Effectiveness for Interventions to Minimize Surgical Site Infections

Not Applicable

• Conditions: Infections
• Interventions: Drug: sub-q gentamicin; Procedure: Normal saline pressurized irrigation

• Registration Number: NCT01153191
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2010-06-29
• Study First Submitted QC: 2010-06-29
• Study First Posted: 2010-06-30
• Study Start: 2010-08
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-03
• Last Update Posted: 2011-11-04
• Primary Completion: 2012-09
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Sub Q Antibiotic	sub-q gentamicin	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
Pressurized irrigation	Normal saline 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

Primary Outcome Measures

Name	Time	Method
Infection rate in colorectal surgeries in each of two treatment arms as compared to historic controls	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.

Trial Locations

Locations (1)

VANTXHCS; 🇺🇸 Dallas, Texas, United States