Phenytoin in the Healing of Clean Surgical Wounds

NCT ID: NCT02413658

Last Updated: 2015-04-10

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Brief Summary

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The purpose of this study is to investigate the potential healing properties of phenytoin.

The investigators will use the donor site of a split skin thickness graft (SSTG) to model a basic wound in a randomized controlled trial of topical phenytoin against current best clinical practice. The investigators aim to demonstrate a dose dependent effect. The investigators hypothesis, based on previous clinical experience at our center and on current available literature, that phenytoin will reduce wound healing time.

Detailed Description

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Conditions

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Wound Re-Epithelialization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Control

Dressings of best current clinical practice, sugar solution.

Group Type ACTIVE_COMPARATOR

Sugar solution

Intervention Type DRUG

Phenytoin 1

Dressings using phenytoin solution 20mg/ml

Group Type EXPERIMENTAL

Phenytoin

Intervention Type DRUG

Topical use of phenytoin solution on dressings of split thickness skin graft sites.

Phenytoin 2

Dressings using phenytoin solution 40mg/ml

Group Type EXPERIMENTAL

Phenytoin

Intervention Type DRUG

Topical use of phenytoin solution on dressings of split thickness skin graft sites.

Interventions

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Phenytoin

Topical use of phenytoin solution on dressings of split thickness skin graft sites.

Intervention Type DRUG

Sugar solution

Intervention Type DRUG

Other Intervention Names

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Dilantin, Dilantin-125

Eligibility Criteria

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Inclusion Criteria

* Undergoing split thickness skin graft during trial time period at Children's Surgical Centre
Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Surgical Center, Cambodia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Children's Surgical Centre

Phnom Penh, , Cambodia

Site Status RECRUITING

Countries

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Cambodia

Central Contacts

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Jim Gollogly

Role: CONTACT

+85512979214

Facility Contacts

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Jim Gollogly

Role: primary

+85512979124

Other Identifiers

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1CSC2015

Identifier Type: -

Identifier Source: org_study_id

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