Phenytoin in the Healing of Clean Surgical Wounds

April 9, 2015 updated by: Children's Surgical Center, Cambodia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cambodia
      • Phnom Penh, Cambodia
        • Recruiting
        • Children's Surgical Centre
        • Contact:
          • Jim Gollogly
          • Phone Number: +85512979124
          • Email: jim@csc.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Dressings of best current clinical practice, sugar solution.
Drug: Sugar solution
Experimental: Phenytoin 1
Dressings using phenytoin solution 20mg/ml
Drug: Phenytoin
Topical use of phenytoin solution on dressings of split thickness skin graft sites.
Other Names:
  • Dilantin, Dilantin-125
Experimental: Phenytoin 2
Dressings using phenytoin solution 40mg/ml
Drug: Phenytoin
Topical use of phenytoin solution on dressings of split thickness skin graft sites.
Other Names:
  • Dilantin, Dilantin-125

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage rate of re-epithelialization
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 20 days
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
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 20 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Surgical Center, Cambodia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

March 30, 2015

First Submitted That Met QC Criteria

April 9, 2015

First Posted (Estimate)

April 10, 2015

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1CSC2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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