An interventional study of Fractional CO2 laser in Cleft Lip Post-surgical Scar, sponsored by Assiut University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2020-04-21.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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.
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)
Exclusion Criteria:
Fractional CO2 laser will be applied on cleft lip scar 3 weeks post-surgical
Radiation: Fractional CO2 laser
Fractional CO2 laser will be applied on cleft lip scar 3 months post-surgical
Radiation: Fractional CO2 laser
No intervention
Fractional CO2 laser will be applied in cleft lip scar to assess and evaluate the later appearance of the scar
Vancouver scar scale
It assess four variables:vascularity , height/thickness , pigmentation , pliability
Time frame: 5 -7 months
Visual analogue scale
This depends on 5 independent medical and nonmedical personnel rating results on a graded scale 0-10
Time frame: 5-7 months
Plan to share: Yes
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Assiut University