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

NCT ID: NCT05837403

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-09-30

Brief Summary

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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

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Thirty milliliters of venous blood were withdrawn into eight syringes with preloaded 0.4 milliliters of anticoagulant (dextrose solution A) in each syringe to achieve concentration of 9:1.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

Conditions

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Fissure in Ano

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Nitroglycerin only

application of local Nitroglycerin ointment 2% (Recto-Relief Nitroglycerin Ointment, 30 g) applied twice daily.

Group Type ACTIVE_COMPARATOR

Nitroglycerin ointment

Intervention Type DRUG

application of the ointment twice daily

platelet rich plasma injection

injection of platelet rich plasma under fissure base and edges

Group Type EXPERIMENTAL

Platelet rich plasma injection

Intervention Type PROCEDURE

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

Nitroglycerin ointment

Intervention Type DRUG

application of the ointment twice daily

Interventions

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Platelet rich plasma injection

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

Intervention Type PROCEDURE

Nitroglycerin ointment

application of the ointment twice daily

Intervention Type DRUG

Other Intervention Names

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Rectocare - Ointment

Eligibility Criteria

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Inclusion Criteria

• chronic anal fissure for more than three months

Exclusion Criteria

* medical comorbidity
* inflammatory bowel disease
* tuberculosis fissure
* HIV infected patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Kindy College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Taghreed Alhaidari, C.A.B.O.G

Role: STUDY_CHAIR

Al-Kindy College of Medicine

Locations

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Al-Kindy Teaching Hospital

Baghdad, , Iraq

Site Status

Countries

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Iraq

Other Identifiers

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14 Al-KindyCM

Identifier Type: -

Identifier Source: org_study_id

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