A Phase I/II Double-Blind Randomized Controlled Study to Evaluate the Safety and Efficacy of RUT058-60 Lavage Following Abdominal Surgery as an Adjunctive Therapy to Prophylactic Systemic Antibiotics
Study on Investigational Surgical Rinse for Preventing Post-Surgical Infection
Brief description of study.
The purpose of this study is to assess the safety and effectiveness of investigational surgical rinse "RUT058-60" to prevent post-surgical infection in subjects undergoing abdominal surgery
Detailed description of study
The purpose of this study is to assess the safety and effectiveness of investigational surgical rinse "RUT058-60" to prevent post-surgical infection in subjects undergoing abdominal surgery
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Abdominal Surgery
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Age: 100 years or below
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Gender: All
This study investigates the safety and effectiveness of an investigational surgical rinse to prevent infections after abdominal surgery. Abdominal surgery involves operations on the organs in the belly area, such as the stomach or intestines.
Participants in this study will receive either the investigational surgical rinse or a placebo. A placebo is an inactive substance that looks like the investigational rinse but does not contain any active ingredients. The study will compare the outcomes between these two study arms.
- Who can participate: Participants eligible for this study are adults aged 18 to 65 who are scheduled for abdominal surgery. Key eligibility factors include no history of severe allergic reactions and no current infections.
- Study details: Participants will be randomly assigned to receive either the investigational surgical rinse or a placebo during their abdominal surgery. The placebo is an inactive substance that looks like the investigational rinse but does not contain any active ingredients.
Interested in the study?
Select a study center that’s convenient for you, and get in touch with the study team.
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