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

Cleft Lip Post-surgical Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03277287
• Other study ID #: CO2 laser in cleft lip scar
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: February 15, 2020

Study information

• Verified date: April 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 15, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip Post-surgical Scar

Intervention

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

Locations

Country	Name	City	State
Egypt	Mohamed shadad	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vancouver scar scale	It assess four variables:vascularity , height/thickness , pigmentation , pliability	5 -7 months
Secondary	Visual analogue scale	This depends on 5 independent medical and nonmedical personnel rating results on a graded scale 0-10	5-7 months