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

Phase 3

Completed

• Conditions: Fissure in Ano
• Interventions: Drug: Nitroglycerin ointment; Procedure: Platelet rich plasma injection

• Registration Number: NCT05837403
• Lead Sponsor: Al-Kindy College of Medicine

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Thirty milliliters of venous blood were withdrawn into eight syringes with preloaded 0.4 milliliters of anticoagulant (dextrose solution A) in each syringe to achieve concentration of 9:1.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

Study Timeline

• Study Start: 2020-10-01
• Primary Completion: 2022-07-30
• Study Completion: 2022-09-30
• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2023-04-27
• Status Verified: 2023-05
• Study First Posted: 2023-05-01
• Last Update Submitted: 2023-05-01
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

• chronic anal fissure for more than three months

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nitroglycerin only	Nitroglycerin ointment	application of local Nitroglycerin ointment 2% (Recto-Relief Nitroglycerin Ointment, 30 g) applied twice daily.
platelet rich plasma injection	Platelet rich plasma injection	injection of platelet rich plasma under fissure base and edges
platelet rich plasma injection	Nitroglycerin ointment	injection of platelet rich plasma under fissure base and edges

Primary Outcome Measures

Name	Time	Method
Healing of fissure	3 months	Complete epithelization of fissure base

Secondary Outcome Measures

Name	Time	Method
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.
Duration of pain	3 months	Duration of pain after passing bowel motion measured in minutes

Trial Locations

Locations (1)

Al-Kindy Teaching Hospital; 🇮🇶 Baghdad, Iraq