Effectiveness for Interventions to Minimize Surgical Site Infections

Infections Clinical Trial

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

Status Enrolling by invitation

Clinical Trial 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

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

• Infection
• Infections
• Surgical Wound Infection

• NCT number: NCT01153191
• Study type: Interventional
• Source: Dallas VA Medical Center
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 2010
• Completion date: December 2012