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
NCT ID: NCT06365632
Last Updated: 2025-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2025-03-19
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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.
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.
antegrade appendectomy
An antegrade appendectomy is performed without using Antispike.
surgical intervention due to acute phlegmanous appendicitis
An antegrade appendectomy is performed without using Antispike.
antegrade appendectomy
An antegrade appendectomy is performed without using Antispike.
Interventions
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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.
antegrade appendectomy
An antegrade appendectomy is performed without using Antispike.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Unitary Enterprise UNITEHPROM BSU
UNKNOWN
City Clinical Hospital of Emergency Medical Care of Minsk
UNKNOWN
Research Institute for Physical Chemical Problems of the Belarusian State University
OTHER
Responsible Party
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Locations
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CITY CLINICAL EMERGENCY HOSPITAL of Minsk
Minsk, , Belarus
Countries
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Other Identifiers
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OLTOSPAN-02
Identifier Type: -
Identifier Source: org_study_id
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