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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05837403

Enrollment

460

Registered

2023-05-01

Start date

2020-10-01

Completion date

2022-09-30

Last updated

2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fissure in Ano

Keywords

Fissure in Ano, Platelet-Rich Plasma, Lateral Internal Sphincterotomy

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Thirty milliliters of venous blood were withdrawn into eight syringes with preloaded 0.4 milliliters of anticoagulant (dextrose solution A) in each syringe to achieve concentration of 9:1.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

Interventions

PROCEDUREPlatelet rich plasma injection

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

DRUGNitroglycerin ointment

application of the ointment twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

• chronic anal fissure for more than three months

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Healing of fissure	3 months	Complete epithelization of fissure base

Secondary

Measure	Time frame	Description
Duration of pain	3 months	Duration of pain after passing bowel motion measured in minutes
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.

Countries

Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026