NCT06365632

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", With a Single Intraperitoneal Use After Surgery in Adult Patients With Acute Phlegmonous Appendicitis

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Research Institute for Physical Chemical Problems of the Belarusian State University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The prospective, randomized, placebo-controlled, single-blind clinical trial of the effectiveness, tolerability and safety of the drug "Antispike, gel, 100 g in a bottle" produced by Unitary Enterprise Unitehprom BGU, Republic of Belarus, in adult patients after surgery for acute phlegmonous appendicitis. Research objectives: * To evaluate the immediate, rapid and long-term results of using Antispike as a drug for preventive adhesions in patients who have a medium and high risk factor for the development of adhesions and are undergoing surgery for acute phlegmonous appendicitis; * Identify the possibility of undesirable effects that may occur when using the drug; * to conduct a comparative assessment of the immediate results of using the drug Antispike as a means of preventing adhesions in patients with minor phlegmonous appendicitis with an effect in the control group, in patients in whom anti-adhesion drugs were not used; * Detailed description of the conditions and method of use of the Antispike drug.

Conditions

• Abdominal Adhesions

Interventions

Type	Name	Description
DRUG	Antispike gel, 100 g in a flask, produced by UNITEHPROM BSU, Republic of Belarus	An antegrade appendectomy is performed, after which 50 to 100 ml of Antispike is applied in a thin layer to the surface of the cecum, the surface of adjacent organs and the parietal peritoneum of the right iliac region. The wound is sutured tightly.
PROCEDURE	antegrade appendectomy	An antegrade appendectomy is performed without using Antispike.

Timeline

• Start date: 2025-03-19
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-04-15
• Last updated: 2025-03-20

Locations

1 site across 1 country: Belarus