Cleft Lip Post-surgical ScarNCT03277287
Assessment of Fractional CO2 Laser in Treatment of Post-surgical Scarring of Cleft Lip
A study testing Fractional CO2 laser in people with Cleft Lip Post-surgical Scar, run by Assiut University at 1 site in Egypt.
Trial summary
This is a prospective comparative study on 120 patients divided to three groups. Group A: 40 patients laser will be applied 3 weeks post-surgical. Group B: 40 patients laser will be applied 3 months post surgical. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cleft Lip Post-surgical Scar
- What is being tested?
- Fractional CO2 laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2017to 15 Feb 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any age with acceptable scar which would not need further revision.
- Group A: three weeks after repair \& group B: three months after repair with no hypertrophy, erythema or any other scar complication.
Who cannot join
- Any case with deformity needing further surgical interference.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective comparative study on 120 patients divided to three groups. Group A: 40 patients laser will be applied 3 weeks post-surgical. Group B: 40 patients laser will be applied 3 months post surgical. Group C: 40 patients as a control not treated with laser from 2017 to 2020 which will be conducted on patients with post-surgical cleft lip repair scaring.
All patients will have 5-7 sessions with 4 weeks interval.
Photographic documentation and evaluation of the scar will occur every 4 weeks.
Read the detailed description
The carbon dioxide laser (CO2 Laser) was one of the earliest gas lasers to be developed. It was invented by Kumar Patel of Bell Labs in 1964.
CO2 laser is the highest power continuous wave lasers that are currently available which produces a beam of infrared light with the principal wavelength bands centering on 9.4 and 10.6 micrometers. Patel, C. K. N. (1964).
When CO2 beam of light is selectively applied to the skin, it heats and vaporizes various layers of skin, instantly treating damaged skin and wrinkles while smoothing out the surface of the skin.
The skin remodeling occurs with new skin and collagen growth. The healing typically involves an open surface which takes weeks to heal and typically results in loss of the baseline pigmentation leading to variable lightening of skin. Dover, J. S. (2012) Fractional CO2 laser resurfacing is a revolutionary delivery system that provides dramatic skin improvement without surgery. Matrix combines the benefits of CO2 laser by using micro laser columns "points of light" to treat the epidermis and dermal layers of your skin.
Bernstein et al, (1997) Cleft lip is a form of lip malformation that occurs very early in pregnancy, the incidence of cleft lip in the population is approximately 0.5-2 in 1000 live births. Male children are affected more often than female children.
Michalski AM et al, (2015). Because each cleft is unique, definitive repair of the cleft lip should be individualized as Mirault, Le Mesurier, Tennison, and Millard.
Stal S et al, (2009)
- Conditions
- Cleft Lip Post-surgical Scar
- Being tested
- Fractional CO2 laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional CO2 laserRadiation
Fractional CO2 laser will be applied in cleft lip scar to assess and evaluate the later appearance of the scar
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Fractional CO2 laser will be applied on cleft lip scar 3 weeks post-surgical Receives: Radiation: Fractional CO2 laser |
| Group B | Experimental | Fractional CO2 laser will be applied on cleft lip scar 3 months post-surgical Receives: Radiation: Fractional CO2 laser |
| Group C | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vancouver scar scale
It assess four variables:vascularity , height/thickness , pigmentation , pliability
Measured: 5 -7 months
Secondary outcomes (1)
Visual analogue scale
This depends on 5 independent medical and nonmedical personnel rating results on a graded scale 0-10
Measured: 5-7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start1 Sep 2017
- Primary completion30 Jan 2020
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cleft Lip Post-surgical ScarStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Factorial
- Model description
- Prospective comparative study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Shadad Rateb Mohamed, Assiut University
- Investigators
- Wagdi Ali, Dr, Study director, Assiut UniversityMohamed Elshazly, Prof., Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277287
- Sponsor's protocol ID
- CO2 laser in cleft lip scar
- Status last verified
- Apr 2020
- First submitted
- 6 Sep 2017
- Last updated
- 21 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Shadad M, Ali WM, Fayyaz GQ, El-Shazly M. Use of Fractional CO2 Laser in Cleft Lip Scars: Does It Make a Difference? Ann Plast Surg. 2021 May 1;86(5):536-539. doi: 10.1097/SAP.0000000000002511.
PubMed 32826442
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Fractional CO2 Laser in Treatment of Post-surgical Scarring of Cleft Lip
- ClinicalTrials.gov ID
- NCT03277287
- Acronym / sponsor ID
- CO2 laser in cleft lip scar
- Conditions
- Cleft Lip Post-surgical Scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 11 Sep 2017 (actual)
- 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.
This is a prospective comparative study on 120 patients divided to three groups. Group A: 40 patients laser will be applied 3 weeks post-surgical. Group B: 40 patients laser will be applied 3 months post surgical. Group C: 40 patients as a control not treated with laser from 2017 to 2020 which will be conducted on patients with post-surgical cleft lip repair scaring.
All patients will have 5-7 sessions with 4 weeks interval.
Photographic documentation and evaluation of the scar will occur every 4 weeks.
Detailed description
The carbon dioxide laser (CO2 Laser) was one of the earliest gas lasers to be developed. It was invented by Kumar Patel of Bell Labs in 1964.
CO2 laser is the highest power continuous wave lasers that are currently available which produces a beam of infrared light with the principal wavelength bands centering on 9.4 and 10.6 micrometers. Patel, C. K. N. (1964).
When CO2 beam of light is selectively applied to the skin, it heats and vaporizes various layers of skin, instantly treating damaged skin and wrinkles while smoothing out the surface of the skin.
The skin remodeling occurs with new skin and collagen growth. The healing typically involves an open surface which takes weeks to heal and typically results in loss of the baseline pigmentation leading to variable lightening of skin. Dover, J. S. (2012) Fractional CO2 laser resurfacing is a revolutionary delivery system that provides dramatic skin improvement without surgery. Matrix combines the benefits of CO2 laser by using micro laser columns "points of light" to treat the epidermis and dermal layers of your skin.
Bernstein et al, (1997) Cleft lip is a form of lip malformation that occurs very early in pregnancy, the incidence of cleft lip in the population is approximately 0.5-2 in 1000 live births. Male children are affected more often than female children.
Michalski AM et al, (2015). Because each cleft is unique, definitive repair of the cleft lip should be individualized as Mirault, Le Mesurier, Tennison, and Millard.
Stal S et al, (2009)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Prospective comparative study
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Radiation: Fractional CO2 laserFractional CO2 laser will be applied on cleft lip scar 3 weeks post-surgical |
| Group B | Experimental | Radiation: Fractional CO2 laserFractional CO2 laser will be applied on cleft lip scar 3 months post-surgical |
| Group C | No intervention | –No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Any age with acceptable scar which would not need further revision.
- Group A: three weeks after repair \& group B: three months after repair with no hypertrophy, erythema or any other scar complication.
Key exclusion criteria (1 listed)
- Any case with deformity needing further surgical interference.
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 |
|---|---|---|
| Fractional CO2 laserFractional CO2 laser will be applied in cleft lip scar to assess and evaluate the later appearance of the scar | Radiation | Group A, Group B |
Primary outcome
Vancouver scar scale
Time frame: 5 -7 months
It assess four variables:vascularity , height/thickness , pigmentation , pliability
1 secondary outcome
Visual analogue scale
Time frame: 5-7 months
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 21 Apr 2020.
- Derived from this study: PubMed 32826442Shadad M, Ali WM, Fayyaz GQ, El-Shazly M. Use of Fractional CO2 Laser in Cleft Lip Scars: Does It Make a Difference? Ann Plast Surg. 2021 May 1;86(5):536-539. doi: 10.1097/SAP.0000000000002511.
- Individual participant dataSharing planned: Yes
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Cleft Lip, Cleft Lip Scar
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.
Wagdi Ali, Dr study director
Assiut University
Mohamed Elshazly, Prof. principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional CO2 laser in people with Cleft Lip Post-surgical Scar, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 1 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 21 Apr 2020. 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 Egypt. 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?
Vancouver scar scale (time frame: 5 -7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03277287, which also lists 1 linked publication.
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 21 Apr 2020.