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

Al-Kindy College of Medicine

Status and phase: Completed; Phase 3

Conditions: Fissure in Ano

Treatments: Drug: Nitroglycerin ointment; Procedure: Platelet rich plasma injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05837403

14 Al-KindyCM

Details and patient eligibility

About

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.

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Thirty milliliters of venous blood were withdrawn into eight syringes with preloaded 0.4 milliliters of anticoagulant (dextrose solution A) in each syringe to achieve concentration of 9:1.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

Enrollment: 460 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• chronic anal fissure for more than three months

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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460 participants in 2 patient groups

Nitroglycerin only

Active Comparator group

Description:

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

Treatment:

Drug: Nitroglycerin ointment

platelet rich plasma injection

Experimental group

Description:

injection of platelet rich plasma under fissure base and edges

Treatment:

Drug: Nitroglycerin ointment

Procedure: Platelet rich plasma injection