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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

NCT06365632 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-03-20

No results posted yet for this study

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.

Conditions

  • Abdominal Adhesions

Interventions

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.

Sponsors & Collaborators

  • Unitary Enterprise UNITEHPROM BSU

    collaborator UNKNOWN

  • City Clinical Hospital of Emergency Medical Care of Minsk

    collaborator UNKNOWN

  • Research Institute for Physical Chemical Problems of the Belarusian State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-19
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Belarus

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06365632 on ClinicalTrials.gov