Use of 2% Chlorhexidine Cloths Reduce Surgical Site Infections

NCT02385708 | Completed Results

• 1 other identifier: 150309
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

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).

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

Drug: 2% Chlorohexidine Gluconate Standard of Care

Treatment Arm

ACTIVE COMPARATOR

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

Drug: 2% Chlorohexidine Gluconate Chin to Toe

Interventions

2% Chlorohexidine Gluconate Standard of Care DRUG

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.

Also known as: 2% Chlorhexidine Gluconate

Standard of Care

2% Chlorohexidine Gluconate Chin to Toe DRUG

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

Also known as: 2% Chlorohexidine Gluconate

Treatment Arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37212, United States

Location

Related 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.

  PMID: 24455434 BACKGROUND

• 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.

  PMID: 21448724 BACKGROUND

• 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.

  PMID: 18338205 BACKGROUND

• 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. doi: 10.1097/01.sla.0000219017.78611.49.

  PMID: 17060769 BACKGROUND

• 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. Available from http://www.ncbi.nlm.nih.gov/books/NBK53731/

  PMID: 21698848 BACKGROUND

• 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. doi: 10.1097/01.sla.0000124292.21605.99.

  PMID: 15082963 BACKGROUND

• 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.

  PMID: 20571014 BACKGROUND

• 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.

  PMID: 24810804 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

chlorhexidine gluconate

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Steven Klintworth
• Organization: Vanderbilt University Medical Center

steven.klintworth@vumc.org

615-936-3298

Study Officials

• Steven R Klintworth, RN

  Vanderbilt Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Nurse Specialist IV

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 11, 2015
• Study Start: August 1, 2015
• Primary Completion: June 21, 2018
• Study Completion: June 21, 2018
• Last Updated: April 30, 2019
• Results First Posted: April 24, 2019

Record last verified: 2019-04

Locations

US (1)