Effectiveness for Interventions to Minimize Surgical Site Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01153191
Recruitment Status : Unknown
Verified November 2011 by Thomas Anthony, Dallas VA Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : June 30, 2010
Last Update Posted : November 4, 2011
Information provided by (Responsible Party):
Thomas Anthony, Dallas VA Medical Center

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Infections Procedure: Normal saline pressurized irrigation Drug: sub-q gentamicin Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Developing Evidence of Effectiveness for Adjuvant Interventions Designed to Minimize Surgical Site Infections
Study Start Date : August 2010
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pressurized irrigation
first group-After closure of patients abdominal wall fascia, Hydrostatic irrigation with 3 liters of normal saline with Simpulse Solo irrigation system (Davol) at less than 15PSI will be applied to subcutaneous tissues prior to closure
Procedure: Normal saline pressurized irrigation
Other Name: 1st group

Experimental: Sub Q Antibiotic
second group of patients will receive 2mg/lg of gentamicin in 20 ml of sterile saline injected into the superficial tissues above the ABD wall fascia prior to initial incision
Drug: sub-q gentamicin
2mg/kg of gentamicin in 20 ml of sterile saline up to max dose of 120mg injected above the abdominal wall fascia- the length of the incision will be marked and injection made with intent being to evenly distribute the volume of injection in the subcutaneous tissues in immediate vicinity of and prior to the initial incision- analogous to the technique employed when using local anesthetic
Other Name: 2nd group

Primary Outcome Measures :
  1. Infection rate in colorectal surgeries in each of two treatment arms as compared to historic controls [ Time Frame: 30 days after surgery ]
    pilot study to evaluate 1. pressurized irrigation of the superficial surgical wound after fascial closure in 40 patients and 2. subcutaneous gentamicin into the surgical area prior to initial incision in 40 patients and compare rates of surgical site infections after 30 days to historic controls.

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01153191

United States, Texas
Dallas, Texas, United States, 75216
Sponsors and Collaborators
Dallas VA Medical Center
Principal Investigator: Sean Dineen, MD VANTXHCS

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Thomas Anthony, MD, Dallas VA Medical Center Identifier: NCT01153191     History of Changes
Other Study ID Numbers: #10-046
First Posted: June 30, 2010    Key Record Dates
Last Update Posted: November 4, 2011
Last Verified: November 2011

Keywords provided by Thomas Anthony, Dallas VA Medical Center:
colorectal surgery

Additional relevant MeSH terms:
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action