Phenytoin in the Healing of Clean Surgical Wounds

Children's Surgical Center, Cambodia

Status and phase: Unknown; Phase 2

Conditions: Wound; Re-Epithelialization

Treatments: Drug: Phenytoin; Drug: Sugar solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02413658

1CSC2015

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: Under 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 3 patient groups

Control

Active Comparator group

Description:

Dressings of best current clinical practice, sugar solution.

Treatment:

Drug: Sugar solution

Phenytoin 1

Experimental group

Description:

Dressings using phenytoin solution 20mg/ml

Treatment:

Drug: Phenytoin

Phenytoin 2

Experimental group

Description:

Dressings using phenytoin solution 40mg/ml

Treatment:

Drug: Phenytoin