Clinical Study of the Effectiveness, Tolerability and Safety of the Drug "Anti-spike, Gel, 100 g … (NCT06365632) | Clinical Trial Compass
Active — Not RecruitingPhase 2
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
Belarus100 participantsStarted 2025-03-19
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Number of patients with acute phlegmonous appendicitis cured
Timeframe: from surgery to 3 weeks
Trial details
NCT IDNCT06365632
SponsorResearch Institute for Physical Chemical Problems of the Belarusian State University