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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01153191
• Other study ID #: #10-046
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 29, 2010
• Last updated: November 3, 2011
• Start date: August 2010
• Est. completion date: December 2012

Study information

• Verified date: November 2011
• Source: Dallas VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

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

Intervention

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

Locations

Country	Name	City	State
United States	VANTXHCS	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Dallas VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection rate in colorectal surgeries in each of two treatment arms as compared to historic controls	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.	30 days after surgery	No