Scars After Surgical InterventionNCT01639105
10 600 nm Ablative Fractional Laser Treatment of Scars: a Prospective Single Blinded Within Patient Controlled Randomized Trial
A study testing Laser treatment in people with Scars After Surgical Intervention, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Rationale The cosmetic aspect of scars is a frequent reason for consultation. It plays an important role in patient satisfaction and self-image. Several treatment modalities are proposed for scars with variable success. Ablative fractional laser treatment is a rather new concept. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scars After Surgical Intervention
- What is being tested?
- Laser treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2012to Jul 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Scars caused by surgical intervention, that are 2 months old
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Rationale The cosmetic aspect of scars is a frequent reason for consultation. It plays an important role in patient satisfaction and self-image. Several treatment modalities are proposed for scars with variable success.
Ablative fractional laser treatment is a rather new concept. Many microscopic small laser beams target the dermis in a grid pattern. The vertical columns of skin hit by the laser beams heat up. This thermal effect stimulates the wound healing and potentially leads to a remodeling of the skin structure.
Read more
Ablative fractional laser treatment has been used successfully for treatment of pigment changes, wrinkles, acne scars and thermal burn wounds. It has been reported that CO2 ablative fractional laser treatment has a positive clinical effect on various types of scars however this has not been proven yet in a prospective randomized trial. The low morbidity of the treatment and the lack of convincing adapted treatment modalities for various types of scars make this treatment attractive.
That's why the investigators aim with this randomized study to evaluate the clinical effect and the safety of 10 600 nm ablative fractional laser therapy for patients with recent scars due to surgical interventions.
Goal Evaluate the efficacy of three 10 600 nm ablative fractional laser treatments for the above mentioned scars, three months after the last laser treatment, with a prospective randomized intra-patient controlled study.
Study design Prospective single blinded randomized intra-patient controlled study. The study comprises 4 study visits.
Study population The population consists of one group of patients with scars after recent surgical operations. The patients must meet the inclusion and exclusion criteria described in the protocol.
Method The scar will be divided in two equal halves. The two halves will be randomized. One part will not be treated. The other part will undergo three times the 10 600 nm ablative laser therapy with 4 weeks interval between the treatments. The efficacy of the treatment will be evaluated three months after the last treatment with objective and subjective parameters.
Most important study endpoints:
- Evaluation of the efficacy of the treatment. A blinded clinical scar evaluation will be done of the treated and untreated parts with the POSAS scar scale, by a study collaborator and by the patient himself, on a category scale of 0 to 10 (0 = normal skin, 10 = worst scar imaginable), before start and twelve weeks after the last treatment.
- Evaluation of the pain related to the treatment. The pain will be scored by the patient with the VAS category scale from 0 to 10 (0 = no pain, 10 = worst pain ever).
- Evaluation of the side effects of the treatment. A standardized form will be used.
- Evaluation of the global patient satisfaction regarding the treatment.
- Clinical photos, before start and twelve weeks after the last treatment.
- Conditions
- Scars After Surgical Intervention
- Being tested
- Laser treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser treatmentProcedure or surgery
10 600 NM ABLATIEVE FRACTIONATED LASER
| Study group | Role | What they receive |
|---|---|---|
| treated half of the scar | Experimental | Not described Receives: Procedure: Laser treatment |
| untreated half of the scar | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical aspect of the scar 3 months after the last laser treatment
POSAS scar scale
Measured: 3 months after the last laser treatment
Secondary outcomes (3)
Pain
VAS scale for pain measurement
Measured: 3 months after the last laser treatment
Number and severity of side effects
Will be measured by clinical photographs
Measured: 3 months after the last laser treatment
satisfaction
Will be measured with the standardized satisfaction scale
Measured: 3 months after the last laser treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scars After Surgical InterventionStudies 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Boone, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639105
- Sponsor's protocol ID
- 2012/395
- Status last verified
- Jan 2023
- First submitted
- 10 Jul 2012
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 10 600 nm Ablative Fractional Laser Treatment of Scars: a Prospective Single Blinded Within Patient Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT01639105
- Acronym / sponsor ID
- 2012/395
- Conditions
- Scars After Surgical Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 12 Jul 2012 (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.
Rationale The cosmetic aspect of scars is a frequent reason for consultation. It plays an important role in patient satisfaction and self-image. Several treatment modalities are proposed for scars with variable success.
Ablative fractional laser treatment is a rather new concept. Many microscopic small laser beams target the dermis in a grid pattern. The vertical columns of skin hit by the laser beams heat up. This thermal effect stimulates the wound healing and potentially leads to a remodeling of the skin structure.
Ablative fractional laser treatment has been used successfully for treatment of pigment changes, wrinkles, acne scars and thermal burn wounds. It has been reported that CO2 ablative fractional laser treatment has a positive clinical effect on various types of scars however this has not been proven yet in a prospective randomized trial. The low morbidity of the treatment and the lack of convincing adapted treatment modalities for various types of scars make this treatment attractive.
That's why the investigators aim with this randomized study to evaluate the clinical effect and the safety of 10 600 nm ablative fractional laser therapy for patients with recent scars due to surgical interventions.
Goal Evaluate the efficacy of three 10 600 nm ablative fractional laser treatments for the above mentioned scars, three months after the last laser treatment, with a prospective randomized intra-patient controlled study.
Study design Prospective single blinded randomized intra-patient controlled study. The study comprises 4 study visits.
Study population The population consists of one group of patients with scars after recent surgical operations. The patients must meet the inclusion and exclusion criteria described in the protocol.
Method The scar will be divided in two equal halves. The two halves will be randomized. One part will not be treated. The other part will undergo three times the 10 600 nm ablative laser therapy with 4 weeks interval between the treatments. The efficacy of the treatment will be evaluated three months after the last treatment with objective and subjective parameters.
Most important study endpoints:
- Evaluation of the efficacy of the treatment. A blinded clinical scar evaluation will be done of the treated and untreated parts with the POSAS scar scale, by a study collaborator and by the patient himself, on a category scale of 0 to 10 (0 = normal skin, 10 = worst scar imaginable), before start and twelve weeks after the last treatment.
- Evaluation of the pain related to the treatment. The pain will be scored by the patient with the VAS category scale from 0 to 10 (0 = no pain, 10 = worst pain ever).
- Evaluation of the side effects of the treatment. A standardized form will be used.
- Evaluation of the global patient satisfaction regarding the treatment.
- Clinical photos, before start and twelve weeks after the last treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treated half of the scar | Experimental | Procedure: Laser treatment |
| untreated half of the scar | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scars caused by surgical intervention, that are 2 months old
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 |
|---|---|---|
| Laser treatment10 600 NM ABLATIEVE FRACTIONATED LASER | Procedure or surgery | treated half of the scar |
Primary outcome
Clinical aspect of the scar 3 months after the last laser treatment
Time frame: 3 months after the last laser treatment
POSAS scar scale
3 secondary outcomes
Pain
Time frame: 3 months after the last laser treatment
Number and severity of side effects
Time frame: 3 months after the last laser treatment
satisfaction
Time frame: 3 months after the last laser 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 6 Jan 2023.
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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.
Barbara Boone, MD, PhD 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 Laser treatment in people with Scars After Surgical Intervention, 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 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: finished, as of the sponsor's last update on 6 Jan 2023. 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. 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?
Clinical aspect of the scar 3 months after the last laser treatment (time frame: 3 months after the last laser treatment). 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 6 Jan 2023.