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

Abdominal Adhesions Clinical Trial

— OLTOSPAN-02  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06365632
• Other study ID #: OLTOSPAN-02
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Research Institute for Physical Chemical Problems of the Belarusian State University
• Contact: Eugen Grinyuk, Ph.D., Associate professor
• Phone: +375 17 209-52-54
• Email: hryniuk[@]bsu.by
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Adhesions
• Appendicitis
• Tissue Adhesions

Intervention

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.

Locations

Country	Name	City	State
Belarus	CITY CLINICAL EMERGENCY HOSPITAL of Minsk	Minsk
Belarus	CITY CLINICAL EMERGENCY HOSPITAL of Minsk	Minsk

Sponsors (3)

Lead Sponsor	Collaborator
Research Institute for Physical Chemical Problems of the Belarusian State University	City Clinical Hospital of Emergency Medical Care of Minsk, Unitary Enterprise UNITEHPROM BSU

Country where clinical trial is conducted

Belarus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	increase in the sliding distance of the cecum	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
Primary	Number of patients with acute phlegmonous appendicitis cured	Number of patients cured	from surgery to 3 weeks
Secondary	absence of signs of adhesions	absence of signs of adhesions according to clinical and ultrasound studies	from surgery to 4 weeks