Assessment of Fractional CO2 Laser in Treatment of Post-surgical Scarring of Cleft Lip
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedFirst Submitted
Initial submission to the registry
September 6, 2017
CompletedFirst Posted
Study publicly available on registry
September 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2020
CompletedApril 21, 2020
April 1, 2020
2.4 years
September 6, 2017
April 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Vancouver scar scale
It assess four variables:vascularity , height/thickness , pigmentation , pliability
5 -7 months
Secondary Outcomes (1)
Visual analogue scale
5-7 months
Study Arms (3)
Group A
EXPERIMENTALFractional CO2 laser will be applied on cleft lip scar 3 weeks post-surgical
Group B
EXPERIMENTALFractional CO2 laser will be applied on cleft lip scar 3 months post-surgical
Group C
NO INTERVENTIONNo intervention
Interventions
Fractional CO2 laser will be applied in cleft lip scar to assess and evaluate the later appearance of the scar
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Any case with deformity needing further surgical interference.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mohamed shadad
Asyut, Egypt
Related Publications (1)
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.
PMID: 32826442DERIVED
Study Officials
- STUDY DIRECTOR
Wagdi Ali, Dr
Assiut University
- PRINCIPAL INVESTIGATOR
Mohamed Elshazly, Prof.
Assiut University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident doctor
Study Record Dates
First Submitted
September 6, 2017
First Posted
September 11, 2017
Study Start
September 1, 2017
Primary Completion
January 30, 2020
Study Completion
February 15, 2020
Last Updated
April 21, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will share