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Completed

NCT Number: NCT05837403

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

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.

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Key information

Conditions

Fissure in Ano Anus Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Al-Kindy Teaching Hospital

Baghdad, 10011, Iraq

About this study

Thirty milliliters of venous blood were withdrawn into eight syringes with preloaded 0.4 milliliters of anticoagulant (dextrose solution A) in each syringe to achieve concentration of 9:1.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • chronic anal fissure for more than three months

Exclusion criteria

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

Treatment and study plan

Platelet Rich Plasma injection

Procedure

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

Nitroglycerin Ointment

Drug

application of the ointment twice daily

Other names: Rectocare - Ointment

Primary outcomes

  1. Healing of fissure

    Time frame: 3 months

    Complete epithelization of fissure base

Secondary outcomes

  1. Duration of pain

    Time frame: 3 months

    Duration of pain after passing bowel motion measured in minutes

  2. 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.

Sponsors and collaborators

Lead sponsor

Al-Kindy College of Medicine

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 1, 2023
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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