Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365632
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-09
Brief Title:
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
Sponsor:
Research Institute for Physical Chemical Problems of the Belarusian State University
Organization:
Research Institute for Physical Chemical Problems of the Belarusian State University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OLTOSPAN-02
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None