The Use of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure
Primary Purpose
Fissure in Ano
Status
Completed
Phase
Phase 3
Locations
Iraq
Study Type
Interventional
Intervention
Platelet rich plasma injection
Nitroglycerin ointment
Sponsored by
About this trial
This is an interventional treatment trial for Fissure in Ano focused on measuring Fissure in Ano, Platelet-Rich Plasma, Lateral Internal Sphincterotomy
Eligibility Criteria
Inclusion Criteria: • chronic anal fissure for more than three months Exclusion Criteria: medical comorbidity inflammatory bowel disease tuberculosis fissure HIV infected patients
Sites / Locations
- Al-Kindy Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Nitroglycerin only
platelet rich plasma injection
Arm Description
application of local Nitroglycerin ointment 2% (Recto-Relief Nitroglycerin Ointment, 30 g) applied twice daily.
injection of platelet rich plasma under fissure base and edges
Outcomes
Primary Outcome Measures
Healing of fissure
Complete epithelization of fissure base
Secondary Outcome Measures
Duration of pain
Duration of pain after passing bowel motion measured in minutes
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.
Full Information
NCT ID
NCT05837403
First Posted
November 14, 2022
Last Updated
May 1, 2023
Sponsor
Al-Kindy College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05837403
Brief Title
The Use of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure
Official Title
The Use of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Al-Kindy College of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fissure in Ano
Keywords
Fissure in Ano, Platelet-Rich Plasma, Lateral Internal Sphincterotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
460 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nitroglycerin only
Arm Type
Active Comparator
Arm Description
application of local Nitroglycerin ointment 2% (Recto-Relief Nitroglycerin Ointment, 30 g) applied twice daily.
Arm Title
platelet rich plasma injection
Arm Type
Experimental
Arm Description
injection of platelet rich plasma under fissure base and edges
Intervention Type
Procedure
Intervention Name(s)
Platelet rich plasma injection
Intervention Description
venous blood drown from the patient, centrifugation and separation of platelet rich plasma, injection under fissure and edges base.
Intervention Type
Drug
Intervention Name(s)
Nitroglycerin ointment
Other Intervention Name(s)
Rectocare - Ointment
Intervention Description
application of the ointment twice daily
Primary Outcome Measure Information:
Title
Healing of fissure
Description
Complete epithelization of fissure base
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Duration of pain
Description
Duration of pain after passing bowel motion measured in minutes
Time Frame
3 months
Title
Pain change
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• chronic anal fissure for more than three months
Exclusion Criteria:
medical comorbidity
inflammatory bowel disease
tuberculosis fissure
HIV infected patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taghreed Alhaidari, C.A.B.O.G
Organizational Affiliation
Al-Kindy College of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Al-Kindy Teaching Hospital
City
Baghdad
ZIP/Postal Code
10011
Country
Iraq
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Use of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure
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