NCT04034407 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Kafka-Ritsch R, Birkfellner F, Perathoner A, Raab H, Nehoda H, Pratschke J, Zitt M
Damage control surgery with abdominal vacuum and delayed bowel reconstruction in patients with perforated diverticulitis Hinchey III/IV. J Gastrointest Surg. 2012 Oct;16(10):1915-22. Epub 2012 Jul 28.
Perathoner A, Klaus A, Mühlmann G, Oberwalder M, Margreiter R, Kafka-Ritsch R
Damage control with abdominal vacuum therapy (VAC) to manage perforated diverticulitis with advanced generalized peritonitis--a proof of concept. Int J Colorectal Dis. 2010 Jun;25(6):767-74. doi: 10.1007/s00384-010-0887-8. Epub 2010 Feb 11.

Prospectively Randomized Controlled Trial on Damage Control Surgery for Perforated Diverticulitis With Generalized Peritonitis

Clinical trial NCT04034407 - References