Completed

NCT Number: NCT03277287

Assessment of Fractional CO2 Laser in Treatment of Post-surgical Scarring of Cleft Lip

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.

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Key information

Conditions

Cleft Lip Post-surgical Scar

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohamed shadad

Asyut, Egypt

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fractional CO2 laser

Radiation

Fractional CO2 laser will be applied in cleft lip scar to assess and evaluate the later appearance of the scar

Primary outcomes

Vancouver scar scale

Time frame: 5 -7 months

It assess four variables:vascularity , height/thickness , pigmentation , pliability

Secondary outcomes

Visual analogue scale

Time frame: 5-7 months

This depends on 5 independent medical and nonmedical personnel rating results on a graded scale 0-10

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2020
First posted: Sep 11, 2017
Registry last updated: Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.