Effect of Phenytoin Cream on Wound Healing After Anal Fissure Surgery.

NCT06633185 | Completed Phase 1

• 1 other identifier: 223345
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effect of phenytoin cream on wound healing after anal fissure surgery compared to control group.

Conditions

Anal Fissure Chronic; Anal Fissure; Wound Healing

Outcome Measures

Primary Outcomes (1)

• The duration of healing of anal fissure.

  The primary endpoint will be the duration of healing of anal fissure in days. It will be defined as complete epithelization of the anal wound.

  21 to 30 days

Secondary Outcomes (1)

• post operative complications and others

  14 to 21 days

Study Arms (2)

Topical anal phenytoin cream application

ACTIVE COMPARATOR

local application of phenytoin cream on anal wound post internal sphincterotomy for chronic anal fissure.

Drug: phenytoin cream

control arm

ACTIVE COMPARATOR

includes those with internal sphincterotomy but without application of topical phenytoin cream

Drug: no phenytoin cream

Interventions

phenytoin cream DRUG

application of the cream after internal anal sphincterotomy versus non application.

Also known as: heal quick, phenytoin

Topical anal phenytoin cream application

no phenytoin cream DRUG

Non application of the phenytoin cream

Also known as: heal quick

control arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both sexes,
• Aged between 18 and 65 years old,
• with chronic anal fissure after failure of previous conservative treatment.

You may not qualify if:

• surgically unfit patients due to multiple comorbidities,
• patients with concomitant other anorectal pathology,
• patient with anal fissure secondary to inflammatory bowel disease,
• patients with active anorectal sepsis
• patients with previous anal surgery .

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Fissure in Ano

Interventions

Phenytoin

Condition Hierarchy (Ancestors)

Anus Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 1st arm includes those patients who underwent application of topical phenytoin cream after anal fissure surgery, while the other arm includes those without application of any creams( control).

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 9, 2024
• Study Start: January 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: January 1, 2023
• Last Updated: October 9, 2024

Record last verified: 2024-09

Locations

EG (1)