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

May 1, 2023 updated by: Al-Kindy College of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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Thirty milliliters of venous blood were withdrawn into eight syringes with preloaded 0.4 milliliters of anticoagulant (dextrose solution A) in each syringe to achieve concentration of 9:1.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

Interventional

Enrollment (Actual)

460

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • Baghdad, Iraq, 10011
        • Al-Kindy Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

• chronic anal fissure for more than three months

Exclusion Criteria:

  • medical comorbidity
  • inflammatory bowel disease
  • tuberculosis fissure
  • HIV infected patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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
Drug: Nitroglycerin ointment
application of the ointment twice daily
Other Names:
  • Rectocare - Ointment
Procedure: Platelet rich plasma injection
venous blood drown from the patient, centrifugation and separation of platelet rich plasma, injection under fissure and edges base.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing of fissure
Time Frame: 3 months
Complete epithelization of fissure base
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of pain
Time Frame: 3 months
Duration of pain after passing bowel motion measured in minutes
3 months
Pain change
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Kindy College of Medicine

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

July 30, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

November 14, 2022

First Submitted That Met QC Criteria

April 27, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 1, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14 Al-KindyCM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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