Clinical trial NCT03277287: Assessment of Fractional CO2 Laser in Treatment of Post-surgical Scarring of Cleft Lip
Official title: Assessment of Fractional CO2 Laser in Treatment of Post-surgical Scarring of Cleft Lip
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cleft Lip Post-surgical Scar
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-09-11
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Prospective comparative study
Primary purpose: TREATMENT

Brief 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. 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)

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Any case with deformity needing further surgical interference.

Primary outcomes:
measure: Vancouver scar scale
timeFrame: 5 -7 months
Secondary outcomes:
measure: Visual analogue scale
timeFrame: 5-7 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Mohamed shadad
Study officials:
affiliation: Assiut University
name: Wagdi Ali, Dr
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Mohamed Elshazly, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.