Abdominal AdhesionsPhase 2OLTOSPAN-02NCT06365632
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
A Phase 2 study testing Antispike gel, 100 g in a flask, produced by UNITEHPROM BSU, Republic of Belarus and antegrade appendectomy in people with Abdominal Adhesions, run by Research Institute for Physical Chemical Problems of the Belarusian State University at 1 site in Belarus.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Abdominal Adhesions
- What is being tested?
- Antispike gel, 100 g in a flask, produced by UNITEHPROM BSU, Republic of Belarus and antegrade appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBelarus
- Study dates
- 19 Mar 2025to Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Abdominal Adhesions
- Being tested
- Antispike gel, 100 g in a flask, produced by UNITEHPROM BSU, Republic of Belarus, antegrade appendectomy
- Keywords
- phlegmonous appendicitis, ketorolac tromethamine, gel, abdominal adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antispike gel, 100 g in a flask, produced by UNITEHPROM BSU, Republic of BelarusDrug
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 appendectomyProcedure or surgery
An antegrade appendectomy is performed without using Antispike.
| Study group | Role | What they receive |
|---|---|---|
| Surgical intervention due to acute phlegmanous appendicitis using the drug antispike | Experimental | 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. Receives: Drug: Antispike gel, 100 g in a flask, produced by UNITEHPROM BSU, Republic of Belarus; Procedure: antegrade appendectomy |
| surgical intervention due to acute phlegmanous appendicitis | Sham comparator | An antegrade appendectomy is performed without using Antispike. Receives: Procedure: antegrade appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with acute phlegmonous appendicitis cured
Number of patients cured
Measured: from surgery to 3 weeks
Secondary outcomes (1)
absence of signs of adhesions
absence of signs of adhesions according to clinical and ultrasound studies
Measured: from surgery to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start19 Mar 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal AdhesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Institute for Physical Chemical Problems of the Belarusian State University
- Sponsor type
- University, hospital or other
- Collaborators
- Unitary Enterprise UNITEHPROM BSU, City Clinical Hospital of Emergency Medical Care of Minsk
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365632
- Sponsor's protocol ID
- OLTOSPAN-02
- Acronym
- OLTOSPAN-02
- Status last verified
- Mar 2025
- First submitted
- 9 Apr 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06365632
- Acronym / sponsor ID
- OLTOSPAN-02 / OLTOSPAN-02
- Conditions
- Abdominal Adhesions
- Keywords
- phlegmonous appendicitis, ketorolac tromethamine, gel, abdominal adhesions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Research Institute for Physical Chemical Problems of the Belarusian State UniversityUniversity, hospital or other
- Collaborators
- Unitary Enterprise UNITEHPROM BSU, City Clinical Hospital of Emergency Medical Care of Minsk
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical intervention due to acute phlegmanous appendicitis using the drug antispike | Experimental | Drug: Antispike gel, 100 g in a flask, produced by UNITEHPROM BSU, Republic of Belarus, Procedure: antegrade appendectomyPlacebo-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. |
| surgical intervention due to acute phlegmanous appendicitis | Sham comparator | Procedure: antegrade appendectomyAn antegrade appendectomy is performed without using Antispike. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antispike gel, 100 g in a flask, produced by UNITEHPROM BSU, Republic of BelarusAn 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. | Drug | Surgical intervention due to acute phlegmanous appendicitis using the drug antispike |
| antegrade appendectomyAn antegrade appendectomy is performed without using Antispike. | Procedure or surgery | Surgical intervention due to acute phlegmanous appendicitis using the drug antispike, surgical intervention due to acute phlegmanous appendicitis |
Primary outcome
Number of patients with acute phlegmonous appendicitis cured
Time frame: from surgery to 3 weeks
Number of patients cured
1 secondary outcome
absence of signs of adhesions
Time frame: from surgery to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antispike gel, 100 g in a flask, produced by UNITEHPROM BSU, Republic of Belarus and antegrade appendectomy in people with Abdominal Adhesions, run by Research Institute for Physical Chemical Problems of the Belarusian State University at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with acute phlegmonous appendicitis cured (time frame: from surgery to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.