Effectiveness for Interventions to Minimize Surgical Site Infections

NCT ID: NCT01153191

Last Updated: 2011-11-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-12-31

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.

Conditions

Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Normal saline pressurized irrigation

Intervention Type: PROCEDURE

same

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

Group Type: EXPERIMENTAL

sub-q gentamicin

Intervention Type: 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

Interventions

Normal saline pressurized irrigation

same

Intervention Type: PROCEDURE

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

Intervention Type: DRUG

Other Intervention Names

1st group; 2nd group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dallas VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Thomas Anthony

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sean Dineen, MD

Role: PRINCIPAL_INVESTIGATOR

VANTXHCS

Locations

VANTXHCS

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26031269 (View on PubMed)

Other Identifiers

#10-046

Identifier Type: -

Identifier Source: org_study_id