NCT01153191

Effectiveness for Interventions to Minimize Surgical Site Infections

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Dallas VA Medical Center · Federal
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Infections

Interventions

Type	Name	Description
PROCEDURE	Normal saline pressurized irrigation	same
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

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2010-06-30
• Last updated: 2011-11-04

Locations

1 site across 1 country: United States