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Pressurized irrigation for Infections
N/A
Waitlist Available
Led By Sean Dineen, MD
Research Sponsored by Dallas VA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
VA patients getting transabdominal,elective colorectal procedures
willing and capable of giving self informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after surgery
Awards & highlights
Study 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
Eligible Conditions
- Infections
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Infection rate in colorectal surgeries in each of two treatment arms as compared to historic controls
Trial Design
2Treatment groups
Experimental Treatment
Group I: Sub Q AntibioticExperimental Treatment1 Intervention
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 II: Pressurized irrigationExperimental Treatment1 Intervention
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
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Who is running the clinical trial?
Dallas VA Medical CenterLead Sponsor
34 Previous Clinical Trials
4,715 Total Patients Enrolled
2 Trials studying Infections
381 Patients Enrolled for Infections
Sean Dineen, MDPrincipal InvestigatorVANTXHCS
Frequently Asked Questions
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