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Effectiveness for Interventions to Minimize Surgical Site Infections

Primary Purpose

Infections

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Normal saline pressurized irrigation
sub-q gentamicin
Sponsored by
Dallas VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections focused on measuring colorectal surgery

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VANTXHCS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pressurized irrigation

Sub Q Antibiotic

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 29, 2010
Last Updated
November 3, 2011
Sponsor
Dallas VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01153191
Brief Title
Effectiveness for Interventions to Minimize Surgical Site Infections
Official Title
Developing Evidence of Effectiveness for Adjuvant Interventions Designed to Minimize Surgical Site Infections
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dallas VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections
Keywords
colorectal surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pressurized irrigation
Arm Type
Experimental
Arm Description
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
Arm Title
Sub Q Antibiotic
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Normal saline pressurized irrigation
Other Intervention Name(s)
1st group
Intervention Description
same
Intervention Type
Drug
Intervention Name(s)
sub-q gentamicin
Other Intervention Name(s)
2nd group
Intervention Description
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
Primary Outcome Measure Information:
Title
Infection rate in colorectal surgeries in each of two treatment arms as compared to historic controls
Description
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.
Time Frame
30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Dineen, MD
Organizational Affiliation
VANTXHCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
VANTXHCS
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26031269
Citation
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.
Results Reference
derived

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Effectiveness for Interventions to Minimize Surgical Site Infections

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