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)

Research Institute for Physical Chemical Problems of the Belarusian State University

Status and phase: Active, not recruiting; Phase 2

Conditions: Abdominal Adhesions

Treatments: Drug: Antispike gel, 100 g in a flask, produced by UNITEHPROM BSU, Republic of Belarus; Procedure: antegrade appendectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06365632

OLTOSPAN-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Surgical intervention due to acute phlegmanous appendicitis using the drug antispike

Experimental group

Description:

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.

Treatment:

Procedure: antegrade appendectomy

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

surgical intervention due to acute phlegmanous appendicitis

Sham Comparator group

Description:

An antegrade appendectomy is performed without using Antispike.

Treatment:

Procedure: antegrade appendectomy