Effectiveness for Interventions to Minimize Surgical Site Infections

NCT01153191 | Unknown

• 1 other identifier: #10-046
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Infections

Keywords

colorectal surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Pressurized irrigation

EXPERIMENTAL

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

Sub Q Antibiotic

EXPERIMENTAL

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

Interventions

Normal saline pressurized irrigation PROCEDURE

same

Also known as: 1st group

Pressurized irrigation

sub-q gentamicin DRUG

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

Also known as: 2nd group

Sub Q Antibiotic

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• VA patients getting transabdominal,elective colorectal procedures
• willing and capable of giving self informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Dallas VA Medical Center: lead

Study Sites (1)

VANTXHCS

Dallas, Texas, 75216, United States

Location

Related Publications (1)

• 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.

  PMID: 26031269 DERIVED

MeSH Terms

Conditions

Infections

Study Officials

• Sean Dineen, MD

  VANTXHCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: June 30, 2010
• Study Start: August 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 4, 2011

Record last verified: 2011-11

Locations

US (1)