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Phenytoin in the Healing of Clean Surgical Wounds

Sponsor
Children's Surgical Center, Cambodia (Other)
Overall Status
Unknown status
CT.gov ID
NCT02413658
Collaborator
(none)
100
Enrollment
1
Location
3
Arms

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Phenytoin in the Healing of Clean Surgical Wounds
Study Start Date :
Mar 1, 2015
Anticipated Primary Completion Date :
Apr 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage rate of re-epithelialization [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.

    2. Appearance of infection [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Undergoing split thickness skin graft during trial time period at Children's Surgical Centre
    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Surgical Centre Phnom Penh Cambodia

    Sponsors and Collaborators

    • Children's Surgical Center, Cambodia

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Surgical Center, Cambodia
    ClinicalTrials.gov Identifier:
    NCT02413658
    Other Study ID Numbers:
    • 1CSC2015
    First Posted:
    Apr 10, 2015
    Last Update Posted:
    Apr 10, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by Children's Surgical Center, Cambodia
    Phenytoin
    Skin graft donor site
    Clean surgical site
    Wound model
    Additional relevant MeSH terms:
    Wounds and Injuries
    Surgical Wound
    Phenytoin

    Study Results

    No Results Posted as of Apr 10, 2015