Trial | NCT01153191  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    120
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
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 Started
Aug 31
2010
Primary Completion
Sep 30
2012
Anticipated
Study Completion
Dec 31
2012
Anticipated
Last Update
Nov 04
2011
Estimate

Procedure Normal saline pressurized irrigation

same

  • Other names: 1st group

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

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

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

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
No Results Posted