NCT05837403

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

1.8 years

First QC Date

November 14, 2022

Last Update Submit

May 1, 2023

Conditions

Fissure in Ano

Keywords

Fissure in AnoPlatelet-Rich PlasmaLateral Internal Sphincterotomy

Outcome Measures

Primary Outcomes (1)

  • Healing of fissure

    Complete epithelization of fissure base

    3 months

Secondary Outcomes (2)

  • Duration of pain

    3 months

  • Pain change

    3 months

Study Arms (2)

Nitroglycerin only

ACTIVE COMPARATOR

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

Drug: Nitroglycerin ointment

platelet rich plasma injection

EXPERIMENTAL

injection of platelet rich plasma under fissure base and edges

Procedure: Platelet rich plasma injectionDrug: Nitroglycerin ointment

Interventions

Platelet rich plasma injectionPROCEDURE

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

platelet rich plasma injection
Nitroglycerin ointmentDRUG

application of the ointment twice daily

Also known as: Rectocare - Ointment
Nitroglycerin onlyplatelet rich plasma injection

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • chronic anal fissure for more than three months

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Kindy Teaching Hospital

Baghdad, 10011, Iraq

Location

MeSH Terms

Conditions

Fissure in Ano

Condition Hierarchy (Ancestors)

Anus DiseasesRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Taghreed Alhaidari, C.A.B.O.G

    Al-Kindy College of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2022

First Posted

May 1, 2023

Study Start

October 1, 2020

Primary Completion

July 30, 2022

Study Completion

September 30, 2022

Last Updated

May 3, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)