NCT02413658

Brief Summary

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.

Trial Health

55
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Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 10, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

1.1 years

First QC Date

March 30, 2015

Last Update Submit

April 9, 2015

Conditions

WoundRe-Epithelialization

Keywords

PhenytoinSkin graft donor siteClean surgical siteWound model

Outcome Measures

Primary Outcomes (2)

  • Percentage rate of re-epithelialization

    Pictures taken of wound site every other day will be analysed using imaging software for size of wound. Percentage rate will be calculated from this.

    Participants will be followed for the duration of hospital stay, an expected average of 20 days

  • Appearance of infection

    Pictures taken of wound site every other day will be analysed using imaging software and the Southampton wound grading scale

    Participants will be followed for the duration of hospital stay, an expected average of 20 days

Study Arms (3)

Control

ACTIVE COMPARATOR

Dressings of best current clinical practice, sugar solution.

Drug: Sugar solution

Phenytoin 1

EXPERIMENTAL

Dressings using phenytoin solution 20mg/ml

Drug: Phenytoin

Phenytoin 2

EXPERIMENTAL

Dressings using phenytoin solution 40mg/ml

Drug: Phenytoin

Interventions

PhenytoinDRUG

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

Also known as: Dilantin, Dilantin-125
Phenytoin 1Phenytoin 2
Sugar solutionDRUG
Control

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing split thickness skin graft during trial time period at Children's Surgical Centre

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Surgical Centre

Phnom Penh, Cambodia

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Phenytoin

Intervention Hierarchy (Ancestors)

HydantoinsImidazolidinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Jim Gollogly

CONTACT

+85512979214jim@csc.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 10, 2015

Study Start

March 1, 2015

Primary Completion

April 1, 2016

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

CA(1)