Phenytoin in the Healing of Clean Surgical Wounds

Wound Clinical Trial

Official title:

Phenytoin in the Healing of Clean Surgical Wounds

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02413658
• Other study ID #: 1CSC2015
• Status: Recruiting
• Phase: Phase 2
• First received: March 30, 2015
• Last updated: April 9, 2015
• Start date: March 2015

Study information

• Verified date: April 2015
• Source: Children's Surgical Center, Cambodia
• Contact: Jim Gollogly
• Phone: +85512979214
• Email: jim[@]csc.org
• Is FDA regulated: No
• Health authority: Cambodia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Re-Epithelialization
• Wound

Intervention

Drug:
• Phenytoin
Topical use of phenytoin solution on dressings of split thickness skin graft sites.
• Sugar solution

Locations

Country	Name	City	State
Cambodia	Children's Surgical Centre	Phnom Penh

Sponsors (1)

Lead Sponsor	Collaborator
Children's Surgical Center, Cambodia

Country where clinical trial is conducted

Cambodia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Participants will be followed for the duration of hospital stay, an expected average of 20 days	No
Primary	Appearance of infection	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	No