Clinical trial NCT02385708
Conditions: Surgical Site Infection
Sponsor: Vanderbilt University
Start date: 2015-08-01; Completion date: 2018-06-21
Enrollment: 163 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Use of 2% chlorhexidine gluconate cloths pre-operatively and daily post-operatively jaw line to toes will decrease surgical site infections (SSI) by 30% when compared to patients who receive routine standard of care (use of chlorhexidine cloths night before surgery and morning of surgery).

Detailed description:
Patients undergoing colorectal surgery will be randomized in a 1:1 fashion into two groups. One will be standard of care using 2% Chlorhexidine Gluconate wipes night before surgery and morning if surgery. The second group will be randomized into the study arm using 2% Chlorhexidine Gluconate clothes from jaw line to toes night before surgery, morning of surgery and daily post operative. Skin cultures will be obtained at time of consent, prior to surgical procedure before surgical scrub and draping, post operative day 4 and at 30 day follow up visit. Incision lines will be assessed daily by study staff for signs of surgical site infection utilizing the CDC's 3 definitions of surgical site infections, superficial incisional SSI, deep incisional SSI, and organ space SSI.

Arms: arm 1: Patients will perform the current standard of care treatment using 2% Chlorohexidine Gluconate Cloths on the abdomen and buttocks prior to colorectal surgery night before surgery and morning of surgery arm 2: Patients will perform treatment with 2% Chlorohexidine Gluconate cloths chin to toe night before and morning of surgery then daily post operative until post op day 4 or discharge
Interventions: intervention 1: 2% Chlorohexidine Gluconate Standard of Care intervention 2: 2% Chlorohexidine Gluconate Chin to Toe
Intervention descriptions: intervention 1: Patients will perform the current standard of care treatment using 2% Chlorohexidine Gluconate Cloths on the abdomen and buttocks prior to colorectal surgery night before surgery and morning of surgery. intervention 2: Patients will perform treatment with 2% Chlorohexidine Gluconate cloths chin to toe night before and morning of surgery then daily post operative until post op day 4 or discharge

Protocol documents:
Prot_SAP_000.pdf: 
Version:  09/14/2017 
1 
 
 
 
 
 
Protocol Title 
 
A Randomized Controlled Trial of 2% Chlorhexidine 
Gluconate Skin Preparation Cloths for the Prevention 
of Post-Operative Surgical Site Infections in 
Colorectal Patients 
 
 
Principal Investigator 
Steven Klintworth, R.N. CCRP 
Research Nurse Specialist IV 
1211 21st Avenue South 
711 Medical Arts Building 
Nashville, TN 37212-1050 
615-936-5354 
 
 
Sub Investigators  
Matthew McEvoy, M.D. 
Edward Sherwood, M.D., Ph.D. 
Timothy Geiger, M.D.  
Elizabeth Card, MSN, APN, FNP-BC, 
Damon Michaels, BS, CCRP 
 
 
 
 
 
Confidential 
 
 
 
Department of Anesthesiology 
Vanderbilt University School of Medicine 
 
 
 


Version:  09/14/2017 
2 
 
 
 
Table of Contents: 
 
1. Background and Significance 
2. Hypothesis 
3. Study Objectives 
4. Methods 
5. Patient Population 
6. Enrollment 
7. Inclusion/Exclusion Criteria 
8. Data Collection 
9. Reporting of Adverse Events or Unanticipated Problems involving Risk to 
Participants or Others: 
10. Statistical Plan 
11. Privacy/Confidentiality Issues 
12. Follow-up and Record Retention 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Version:  09/14/2017 
3 
 
1. 
Background and Significance:   
Surgical site infection (SSI) following colorectal surgery is a frequent complication and 
results in higher morbidity, mortality and healthcare costs. SSI following adult colorectal 
surgery is a frequent complication that has been reported to occur in 5%-30% of cases 
nationally. Vanderbilt’s SSI reported rate of infections in colorectal surgeries is currently 8%. 
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. Vanderbilt 
performs approximately 1,000 colorectal cases per year.  
 
The New CDC-definitions for surveillance of surgical site infections (1992) take into account 
3 classes of surgical site infections (SSI): superficial incisional SSI, deep incisional SSI, and 
organ/space SSI. The most prevalent host-related risk factors for development of SSI are 
advanced age, morbid obesity, disease severity, an ASA score > 2, prolonged preoperative 
hospital stay, and infection at distal sites. Microbial contamination of the surgical site occurs 
mainly during the surgical intervention.  
 
Although exogenous contamination from the surgical suite may be of concern, especially in 
clean operations, most surgical site infections are caused by microorganisms of the patient's 
own skin flora. SSI rates vary according to the type and duration of the surgical procedure. 
Proper surgical technique is probably the most important factor in the prevention of SSI.  
 
Modification of patient risk factors should be attempted whenever possible through use of 
adequate protocols for antimicrobial prophylaxis with antibiotics should be followed. Routine 
surveillance of surgical site infections is beneficial for SSI prevention and early detection. 
Additional prevention aimed at decreasing number of microorganisms on patient’s skin pre-
operatively may decrease rates of SSI. Prior studies have reported daily use of 2% 
chlorhexidine gluconate cloths has decreased rates of nosocomial bloodstream infections 
in those with central line catheters. Another study reported decreasing SSIs up to 50% when 
nursing staff instituted utilization of 2% chlorhexidine gluconate cloths pre-op and daily post-
op cleansing in-hospital. However, use of chlorhexidine cloths pre-operatively has not been 
routinely instituted. Many hospitals and service lines do not have a protocol for their use. 
Therefore study of such a population may prove worthy, as currently VUMC colorectal 
patients use chlorhexidine cloths preoperative on the abdomen, groin and buttocks the night 
before surgery and again the morning of surgery.  
 
This study proposes a randomized, controlled trial of colorectal patients of 2% chlorhexidine 
gluconate skin preparation cloths for the prevention of post op surgical site infections in 
colorectal patients.  
 
2. 
Hypothesis: 
Use of 2% chlorhexidine gluconate cloths pre-operatively and daily post-operatively 
(neckline to toes) will decrease surgical site infections (SSI) by 30% (study group) when 
compared to patients who use chlorhexidine cloths night before surgery and morning of 
surgery (control group). 
 
 
3. 
Study Objectives: 
 
Randomize consented patients pre-operatively to either the study group (of 2% 
chlorhexidine gluconate cloths pre-op night before day of surgery and daily post-


Version:  09/14/2017 
4 
 
op cleansing) or the control group with follow-up through discharge for evaluation 
of SSI 
 
Evaluation for SSI development at 30 day (+/-) post-op visit. 
 
Measure change in skin flora by comparing skin swab cultures of those in the study 
group versus those in the control group at time of consent (baseline), pre-
operative, day 4 post-operative, or day  of discharge whichever comes first, and at 
the 30 day follow up.  
 
4. 
Methods: 
Patients scheduled for colorectal surgery will be evaluated and approached for interest. 
Consented subjects will be randomized in a 1:1 ratio (approximately 75 subjects per 
treatment arm) through a block randomization table. Those enrolled into the study arm will 
receive the 2% chlorhexidine gluconate cloths and instructions for use from research 
personal. The subject will wash themselves neck to toe using Chlorhexidine gluconate wipes 
per study instructions the night before. Study staff will perform the CHG wipe application on 
the day of surgical procedure. They will then receive post-op daily skin cleansings per 
protocol by research personnel until post op day 4 or discharge from the hospital, whichever 
comes first.  
 
Subjects randomized to the control arm will receive Chlorhexidine gluconate wipes and 
instructions for use per the previous colorectal surgical policy (prior to September 2017).   
 
On the day of surgery all subjects will have an abdominal skin swab culture taken after 
cleansing with Chlorhexidine gluconate wipes.  We will also obtain abdominal skin swab 
cultures at site of incision  post-op day 4, or  day  of discharge and at the 30 day follow up 
(+/- 7 days). 
 
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. A high definition picture will be 
taken each day of the incision line to further document signs of SSI development (pictures 
will not have any patient identifiable information) Additional evaluation will take place at the 
30 day post-op visit. Measured change in skin flora will be performed by comparing skin 
swab cultures of control group vs study group.   
 
Subjects will be withdrawn from the study if they are transferred to a hospital unit that is not 
one of the acute care post-operative hospital units (eg:  not on 3/4 RW or 9 N/S). 
 
Procedure 
  
  
  
  
  
  
  
Study Day 
Screening 
Surgical 
Procedure 
POD 
1 
POD 
2 
POD 
3 
POD 4 
or 
Dischar
ge 
30 (+/- 14 
days) 
Follow-up 
Written informed consent/HIPAA 
X 
  
  
  
  
  
  
Inclusion/Exclusion Criteria 
X 
  
  
  
  
  
  
Randomization Number Assigned 
X 
  
  
  
  
  
  
Medical History 
X 
  
  
  
  
  
  
Urine Pregnancy Test 
  
SOC 
  
  
  
  
  
Chlorhexidine gluconate skin preparation 
(Research Arm)  
X1 
X 
X 
X 
X 
X 
  


Version:  09/14/2017 
5 
 
Chlorhexidine gluconate skin preparation (control) 
X 
X 
  
  
  
  
  
CULTURE OTHER SOURCE (CDM 60930104 - 
CPT 87070)  
X 
X3 
  
  
  
X 
X 
Height / Weight 
X 
  
  
  
  
  
  
Vital Signs 
X 
X 
X 
X 
X 
X 
X  
Post-surgical assessments  
  
X2 
X2 
X2 
X2 
X2 
X2 
Post-surgical photograph 
  
 
X 
X 
X 
X 
X 
Blinded assessment of photographs 
  
  
  
  
  
  
X 
Assess Adverse events 
X 
X 
X 
X 
X 
X 
X 
Prior Medication Recording 
X 
  
  
  
  
  
  
Concomitant Medication Recording 
  
X 
X 
X 
X 
X 
X 
  
  
  
  
  
  
  
  
1-Participants will be given supplies at screening.  Application will be done by 
participant on the evening prior to surgery. 
2-Post-surgical assessments include documentation of any complications.  
3-Culture taken after clorhexedine wipes; before surgical scrub and draping  
 
5. 
Patient Population: 
Colorectal surgical patients at Vanderbilt University Medical Center 
 
6. 
Enrollment: 
150 patients will be enrolled.  
 
7. 
Inclusion/Exclusion Criteria: 
 
 
Inclusion Criteria 
1. Patients > 18 years old scheduled for a colorectal surgical procedure ASA>2 OR 
pre-operatively hospitalized 
 
Exclusion Criteria 
1. Unable to consent 
2. Known allergy to any of the ingredients contained in SAGE chlorhexidine gluconate 
cloths 
3. Current infection or history of abdominal infections. 
4. Patients on chronic steroids or immunosuppressive medications.  
 
8. 
Data Collection: 
Data regarding demographics, health history and status, surgical course and hospitalization 
will be collected and entered into an electronic database. Patient data will be de-identified 
once it’s entered into the database. Shared data will always be de-identified and accessed 
through Redcap, a secure web-based system. 
 
9. 
Reporting of Adverse Events or Unanticipated Problems involving Risk to 
Participants or Others: 
Events determined by the Principal Investigator (PI) to be unanticipated problems involving 
risks to subjects will be reported by the PI or sub-investigator to the IRB within 10 working 
days of the Investigator's knowledge of the problem. 


Version:  09/14/2017 
6 
 
 
10. 
Statistical Plan: 
We are planning a study of independent cases and controls with 1 control(s) per case.  Prior 
data indicate the rate of infection in the control group (those with risk factors, including 
superficial SSI) is 0.5, then just 150 are needed to detect a 50% or greater reduction, with 
80% power. We can also design a statistical analysis plan that uses the grade of SSI instead 
of binary yes/no to indicate presence of SSI. This should increase the power as well, for 
instance, if the SAGE cloths reduce the severity of (but does not completely prevent) 
infection in some patients. 
 
11. 
Privacy/Confidentiality Issues 
All reasonable efforts will be made to keep a patient’s protected health information (PHI) 
private and confidential.  There will be limited access to electronic medical records and de-
identification of all records.  Federal privacy guidelines will be followed when using or 
sharing any protected health information.  
 
Data will be stored in Redcap, a secure web-based database conforming to the latest 
Vanderbilt IS security policies. Data from the study will be reported only in the aggregate. 
 
A member of the research team at Vanderbilt University will travel to the other sites to assist 
with data collection. Under the supervision of each site’s PI, Vanderbilt research team 
members will view research records and collect data as identified above. Medical records 
will be stored separately from the data and remain on-site. All de-identified data-points will 
be entered directly into Redcap, a secure web-based database. No identified information 
will leave the site.  
 
 
All study staff have completed employee education regarding patient confidentiality and 
have completed Human Subjects protection education (CITI course) as specified by the 
Vanderbilt IRB. 
 
Through these interventions, we expect risks to privacy to be minimized. 
 
12. 
Follow-up and Record Retention 
Research Records will be retained by the Department of Anesthesiology for a period of six 
(6) years after the submission of the final report and close-out procedures on the research 
project for which the Research Records were prepared.  
 
The retention of the original Research Records shall be the responsibility of the Principal 
Investigator on behalf of Department of Anesthesiology, but at all times shall remain the 
property of Department of Anesthesiology, unless otherwise specified by law, regulation or 
agreement. 
 
 
 
 


Version:  09/14/2017 
7 
 
 
 
 
References 
Fry, D.E. (2013, December 19).  The prevention of surgical site infection in elective colon 
surgery. Scientifica (Cairo), 2013: 896297. doi:  10.1155/2013/896297. 
PMCID: PMC3881664. 
Grade, M., Quintel, M. and Ghadimi, B. M. (2011, June). Standard perioperative management in 
gastrointestinal surgery. Langenbeck’s Archives of Surgery, 396(5): 591–
606.  Doi:  10.1007/s00423-011-0782-y.  PMCID: PMC3101361 
Kobayashi M, Mohri Y, Inoue Y, Okita Y, Miki C, Kusunoki M. (2008, Jun). Continuous 
follow-up of surgical site infections for 30 days after colorectal surgery. World Journal of 
Surgery, 32(6),1142-1146. Doi: 10.1007/s00268-008-9536-6. PubMed PMID: 18338205. 
Konishi T, Watanabe T, Kishimoto J, Nagawa H. (2006). Elective colon and rectal surgery differ 
in risk factors for wound infection: results of prospective surveillance. Annals of Surgery, 
244(5), 758-763. PubMed PMID: 17060769; PubMed Central PMCID: PMC1856583. 
National Collaborating Centre for Women's and Children's Health (UK). Surgical Site Infection: 
Prevention and Treatment of Surgical Site Infection. London: RCOG Press; 2008 Oct. 
(NICE Clinical Guidelines, No. 74.)Available from: 
http://www.ncbi.nlm.nih.gov/books/NBK53731/ 
Smith RL, Bohl JK, McElearney ST, Friel CM, Barclay MM, Sawyer RG, Foley EF. (2004). 
Wound infection after elective colorectal resection. Annals of Surgery, 239(5), 599-605; 
discussion 605-7. PubMed PMID: 15082963; PubMed Central PMCID: PMC1356267 


Version:  09/14/2017 
8 
 
Stulberg JJ, Delaney CP, Neuhauser DV, Aron DC, Fu P, Koroukian SM. (2010).  Adherence to 
surgical care improvement project measures and the asiation with postoperative 
infections. JAMA, 303(24), 2479-2485. doi:10.1001/jama.2010.841. 
Watanabe M, Suzuki H, Nomura S, Maejima K, Chihara N, Komine O, Mizutani S, Yoshino M, 
Uchida E. (2014). Risk factors for surgical site infection in emergency colorectal surgery: 
a retrospective analysis. Surgical Infections. 15(3), 256-261. Doi: 10.1089/sur.2012.154. 
PubMed PMID: 24810804.