Clinical trial NCT01153191: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Infections
Keywords: colorectal surgery
Lead sponsor: Dallas VA Medical Center
Sponsor class: FED
First posted: 2010-06-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Infection rate in colorectal surgeries in each of two treatment arms as compared to historic controls
timeFrame: 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: VANTXHCS
state: Texas
Study officials:
affiliation: VANTXHCS
name: Sean Dineen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.