WoundPhase 2NCT02413658
Phenytoin in the Healing of Clean Surgical Wounds
A Phase 2 study testing Phenytoin and Sugar solution in people with Wound and Re-Epithelialization, run by Children's Surgical Center, Cambodia at 1 site in Cambodia.
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. Read more about this study
- Who is it for?
- Ages Up to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound, Re-Epithelialization
- What is being tested?
- Phenytoin and Sugar solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCambodia
- Study dates
- Mar 2015to Apr 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Undergoing split thickness skin graft during trial time period at Children's Surgical Centre
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Cambodia1 site, 1 recruiting
- Recruiting
Children's Surgical Centre
Phnom Penh
Jim Gollogly, +85512979124, jim@csc.org
About this study
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.
- Conditions
- Wound, Re-Epithelialization
- Being tested
- Phenytoin, Sugar solution
- Keywords
- Phenytoin, Skin graft donor site, Clean surgical site, Wound model
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenytoinDrug
Also called Dilantin, Dilantin-125
Topical use of phenytoin solution on dressings of split thickness skin graft sites.
Sugar solutionDrug
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Dressings of best current clinical practice, sugar solution. Receives: Drug: Sugar solution |
| Phenytoin 1 | Experimental | Dressings using phenytoin solution 20mg/ml Receives: Drug: Phenytoin |
| Phenytoin 2 | Experimental | Dressings using phenytoin solution 40mg/ml Receives: Drug: Phenytoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 20 days
Appearance of infection
Pictures taken of wound site every other day will be analysed using imaging software and the Southampton wound grading scale
Measured: Participants will be followed for the duration of hospital stay, an expected average of 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Surgical Center, Cambodia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413658
- Sponsor's protocol ID
- 1CSC2015
- Status last verified
- Apr 2015
- First submitted
- 30 Mar 2015
- Last updated
- 10 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenytoin in the Healing of Clean Surgical Wounds
- ClinicalTrials.gov ID
- NCT02413658
- Acronym / sponsor ID
- 1CSC2015
- Conditions
- Wound, Re-Epithelialization
- Keywords
- Phenytoin, Skin graft donor site, Clean surgical site, Wound model
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Children's Surgical Center, CambodiaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Apr 2016 (estimated)
- First posted
- 10 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Sugar solutionDressings of best current clinical practice, sugar solution. |
| Phenytoin 1 | Experimental | Drug: PhenytoinDressings using phenytoin solution 20mg/ml |
| Phenytoin 2 | Experimental | Drug: PhenytoinDressings using phenytoin solution 40mg/ml |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing split thickness skin graft during trial time period at Children's Surgical Centre
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhenytoinAlso: Dilantin, Dilantin-125Topical use of phenytoin solution on dressings of split thickness skin graft sites. | Drug | Phenytoin 1, Phenytoin 2 |
| Sugar solution | Drug | Control |
Primary outcome
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Phenytoin and Sugar solution in people with Wound and Re-Epithelialization, run by Children's Surgical Center, Cambodia at 1 site in Cambodia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jim Gollogly (+85512979214, jim@csc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage rate of re-epithelialization (time frame: Participants will be followed for the duration of hospital stay, an expected average of 20 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2015.