Surgical ScarsNCT01201525
Pulsed Dye Laser Treatment of Recent Surgical Scars
A study testing Pulsed dye laser treatment in people with Surgical Scars, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Hypothesis: Improvement of recent surgical scars after treatment with 595nm Pulsed dye laser treatments. Study design: Prospective single blinded within patient controlled randomised trial. Recent surgical scars of at least 5cm will be divided into 2 parts and randomized. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Scars
- What is being tested?
- Pulsed dye laser treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2009to Aug 2011
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with planned surgical intervention leaving a scar from at least 5 cm in an area prone to hypertrophic scarring : neck, shoulders, chest, mandibular angle and extremities
- Age at least 18 years old.
- Patient able and willing to give written informed consent
Who cannot join
- Patients with planned surgical intervention on hands, feet and genital area
- Patients with a history of photodermatoses
- Patients with a history of keloids
- Patients with a history of adverse outcomes related to PDL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulsed Dye Laser Treatment of Recent Surgical Scars: A Prospective Single Blinded Within Patient Controlled Randomized Trial
Hypothesis: Improvement of recent surgical scars after treatment with 595nm Pulsed dye laser treatments.
Study design: Prospective single blinded within patient controlled randomised trial. Recent surgical scars of at least 5cm will be divided into 2 parts and randomized. 1 part will be treated with 4 595nm Pulsed dye laser treatments on a 4 weeks interval. The other part will serve as a within patient control. 1 and 6 months after the intervention both parts of the scar will be evaluated.
- Conditions
- Surgical Scars
- Being tested
- Pulsed dye laser treatment, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed dye laser treatmentProcedure or surgery
Part 1 of the surgical scar will be treated with 4 595nm Pulsed dye laser treatments.
ControlProcedure or surgery
Part 2 of the surgical scar will serve as a within patient control.
| Study group | Role | What they receive |
|---|---|---|
| Surgical scar - part 1 | Experimental | Surgical scar - part 1 Receives: Procedure: Pulsed dye laser treatment |
| Surgical scar - part 2 | Placebo comparator | Surgical scar - part 2 Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician global assessment for the treated and control region (PhGA)
Measured: Before start of the study, 1 and 6 months after treatment
Patient global assessment for the treated and control region (PGA)
Measured: Before start of the study, 1 and 6 months after treatment
Secondary outcomes (4)
Assessment of scar color by colorimetry
Measured: Before start of the study, 1 and 6 months after treatment.
Assessment of scar tickness by ultrasound measurements
Measured: Before start of the study, 1 and 6 months after treatment.
Assessment of viscoelasticity by Cutometer measurements
Measured: Before start of the study, 1 and 6 months after treatment.
Clinical scar assessment by the Vancouver Scar scale and POSAS scale.
Measured: Before the start of the PDL treatment, and 1 and 6 months after the last treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startNov 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical ScarsStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Evelien Verhaeghe, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201525
- Sponsor's protocol ID
- 2009/218
- Status last verified
- Aug 2011
- First submitted
- 2 Dec 2009
- Last updated
- 10 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Dye Laser Treatment of Recent Surgical Scars: A Prospective Single Blinded Within Patient Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT01201525
- Acronym / sponsor ID
- 2009/218
- Conditions
- Surgical Scars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 14 Sep 2010 (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.
Hypothesis: Improvement of recent surgical scars after treatment with 595nm Pulsed dye laser treatments.
Study design: Prospective single blinded within patient controlled randomised trial. Recent surgical scars of at least 5cm will be divided into 2 parts and randomized. 1 part will be treated with 4 595nm Pulsed dye laser treatments on a 4 weeks interval. The other part will serve as a within patient control. 1 and 6 months after the intervention both parts of the scar will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical scar - part 1 | Experimental | Procedure: Pulsed dye laser treatmentSurgical scar - part 1 |
| Surgical scar - part 2 | Placebo comparator | Procedure: ControlSurgical scar - part 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with planned surgical intervention leaving a scar from at least 5 cm in an area prone to hypertrophic scarring : neck, shoulders, chest, mandibular angle and extremities
- Age at least 18 years old.
- Patient able and willing to give written informed consent
Key exclusion criteria (4 listed)
- Patients with planned surgical intervention on hands, feet and genital area
- Patients with a history of photodermatoses
- Patients with a history of keloids
- Patients with a history of adverse outcomes related to PDL
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 |
|---|---|---|
| Pulsed dye laser treatmentPart 1 of the surgical scar will be treated with 4 595nm Pulsed dye laser treatments. | Procedure or surgery | Surgical scar - part 1 |
| ControlPart 2 of the surgical scar will serve as a within patient control. | Procedure or surgery | Surgical scar - part 2 |
Primary outcome
Physician global assessment for the treated and control region (PhGA)
Time frame: Before start of the study, 1 and 6 months after treatment
Patient global assessment for the treated and control region (PGA)
Time frame: Before start of the study, 1 and 6 months after treatment
4 secondary outcomes
Assessment of scar color by colorimetry
Time frame: Before start of the study, 1 and 6 months after treatment.
Assessment of scar tickness by ultrasound measurements
Time frame: Before start of the study, 1 and 6 months after treatment.
Assessment of viscoelasticity by Cutometer measurements
Time frame: Before start of the study, 1 and 6 months after treatment.
Clinical scar assessment by the Vancouver Scar scale and POSAS scale.
Time frame: Before the start of the PDL treatment, and 1 and 6 months after the last treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2011.
- website of the University Hospital GhentLink provided by the sponsor.
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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.
Evelien Verhaeghe, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed dye laser treatment in people with Surgical Scars, run by University Hospital, Ghent at 1 site in Belgium.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 10 Aug 2011. 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 Belgium. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician global assessment for the treated and control region (PhGA) (time frame: Before start of the study, 1 and 6 months after treatment). 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 Aug 2011.