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Effectiveness for Interventions to Minimize Surgical Site Infections

Information source: Dallas VA Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infections

Intervention: Normal saline pressurized irrigation (Procedure); sub-q gentamicin (Drug)

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Dallas VA Medical Center

Official(s) and/or principal investigator(s):
Sean Dineen, MD, Principal Investigator, Affiliation: VANTXHCS


The purpose of this study is to evaluate two different simple and inexpensive extra treatments during colorectal surgeries to see if this will reduce the rate of post operative infections

Clinical Details

Official title: Developing Evidence of Effectiveness for Adjuvant Interventions Designed to Minimize Surgical Site Infections

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Infection rate in colorectal surgeries in each of two treatment arms as compared to historic controls

Detailed description: The population for inclusion for this study will be drawn from the patients undergoing elective transabdominal colorectal surgery. This population was chosen due to its inherently high rate of superficial-incisional infection. Colorectal procedures stand out as a particularly highrisk surgery with respect to SSI. Several studies have reported rates of infection of 25% or more making colorectal surgeries an excellent opportunity for testing new strategies to reduce SSI. This pilot project seeks to preliminarily evaluate two new strategies that are inexpensive and could be readily incorporated into current practice. The strategies are pressurized irrigation of the superficial surgical wound (above the fascia) and subcutaneous injection of gentamicin into the surgical wound prior to initial skin incision. Comparison will be made between prospectively enrolled patients and historic controls. The hypothesis to be tested is that these interventions will significantly reduce superficial incisional infection rates compared with historic control.


Minimum age: 18 Years. Maximum age: 95 Years. Gender(s): Both.


Inclusion Criteria:

- VA patients getting transabdominal,elective colorectal procedures

- willing and capable of giving self informed consent

Exclusion Criteria:

- patients unable to give informed consent

- emergency colorectal procedures

- transanal procedures

- patients who have contaminated or dirty wounds that would preclude attempts at skin

closure at the conclusion of the procedure

- patients undergoing appendectomy

- patients undergoing intraabdominal procedures not including surgical resection of the

colon or rectum (ie. procedures involving small bowel , stomach)

- patients with pre/op creatinine clearance less than 20ml/min

- patients with known allergy or hypersensitivity to gentamicin

- patients that have received gentamicin within 2 weeks of potential study date

Locations and Contacts

VANTXHCS, Dallas, Texas 75216, United States
Additional Information

Starting date: August 2010
Last updated: November 3, 2011

Page last updated: August 23, 2015

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