDC guidelines, daily measurements and deidentified photos
Time Frame	post op day 30

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care Pre-operative Cleansing	2% Chlorhexidine Gluconate
Arm/Group Description	Standard of care pre-operative cleansing with soap and water the night before and morning of surgery	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
Measure Participants	76	75
Count of Participants [Participants]	5 6.6%	5 6.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care Pre-operative Cleansing, 2% Chlorhexidine Gluconate
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.456
	Comments
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	Number of Participants With Positive or Abnormal Skin Cultures on Day of Surgery, Day of Discharge, 30 Days Post-op
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care Pre-operative Cleansing	2% Chlorhexidine Gluconate
Arm/Group Description	Standard of care pre-operative cleansing with soap and water the night before and morning of surgery	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
Measure Participants	76	75
day of surgery	41 53.9%	7 9.3%
day of discharge	21 27.6%	9 12%
30 days post-op	32 42.1%	25 33.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care Pre-operative Cleansing, 2% Chlorhexidine Gluconate
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.019
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	30 days
Arm/Group Title	Standard of Care Pre-operative Cleansing		2% Chlorhexidine Gluconate
Arm/Group Description	Standard of care pre-operative cleansing with soap and water the night before and morning of surgery		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
All Cause Mortality
	Standard of Care Pre-operative Cleansing		2% Chlorhexidine Gluconate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/75 (0%)
Serious Adverse Events
	Standard of Care Pre-operative Cleansing		2% Chlorhexidine Gluconate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/75 (0%)
Other (Not Including Serious) Adverse Events
	Standard of Care Pre-operative Cleansing		2% Chlorhexidine Gluconate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/75 (0%)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.