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

Not Applicable

Completed

• Conditions: Cleft Lip Post-surgical Scar
• Interventions: Radiation: Fractional CO2 laser

• Registration Number: NCT03277287
• Lead Sponsor: Assiut University

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)

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2017-09-06
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-11
• Primary Completion: 2020-01-30
• Study Completion: 2020-02-15
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-17
• Last Update Posted: 2020-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Read More

Exclusion Criteria

• Any case with deformity needing further surgical interference.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group B	Fractional CO2 laser	Fractional CO2 laser will be applied on cleft lip scar 3 months post-surgical
Group A	Fractional CO2 laser	Fractional CO2 laser will be applied on cleft lip scar 3 weeks post-surgical

Primary Outcome Measures

Name	Time	Method
Vancouver scar scale	5 -7 months	It assess four variables:vascularity , height/thickness , pigmentation , pliability

Secondary Outcome Measures

Name	Time	Method
Visual analogue scale	5-7 months	This depends on 5 independent medical and nonmedical personnel rating results on a graded scale 0-10

Trial Locations

Locations (1)

Mohamed shadad; 🇪🇬 Assiut, Egypt