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A Prospective, Randomized, Parallel, Single-blind Clinical Study of the Effectiveness, Tolerability and Safety of the Drug "Anti-spike, Gel, 100 g in Bottles in Package No. 1" Produced by the Republican Unitary Enterprise "Unitekhprom BSU", Belarus, With a Single Intraperitoneal Use After Surgical Interventions in Adult Patients With Acute Phlegmonous Appendicitis (OLTOSPAN-02)
The purpose of the clinical trials is the evaluation of the effectiveness and safety of a single intraperitoneal use of the drug "Antispike, gel, 100 g in a bottle" produced by Unitary Enterprise Unitehprom BSU, Belarus in patients after surgical control of acute phlegmonous appendicitis to prevent abdominal adhesions.
Details
| Lead sponsor | Research Institute for Physical Chemical Problems of the Belarusian State University |
|---|---|
| Phase | Phase 2 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 100 |
| Start date | 2025-03-19 |
| Completion | 2025-12 |
Conditions
- Abdominal Adhesions
Interventions
- Antispike gel, 100 g in a flask, produced by UNITEHPROM BSU, Republic of Belarus
- antegrade appendectomy
Primary outcomes
- Number of patients with acute phlegmonous appendicitis cured — from surgery to 3 weeks
Number of patients cured
Countries
Belarus