Use of 2% Chlorhexidine Cloths Reduce Surgical Site Infections
NCT ID: NCT02385708
Last Updated: 2019-04-30
Study Results
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View full resultsBasic Information
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COMPLETED
NA
163 participants
INTERVENTIONAL
2015-08-31
2018-06-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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 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.
Treatment Arm
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
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Vanderbilt University
OTHER
Responsible Party
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Steven Klintworth
Research Nurse Specialist IV
Principal Investigators
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Steven R Klintworth, RN
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt Medical Center
Locations
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Vanderbilt University
Nashville, Tennessee, United States
Countries
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References
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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.
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.
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.
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.
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/
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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150309
Identifier Type: -
Identifier Source: org_study_id
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