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 (OLTOSPAN-02)

March 19, 2025 updated by: Research Institute for Physical Chemical Problems of the Belarusian State University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus, 220024
        • CITY CLINICAL EMERGENCY HOSPITAL of Minsk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Presence of acute phlegmonous appendicitis requiring surgical intervention.
  • Presence of medium or high risk factor for the development of adhesions of the abdominal cavity;
  • Age of patients from 18 to 65 years.
  • Absence of severe concomitant diseases in decompensation stage, oncologic diseases, as well as diseases requiring steroid therapy.
  • Presence of written informed consent of the patient to participate in the study.
  • The patient's ability to fulfill the instructions of the research physician and comply with the study design.

Exclusion Criteria:

  • At the subject own request without explaining the reasons for the behavior.
  • At the request of the physician-researcher if the subject violates the requirements of the protocol in terms of diet, smoking, consumption of alcoholic beverages, and use of medications without the prescription of the physician-researcher.
  • For reasons independent of the subject and the research physician, if the subject has drug intolerance or other life-threatening or life-threatening adverse reactions to drug administration that require emergency pharmacotherapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgical intervention due to acute phlegmanous appendicitis using the drug antispike
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. An antegrade appendectomy is performed, after which the drug Antispike is used.
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.
Sham Comparator: surgical intervention due to acute phlegmanous appendicitis
An antegrade appendectomy is performed without using Antispike.
Procedure: antegrade appendectomy
An antegrade appendectomy is performed without using Antispike.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with acute phlegmonous appendicitis cured
Time Frame: from surgery to 3 weeks
Number of patients cured
from surgery to 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
absence of signs of adhesions
Time Frame: from surgery to 4 weeks
absence of signs of adhesions according to clinical and ultrasound studies
from surgery to 4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
increase in the sliding distance of the cecum
Time Frame: from surgery to 7 days
increase in the sliding distance of the cecum, determined by the results of an ultrasound examination on the 7th day after appendectomy
from surgery to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Institute for Physical Chemical Problems of the Belarusian State University

Collaborators

Unitary Enterprise UNITEHPROM BSU
City Clinical Hospital of Emergency Medical Care of Minsk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Actual)

April 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OLTOSPAN-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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