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The Use of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure

Sponsor
Al-Kindy College of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT05837403
Collaborator
(none)
460
Enrollment
1
Location
2
Arms
24
Actual Duration (Months)
19.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Platelet rich plasma injection
  • Drug: Nitroglycerin ointment
 Phase 3

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Thirty milliliters of venous blood were withdrawn into eight syringes with preloaded 0.4 milliliters of anticoagulant (dextrose solution A) in each syringe to achieve concentration of 9:1.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

Study Type:
Interventional
Actual Enrollment :
460 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Use of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure
Actual Study Start Date :
Oct 1, 2020
Actual Primary Completion Date :
Jul 30, 2022
Actual Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Nitroglycerin only

application of local Nitroglycerin ointment 2% (Recto-Relief Nitroglycerin Ointment, 30 g) applied twice daily.

Drug: Nitroglycerin ointment
application of the ointment twice daily
Other Names:
  • Rectocare - Ointment

    		•
    Experimental: platelet rich plasma injection

    injection of platelet rich plasma under fissure base and edges

    Procedure: Platelet rich plasma injection
    venous blood drown from the patient, centrifugation and separation of platelet rich plasma, injection under fissure and edges base.

    Drug: Nitroglycerin ointment
    application of the ointment twice daily
    Other Names:
  • Rectocare - Ointment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Healing of fissure [3 months]

      Complete epithelization of fissure base

    Secondary Outcome Measures

    1. Duration of pain [3 months]

      Duration of pain after passing bowel motion measured in minutes

    2. Pain change [3 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • chronic anal fissure for more than three months

    Exclusion Criteria:

    • medical comorbidity

    • inflammatory bowel disease

    • tuberculosis fissure

    • HIV infected patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Al-Kindy Teaching Hospital Baghdad Iraq 10011

    Sponsors and Collaborators

    • Al-Kindy College of Medicine

    Investigators

    • Study Chair: Taghreed Alhaidari, C.A.B.O.G, Al-Kindy College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Al-Kindy College of Medicine
    ClinicalTrials.gov Identifier:
    NCT05837403
    Other Study ID Numbers:
    • 14 Al-KindyCM
    First Posted:
    May 1, 2023
    Last Update Posted:
    May 3, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Al-Kindy College of Medicine
    Fissure in Ano
    Platelet-Rich Plasma
    Lateral Internal Sphincterotomy
    Additional relevant MeSH terms:
    Fissure in Ano
    Nitroglycerin

    Study Results

    No Results Posted as of May 3, 2023