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Phenytoin in the Healing of Clean Surgical Wounds

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ClinicalTrials.gov Identifier: NCT02413658
Recruitment Status : Unknown
Verified April 2015 by Children's Surgical Center, Cambodia.
Recruitment status was:  Recruiting
First Posted : April 10, 2015
Last Update Posted : April 10, 2015
Sponsor:
Information provided by (Responsible Party):
Children's Surgical Center, Cambodia

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
Wound Re-Epithelialization Drug: Phenytoin Drug: Sugar solution Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2015
Estimated Primary Completion Date : April 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Dilantin, Dilantin-125




Primary Outcome Measures :
  1. 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.

  2. 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



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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02413658


Contacts
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Contact: Jim Gollogly +85512979214 jim@csc.org

Locations
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Cambodia
Children's Surgical Centre Recruiting
Phnom Penh, Cambodia
Contact: Jim Gollogly    +85512979124    jim@csc.org   
Sponsors and Collaborators
Children's Surgical Center, Cambodia

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Responsible Party: Children's Surgical Center, Cambodia
ClinicalTrials.gov Identifier: NCT02413658     History of Changes
Other Study ID Numbers: 1CSC2015
First Posted: April 10, 2015    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015

Keywords provided by Children's Surgical Center, Cambodia:
Phenytoin
Skin graft donor site
Clean surgical site
Wound model

Additional relevant MeSH terms:
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Phenytoin
Wounds and Injuries
Surgical Wound
Pharmaceutical Solutions
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers