- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02413658
Phenytoin in the Healing of Clean Surgical Wounds
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Jim Gollogly
- Phone Number: +85512979214
- Email: jim@csc.org
Study Locations
-
-
-
Phnom Penh, Cambodia
- Recruiting
- Children's Surgical Centre
-
Contact:
- Jim Gollogly
- Phone Number: +85512979124
- Email: jim@csc.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Undergoing split thickness skin graft during trial time period at Children's Surgical Centre
Exclusion Criteria:
Study Plan
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.
|
|
Experimental: Phenytoin 1
Dressings using phenytoin solution 20mg/ml
|
Topical use of phenytoin solution on dressings of split thickness skin graft sites.
Other Names:
|
Experimental: Phenytoin 2
Dressings using phenytoin solution 40mg/ml
|
Topical use of phenytoin solution on dressings of split thickness skin graft sites.
Other Names:
|
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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.
Clinical Trials on Wound
-
Brigham and Women's HospitalCompletedSurgical Wound | Wound Heal | Wound of Skin | Wound OpenUnited States
-
ConvaTec Inc.Not yet recruitingSurgical Wound, Recent | Trauma-related Wound | Dehiscence Wound | Surgical Wound LeakUnited States
-
Massachusetts General HospitalCompletedWound Healing | Traumatic Wound | Infective Wound | Iatrogenic Critical Sized Wound DefectsUnited States
-
Pulmatrix Inc.TerminatedPost Operative Wound Infection | Postoperative Wound Infection-deepUnited States
-
University of Roma La SapienzaCompletedWound Heal | Wound Surgical | Oral Soft Tissue ConditionsItaly
-
khalid abd aziz mohamedArmed Forces Hospitals, Southern Region, Saudi ArabiaUnknownDecreasing Wound InfectionSaudi Arabia
-
St. Borbala HospitalSemmelweis University; Department of Surgery, Jahn Ferend Dél-Pesti Kórház... and other collaboratorsTerminatedSurgical Wound | Surgical Site Infection | Wound Dehiscence, Surgical | Dehiscence of Internal Surgical WoundHungary
-
Universidade Estadual Paulista Júlio de Mesquita...RecruitingWound Healing | Palate; WoundBrazil
-
Central Finland Hospital DistrictUniversity of Eastern Finland; Tampere University HospitalActive, not recruitingWound Heal | Wound | Skin Wound | Skin Scarring | Wound of Skin | Wound Open | Wound BreakdownFinland
-
Mansoura UniversityUnknownWound Infection | Wound SurgicalEgypt
Clinical Trials on Sugar solution
-
University of Maryland, BaltimoreCompletedPrematurity | Intestinal PermeabilityUnited States
-
NYU Langone HealthNaurex, Inc, an affiliate of Allergan plcWithdrawn
-
IRCCS Burlo GarofoloRecruiting
-
The Cleveland ClinicCompleted
-
Lady Hardinge Medical CollegeCompleted
-
Weill Medical College of Cornell UniversityWithdrawn
-
Wageningen UniversityCompleted
-
Ningbo Municipal No.4 HospitalUnknownWound Infection | Sugar Solution
-
Wageningen UniversityCompleted
-
Mead Johnson NutritionCompletedGastroenteritis AcuteThailand