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 | Active Not Recruiting Phase 2

• 1 other identifier: OLTOSPAN-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

phlegmonous appendicitis; ketorolac tromethamine; gel; abdominal adhesions

Outcome Measures

Primary Outcomes (1)

• Number of patients with acute phlegmonous appendicitis cured

  Number of patients cured

  from surgery to 3 weeks

Secondary Outcomes (1)

• absence of signs of adhesions

  from surgery to 4 weeks

Other Outcomes (1)

• increase in the sliding distance of the cecum

  from surgery to 7 days

Study Arms (2)

Surgical intervention due to acute phlegmanous appendicitis using the drug antispike

EXPERIMENTAL

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; Procedure: antegrade appendectomy

surgical intervention due to acute phlegmanous appendicitis

SHAM COMPARATOR

An antegrade appendectomy is performed without using Antispike.

Procedure: antegrade appendectomy

Interventions

Antispike gel, 100 g in a flask, produced by UNITEHPROM BSU, Republic of Belarus DRUG

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.

Surgical intervention due to acute phlegmanous appendicitis using the drug antispike

antegrade appendectomy PROCEDURE

An antegrade appendectomy is performed without using Antispike.

Surgical intervention due to acute phlegmanous appendicitis using the drug antispike; surgical intervention due to acute phlegmanous appendicitis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Institute for Physical Chemical Problems of the Belarusian State University: lead
• Unitary Enterprise UNITEHPROM BSU: collaborator
• City Clinical Hospital of Emergency Medical Care of Minsk: collaborator

Study Sites (1)

CITY CLINICAL EMERGENCY HOSPITAL of Minsk

Minsk, 220024, Belarus

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 15, 2024
• Study Start: March 19, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

BE (1)