Back to resultsPhenytoin in the Healing of Clean Surgical Wounds
Primary Purpose
Wound, Re-Epithelialization
Status
Unknown status
Phase
Phase 2
Locations
Cambodia
Study Type
Interventional
Intervention
Phenytoin
Sugar solution
Sponsored by
About this trial
This is an interventional treatment trial for Wound focused on measuring Phenytoin, Skin graft donor site, Clean surgical site, Wound model
Eligibility Criteria
Inclusion Criteria:
- Undergoing split thickness skin graft during trial time period at Children's Surgical Centre
Exclusion Criteria:
Sites / Locations
- Children's Surgical CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control
Phenytoin 1
Phenytoin 2
Arm Description
Dressings of best current clinical practice, sugar solution.
Dressings using phenytoin solution 20mg/ml
Dressings using phenytoin solution 40mg/ml
Outcomes
Primary Outcome Measures
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.
Appearance of infection
Pictures taken of wound site every other day will be analysed using imaging software and the Southampton wound grading scale
Secondary Outcome Measures
Full Information
NCT ID
NCT02413658
First Posted
March 30, 2015
Last Updated
April 9, 2015
Sponsor
Children's Surgical Center, Cambodia
1. Study Identification
Unique Protocol Identification Number
NCT02413658
Brief Title
Phenytoin in the Healing of Clean Surgical Wounds
Official Title
Phenytoin in the Healing of Clean Surgical Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Surgical Center, Cambodia
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound, Re-Epithelialization
Keywords
Phenytoin, Skin graft donor site, Clean surgical site, Wound model
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Dressings of best current clinical practice, sugar solution.
Arm Title
Phenytoin 1
Arm Type
Experimental
Arm Description
Dressings using phenytoin solution 20mg/ml
Arm Title
Phenytoin 2
Arm Type
Experimental
Arm Description
Dressings using phenytoin solution 40mg/ml
Intervention Type
Drug
Intervention Name(s)
Phenytoin
Other Intervention Name(s)
Dilantin, Dilantin-125
Intervention Description
Topical use of phenytoin solution on dressings of split thickness skin graft sites.
Intervention Type
Drug
Intervention Name(s)
Sugar solution
Primary Outcome Measure Information:
Title
Percentage rate of re-epithelialization
Description
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.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 20 days
Title
Appearance of infection
Description
Pictures taken of wound site every other day will be analysed using imaging software and the Southampton wound grading scale
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 20 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Undergoing split thickness skin graft during trial time period at Children's Surgical Centre
Exclusion Criteria:
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jim Gollogly
Phone
+85512979214
Email
jim@csc.org
Facility Information:
Facility Name
Children's Surgical Centre
City
Phnom Penh
Country
Cambodia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jim Gollogly
Phone
+85512979124
Email
jim@csc.org
12. IPD Sharing Statement
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Phenytoin in the Healing of Clean Surgical Wounds
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