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

Primary Purpose

Cleft Lip Post-surgical Scar

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fractional CO2 laser
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Lip Post-surgical Scar

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mohamed shadad

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Group A

Group B

Group C

Arm Description

Fractional CO2 laser will be applied on cleft lip scar 3 weeks post-surgical

Fractional CO2 laser will be applied on cleft lip scar 3 months post-surgical

No intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 6, 2017
Last Updated
April 17, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03277287
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
February 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip Post-surgical Scar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Prospective comparative study
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Fractional CO2 laser will be applied on cleft lip scar 3 weeks post-surgical
Arm Title
Group B
Arm Type
Experimental
Arm Description
Fractional CO2 laser will be applied on cleft lip scar 3 months post-surgical
Arm Title
Group C
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Radiation
Intervention Name(s)
Fractional CO2 laser
Intervention Description
Fractional CO2 laser will be applied in cleft lip scar to assess and evaluate the later appearance of the scar
Primary Outcome Measure Information:
Title
Vancouver scar scale
Description
It assess four variables:vascularity , height/thickness , pigmentation , pliability
Time Frame
5 -7 months
Secondary Outcome Measure Information:
Title
Visual analogue scale
Description
This depends on 5 independent medical and nonmedical personnel rating results on a graded scale 0-10
Time Frame
5-7 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wagdi Ali, Dr
Organizational Affiliation
Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed Elshazly, Prof.
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mohamed shadad
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
32826442
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.
Results Reference
derived

Learn more about this trial

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

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