Effectiveness for Interventions to Minimize Surgical Site Infections

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Thomas Anthony, Dallas VA Medical Center
ClinicalTrials.gov Identifier:
NCT01153191
First received: June 29, 2010
Last updated: November 3, 2011
Last verified: November 2011
  Purpose

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 Intervention
Infections
Procedure: Normal saline pressurized irrigation
Drug: sub-q gentamicin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Developing Evidence of Effectiveness for Adjuvant Interventions Designed to Minimize Surgical Site Infections

Resource links provided by NLM:


Further study details as provided by Dallas VA Medical Center:

Primary Outcome Measures:
  • Infection rate in colorectal surgeries in each of two treatment arms as compared to historic controls [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: August 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
same
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153191

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

No publications provided

Responsible Party: Thomas Anthony, MD, Dallas VA Medical Center
ClinicalTrials.gov Identifier: NCT01153191     History of Changes
Other Study ID Numbers: #10-046
Study First Received: June 29, 2010
Last Updated: November 3, 2011
Health Authority: United States: Federal Government

Keywords provided by Dallas VA Medical Center:
colorectal surgery

Additional relevant MeSH terms:
Infection
Communicable Diseases
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 15, 2014