Effectiveness for Interventions to Minimize Surgical Site Infections

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

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

Study Overview

• Status: Unknown
• Conditions: Infections
• Intervention / Treatment: Procedure: Normal saline pressurized irrigation; Drug: sub-q gentamicin

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75216
      • VANTXHCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 2nd group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dallas VA Medical Center
• Investigators: Principal Investigator: Sean Dineen, MD, VANTXHCS

Publications and helpful links

General Publications

• Dineen SP, Pham TH, Murray BW, Parker BJ, Hartless K, Anthony T, Huerta S. Feasibility of subcutaneous gentamicin and pressurized irrigation as adjuvant strategies to reduce surgical site infection in colorectal surgery: results of a pilot study. Am Surg. 2015 Jun;81(6):573-9.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): September 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: June 29, 2010
• First Submitted That Met QC Criteria: June 29, 2010
• First Posted (Estimate): June 30, 2010

Study Record Updates

• Last Update Posted (Estimate): November 4, 2011
• Last Update Submitted That Met QC Criteria: November 3, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: colorectal surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Gentamicins
• Other Study ID Numbers: #10-046

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No