Effectiveness for Interventions to Minimize Surgical Site Infections
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|ClinicalTrials.gov Identifier: NCT01153191|
Recruitment Status : Unknown
Verified November 2011 by Thomas Anthony, Dallas VA Medical Center.
Recruitment status was: Enrolling by invitation
First Posted : June 30, 2010
Last Update Posted : November 4, 2011
|Condition or disease||Intervention/treatment||Phase|
|Infections||Procedure: Normal saline pressurized irrigation Drug: sub-q gentamicin||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Developing Evidence of Effectiveness for Adjuvant Interventions Designed to Minimize Surgical Site Infections|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||September 2012|
|Estimated Study Completion Date :||December 2012|
Experimental: 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
Procedure: Normal saline pressurized irrigation
Other Name: 1st group
Experimental: 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
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 Name: 2nd group
- Infection rate in colorectal surgeries in each of two treatment arms as compared to historic controls [ Time Frame: 30 days after surgery ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01153191
|United States, Texas|
|Dallas, Texas, United States, 75216|
|Principal Investigator:||Sean Dineen, MD||VANTXHCS|