Assessment of Fractional CO2 Laser in Treatment of Post-s... | NCT03277287

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

NCT03277287

Sponsor

Assiut University

Status

Completed

Last Update Posted

Apr 21, 2020Actual

Enrollment

120Actual

Phase

Not Applicable

Conditions

Cleft Lip Post-surgical Scar

Interventions

Fractional CO2 laser

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Jan 30, 2020Actual

Completion Date

Feb 15, 2020Actual

First Submitted Date

Sep 6, 2017

First Submission Date that Met QC Criteria

Sep 8, 2017

First Posted Date

Sep 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2020

Last Update Posted Date

Apr 21, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed Shadad Rateb Mohamed, Resident doctor, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Fractional CO2 laser will be applied on cleft lip scar 3 weeks post-surgical	Radiation: Fractional CO2 laser
Group B	Experimental	Fractional CO2 laser will be applied on cleft lip scar 3 months post-surgical	Radiation: Fractional CO2 laser
Group C	No Intervention	No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fractional CO2 laser	Radiation	Fractional CO2 laser will be applied in cleft lip scar to assess and evaluate the later appearance of the scar	Group A Group B

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wagdi Ali, Dr	Assiut University	Study Director
Mohamed Elshazly, Prof.	Assiut University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mohamed shadad		Asyut			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32826442	Derived	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.