The Effect of Centella Asiatica Cream on Scar Tenderness Who Underwent Open Carpal Tunnel Release Surgery

August 20, 2021 updated by: Mustafa Balevi,MD

The Effect of Centella Asiatica Cream on Scar Tenderness in Patients Who Underwent Open Carpal Tunnel Release Surgery

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Konya, Turkey
    • Meram
      • Konya, Meram, Turkey, 42090
        • Mustafa Balevi,MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria: patient underwent open carpal tunnel release surgery -

Exclusion Criteria:before hand surgery and recurrent carpal tunnel release surgery.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: vss
Vancouver Scar Scale (VSS) at the one, three and 6 months after surgery

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

Other Names:
  • centella asiatica extract
EXPERIMENTAL: QuickDASH , VAS
, 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

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

Other Names:
  • centella asiatica extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
centella asiatica extrate
Time Frame: 10 years
treatment
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Ali Balevi, İstanbul Medipol Üniversity,Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2011

Primary Completion (ACTUAL)

January 5, 2020

Study Completion (ACTUAL)

April 1, 2020

Study Registration Dates

First Submitted

April 10, 2021

First Submitted That Met QC Criteria

August 20, 2021

First Posted (ACTUAL)

August 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 23, 2021

Last Update Submitted That Met QC Criteria

August 20, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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