Enrolling by invitation NCT07048899
Irrisept in Emergency General Surgery Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chlorhexidine, Normal Saline.
- Who it may be relevant to
- Registry conditions: Emergency Surgery, Surgical Site Infections. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Irrisept Irrigation in Emergency General Surgery Cases on SSI Rates
Overview
This is a single institution, randomized study conducted to determine if irrigation with Irrisept in emergency general surgery patients results in lower surgical site infections compared to normal saline irrigation.
Interventions
- Drug Chlorhexidine
Intraperitoneal irrigation with Irrisept solution - Drug Normal Saline
Intraperitoneal irrigation with normal saline
Primary outcome measures
- Surgical Site Infection Rate [Time frame: Time of enrollment to 30 days]
Secondary outcome measures (3)
- Length of Stay [Time frame: From date of admission until date of discharge from the hospital, assessed up to 30 days post-operatively]
- Incidence of SSI and surgical wound class with the use of Irrisept [Time frame: Time of enrollment to 30 days]
- Readmission Rates due to SSI [Time frame: From day of surgery to 30 days]
Eligibility criteria
Inclusion criteria
- All patients (\>18 years old at time of enrollment) who are hospitalized at UT Tyler and undergo an open (or conversion to open) wound class 2-4 surgical procedure for an emergent surgical condition.
Exclusion criteria
- Those \<18 years of age
- Pressure wounds
- Superficial abscesses (as primary diagnosis)
- intra-abdominal abscess due to previous technical failure
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- UT Health Tyler — Tyler
Identifiers
NCT: NCT07048899 · 2024-122