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

Fissure in Ano Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05837403
• Other study ID #: 14 Al-KindyCM
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: May 2023
• Source: Al-Kindy College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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Thirty milliliters of venous blood were withdrawn into eight syringes with preloaded 0.4 milliliters of anticoagulant (dextrose solution A) in each syringe to achieve concentration of 9:1.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: September 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• chronic anal fissure for more than three months

Exclusion Criteria:

• medical comorbidity

• inflammatory bowel disease

• tuberculosis fissure

• HIV infected patients

Related Conditions & MeSH terms

• Fissure in Ano

Intervention

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

Locations

Country	Name	City	State
Iraq	Al-Kindy Teaching Hospital	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
Al-Kindy College of Medicine

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing of fissure	Complete epithelization of fissure base	3 months
Secondary	Duration of pain	Duration of pain after passing bowel motion measured in minutes	3 months
Secondary	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.	3 months