Fissure in AnoPhase 3NCT05837403
The Use of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure
A Phase 3 study testing Platelet rich plasma injection and Nitroglycerin ointment in people with Fissure in Ano, run by Al-Kindy College of Medicine at 1 site in Iraq.
Trial summary
use of platelet rich plasma had good effect in treating chronic wounds. healing of perianal fissure could be prolonged and associated with pain. injection of platelet rich plasma under fissure base and edges had the advantage of improved fissure healing and reduction of the pain, with minimal side effects. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Fissure in Ano
- What is being tested?
- Platelet rich plasma injection and Nitroglycerin ointment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteIraq
- Study dates
- 1 Oct 2020to 30 Sep 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- chronic anal fissure for more than three months
Who cannot join
- medical comorbidity
- inflammatory bowel disease
- tuberculosis fissure
- HIV infected patients
Trial locations and contacts
1 site in 1 country.
About this study
use of platelet rich plasma had good effect in treating chronic wounds. healing of perianal fissure could be prolonged and associated with pain. injection of platelet rich plasma under fissure base and edges had the advantage of improved fissure healing and reduction of the pain, with minimal side effects.
Read the detailed description
Thirty milliliters of venous blood were withdrawn into eight syringes with preloaded 0.4 milliliters of anticoagulant (dextrose solution A) in each syringe to achieve concentration of 9:1.
The mixture centrifuged for 3000 round per minute for three minutes. After centrifugation separation of supernatant from the red blood cells, using three way-stopcock connector to collect the supernatant of all syringes into four new syringes that preloaded with 1 microgram of Prostaglandin E1 that diluted in normal saline (0.05 milliliters).
The four syringes centrifuge at 4000 round per minute for 15 minutes. The supernatant discarded using a three way-stopcock connector. The sediment mixed with vortex mixer (Vortex V-1 plus, BIOSAN).
- Conditions
- Fissure in Ano
- Being tested
- Platelet rich plasma injection, Nitroglycerin ointment
- Keywords
- Fissure in Ano, Platelet-Rich Plasma, Lateral Internal Sphincterotomy
- Medical subject headings
- Fissure in Ano
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasma injectionProcedure or surgery
venous blood drown from the patient, centrifugation and separation of platelet rich plasma, injection under fissure and edges base.
Nitroglycerin ointmentDrug
Also called Rectocare - Ointment
application of the ointment twice daily
| Study group | Role | What they receive |
|---|---|---|
| Nitroglycerin only | Active comparator | application of local Nitroglycerin ointment 2% (Recto-Relief Nitroglycerin Ointment, 30 g) applied twice daily. Receives: Drug: Nitroglycerin ointment |
| platelet rich plasma injection | Experimental | injection of platelet rich plasma under fissure base and edges Receives: Procedure: Platelet rich plasma injection; Drug: Nitroglycerin ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of fissure
Complete epithelization of fissure base
Measured: 3 months
Secondary outcomes (2)
Duration of pain
Duration of pain after passing bowel motion measured in minutes
Measured: 3 months
Pain change
Visual analog scale for measuring the intensity of pain (the higher score means the more severe the pain) explained as 0 represent no pain at all, and 10 represent the severest pain ever felt.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Oct 2020
- Primary completion30 Jul 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fissure in AnoStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Kindy College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taghreed Alhaidari, C.A.B.O.G, Study chair, Al-Kindy College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837403
- Sponsor's protocol ID
- 14 Al-KindyCM
- Status last verified
- May 2023
- First submitted
- 14 Nov 2022
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure
- ClinicalTrials.gov ID
- NCT05837403
- Acronym / sponsor ID
- 14 Al-KindyCM
- Conditions
- Fissure in Ano
- Keywords
- Fissure in Ano, Platelet-Rich Plasma, Lateral Internal Sphincterotomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Al-Kindy College of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 1 May 2023 (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.
use of platelet rich plasma had good effect in treating chronic wounds. healing of perianal fissure could be prolonged and associated with pain. injection of platelet rich plasma under fissure base and edges had the advantage of improved fissure healing and reduction of the pain, with minimal side effects.
Detailed description
Thirty milliliters of venous blood were withdrawn into eight syringes with preloaded 0.4 milliliters of anticoagulant (dextrose solution A) in each syringe to achieve concentration of 9:1.
The mixture centrifuged for 3000 round per minute for three minutes. After centrifugation separation of supernatant from the red blood cells, using three way-stopcock connector to collect the supernatant of all syringes into four new syringes that preloaded with 1 microgram of Prostaglandin E1 that diluted in normal saline (0.05 milliliters).
The four syringes centrifuge at 4000 round per minute for 15 minutes. The supernatant discarded using a three way-stopcock connector. The sediment mixed with vortex mixer (Vortex V-1 plus, BIOSAN).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitroglycerin only | Active comparator | Drug: Nitroglycerin ointmentapplication of local Nitroglycerin ointment 2% (Recto-Relief Nitroglycerin Ointment, 30 g) applied twice daily. |
| platelet rich plasma injection | Experimental | Procedure: Platelet rich plasma injection, Drug: Nitroglycerin ointmentinjection of platelet rich plasma under fissure base and edges |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- chronic anal fissure for more than three months
Key exclusion criteria (4 listed)
- medical comorbidity
- inflammatory bowel disease
- tuberculosis fissure
- HIV infected patients
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 |
|---|---|---|
| Platelet rich plasma injectionvenous blood drown from the patient, centrifugation and separation of platelet rich plasma, injection under fissure and edges base. | Procedure or surgery | platelet rich plasma injection |
| Nitroglycerin ointmentAlso: Rectocare - Ointmentapplication of the ointment twice daily | Drug | Nitroglycerin only, platelet rich plasma injection |
Primary outcome
Healing of fissure
Time frame: 3 months
Complete epithelization of fissure base
2 secondary outcomes
Duration of pain
Time frame: 3 months
Pain change
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: No
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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.
Taghreed Alhaidari, C.A.B.O.G study chair
Al-Kindy College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Platelet rich plasma injection and Nitroglycerin ointment in people with Fissure in Ano, run by Al-Kindy College of Medicine at 1 site in Iraq.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 3 May 2023. 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 Iraq. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Healing of fissure (time frame: 3 months). 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 3 May 2023.