Back to resultsThe Effect of Centella Asiatica Cream on Scar Tenderness Who Underwent Open Carpal Tunnel Release Surgery
Primary Purpose
To Prevent Scar Formation for Patients Underwent Surgery
Status
Completed
Phase
Early Phase 1
Locations
Turkey
Study Type
Interventional
Intervention
undefinedCentella Asiatica Extract
Sponsored by
About this trial
This is an interventional treatment trial for To Prevent Scar Formation for Patients Underwent Surgery focused on measuring carpal tunnel syndrome, centella asiatica, surgery, cosmetic outcome, wound healing
Eligibility Criteria
Inclusion Criteria: patient underwent open carpal tunnel release surgery -
Exclusion Criteria:before hand surgery and recurrent carpal tunnel release surgery.
-
Sites / Locations
- Mustafa Balevi,MD
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
vss
QuickDASH , VAS
Arm Description
Vancouver Scar Scale (VSS) at the one, three and 6 months after surgery
, Quick Disabilities of Arm Shoulder and Hand functional score (QuickDASH) and Visual Analogue Scale (VAS) test was used to determine overall hand function, activities of daily living, work performance, pain, aesthetics, and satisfaction with hand function
Outcomes
Primary Outcome Measures
centella asiatica extrate
treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT05017467
First Posted
April 10, 2021
Last Updated
August 20, 2021
Sponsor
Mustafa Balevi,MD
Collaborators
Konya Numune Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05017467
Brief Title
The Effect of Centella Asiatica Cream on Scar Tenderness Who Underwent Open Carpal Tunnel Release Surgery
Official Title
The Effect of Centella Asiatica Cream on Scar Tenderness in Patients Who Underwent Open Carpal Tunnel Release Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2011 (Actual)
Primary Completion Date
January 5, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mustafa Balevi,MD
Collaborators
Konya Numune Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The centella asiatica cream applied to the wrist after the CTR surgery was found to be beneficial in preventing the scar tenderness in the thenar and hypothenar regions of the hand.
Detailed Description
Aim: This study was performed to evaluate the efficacy of centella asiatica extract in a cream preparation for the prevention of scar tenderness formation in patients who underwent conventional open carpal tunnel release surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
To Prevent Scar Formation for Patients Underwent Surgery
Keywords
carpal tunnel syndrome, centella asiatica, surgery, cosmetic outcome, wound healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
280 operated patient with carpal tunnel release surgery.
Masking
Participant
Masking Description
280
Allocation
Randomized
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vss
Arm Type
Experimental
Arm Description
Vancouver Scar Scale (VSS) at the one, three and 6 months after surgery
Arm Title
QuickDASH , VAS
Arm Type
Experimental
Arm Description
, Quick Disabilities of Arm Shoulder and Hand functional score (QuickDASH) and Visual Analogue Scale (VAS) test was used to determine overall hand function, activities of daily living, work performance, pain, aesthetics, and satisfaction with hand function
Intervention Type
Drug
Intervention Name(s)
undefinedCentella Asiatica Extract
Other Intervention Name(s)
centella asiatica extract
Intervention Description
All patients were asked about scar hypertrophy, scar tenderness, and pillar pain.
The scar assessment was performed using the Vancouver Scar Scale (VSS) at the one, three and 6 months after surgery.
Patients were asked to complete pre- and postoperative functional evaluations. The VAS score and QuickDASH test was used
Primary Outcome Measure Information:
Title
centella asiatica extrate
Description
treatment
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patient underwent open carpal tunnel release surgery -
Exclusion Criteria:before hand surgery and recurrent carpal tunnel release surgery.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Balevi
Organizational Affiliation
İstanbul Medipol Üniversity,Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mustafa Balevi,MD
City
Konya
State/Province
Meram
ZIP/Postal Code
42090
Country
Turkey
City
Konya
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Centella Asiatica Cream on Scar Tenderness Who Underwent Open Carpal Tunnel Release Surgery
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