Use of 2% Chlorhexidine Cloths Reduce Surgical Site Infections

Surgical Site Infection Clinical Trial

Official title:

A Randomized Controlled Trial of 2% Chlorhexidine Gluconate Skin Preparation Cloths for the Prevention of Post-Operative Surgical Site Infections in Colorectal Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02385708
• Other study ID #: 150309
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: June 21, 2018

Study information

• Verified date: April 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: June 21, 2018
• Est. primary completion date: June 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1. Patients > 18 years old scheduled for a colorectal surgical procedure ASA>2 OR pre-operatively hospitalized

Exclusion Criteria:

• Unable to consent

• Known allergy to any of the ingredients contained in SAGE chlorhexidine gluconate cloths

• Current infection or history of abdominal infections.

• Patients on chronic steroids or immunosuppressive medications.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• 2% Chlorohexidine Gluconate Standard of Care
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.
• 2% Chlorohexidine Gluconate Chin to Toe
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

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (8)

Fry DE. The prevention of surgical site infection in elective colon surgery. Scientifica (Cairo). 2013;2013:896297. doi: 10.1155/2013/896297. Epub 2013 Dec 19. Review. — View Citation

Grade M, Quintel M, Ghadimi BM. Standard perioperative management in gastrointestinal surgery. Langenbecks Arch Surg. 2011 Jun;396(5):591-606. doi: 10.1007/s00423-011-0782-y. Epub 2011 Mar 30. Review. — View Citation

Kobayashi M, Mohri Y, Inoue Y, Okita Y, Miki C, Kusunoki M. Continuous follow-up of surgical site infections for 30 days after colorectal surgery. World J Surg. 2008 Jun;32(6):1142-6. doi: 10.1007/s00268-008-9536-6. — View Citation

Konishi T, Watanabe T, Kishimoto J, Nagawa H. Elective colon and rectal surgery differ in risk factors for wound infection: results of prospective surveillance. Ann Surg. 2006 Nov;244(5):758-63. — View Citation

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. Wound infection after elective colorectal resection. Ann Surg. 2004 May;239(5):599-605; discussion 605-7. — View Citation

Stulberg JJ, Delaney CP, Neuhauser DV, Aron DC, Fu P, Koroukian SM. Adherence to surgical care improvement project measures and the association with postoperative infections. JAMA. 2010 Jun 23;303(24):2479-85. doi: 10.1001/jama.2010.841. — View Citation

Watanabe M, Suzuki H, Nomura S, Maejima K, Chihara N, Komine O, Mizutani S, Yoshino M, Uchida E. Risk factors for surgical site infection in emergency colorectal surgery: a retrospective analysis. Surg Infect (Larchmt). 2014 Jun;15(3):256-61. doi: 10.1089/sur.2012.154. Epub 2014 May 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Surgical Site Infections	Number of participants who had surgical site infection development at 30 day post operative visit based on Center for Disease Control Criteria for Defining A Surgical Site Infection (SSI), 2011.	30 days