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Cannula-based Versus Needle-based Subcision for Posttraumatic Atrophic Facial Scars

Primary Purpose

Scar; Atrophy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
cannula- based subcision
common- needle based subcision
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scar; Atrophy

Eligibility Criteria

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

Inclusion Criteria: Adult Patients (> 20-years old) with posttraumatic facial scar Exclusion Criteria: other types of scars (e.g; postacne scars), pregnancy, lactation, bleeding or coagulation disorders, liability for keloid formation, history of kobnerization, and patients with systemic diseases (cardiac, chronic renal diseases, chronic liver diseases, asthma and hypertension) at the time of recruitment.

Sites / Locations

  • Sohag University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cannula arm

Needle arm

Arm Description

the cannula's 18 gauge tip was pointed upward and approximately parallel to the skin's surface when it was put into the superficial dermis, 1-2 millimeters away from the targeted scar. In order to completely remove fibrous tissue from the superficial dermis, a lancing motion (linear inserting-withdrawing needle action) was utilized first.

The needle's 27 gauge tip was pointed upward and approximately parallel to the skin's surface when it was put into the superficial dermis, 1-2 millimeters away from the targeted scar. In order to completely remove fibrous tissue from the superficial dermis, a lancing motion (linear inserting-withdrawing needle action) was utilized first.

Outcomes

Primary Outcome Measures

Vancouver scar scale (VSS)
The (VSS) examines vascularity, pliability, pigmentation, and height, yielding a total score that ranges from 0 to 14. The original rating system was as follows: Vascularity (0=normal, 1=pink, 2=red, 3=purple), Pliability (Normal=0, Flat=0, Supple=1, Yielding=2, Firm=3, Ropes=4, Contracture=5), Pigmentation (0=normal, 1=hypo-pigmentation, 2=mixed pigmentation, 3=hyper-pigmentation), and Height (Flat=0 <2 mm=1 2-5 mm=2 >5 mm=2) .

Secondary Outcome Measures

Full Information

First Posted
February 17, 2023
Last Updated
February 17, 2023
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05747898
Brief Title
Cannula-based Versus Needle-based Subcision for Posttraumatic Atrophic Facial Scars
Official Title
Cannula-based Versus Common Needle-based Subcision in the Treatment of Posttraumatic Atrophic Facial Scars: A Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

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

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
This study aims to evaluate the effectiveness of cannula- based subcision versus common needle subcision in treatment of posttraumatic atrophic facial scars
Detailed Description
In addition to cosmetic issues, atrophic scars can lead to psychological issues like social isolation, low self-esteem, and embarrassment. Subcision (Subcutaneous incision-less surgery) has been used for years to treat a variety of skin depressions, including atrophic acne scars and other depressed scars. Numerous modifications have been made throughout time to this surgical method to make it easier and more efficient. Although needle subcision is a straightforward, simple, useful, and practical procedure, it has many side effects and the overall success in this procedure is mild to moderate. So, in this study we evaluated the effectiveness of cannula- based subcision versus common needle subcision in treatment of posttraumatic atrophic facial scars.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar; Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Each scar was split into two equal halves; the upper right half were treated using a cannula- based subcision approach, while the lower left half was treated using a common needle-based procedure
Masking
Outcomes Assessor
Masking Description
The assessor was blinded to the treatment applied to each half of the scar.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cannula arm
Arm Type
Active Comparator
Arm Description
the cannula's 18 gauge tip was pointed upward and approximately parallel to the skin's surface when it was put into the superficial dermis, 1-2 millimeters away from the targeted scar. In order to completely remove fibrous tissue from the superficial dermis, a lancing motion (linear inserting-withdrawing needle action) was utilized first.
Arm Title
Needle arm
Arm Type
Active Comparator
Arm Description
The needle's 27 gauge tip was pointed upward and approximately parallel to the skin's surface when it was put into the superficial dermis, 1-2 millimeters away from the targeted scar. In order to completely remove fibrous tissue from the superficial dermis, a lancing motion (linear inserting-withdrawing needle action) was utilized first.
Intervention Type
Procedure
Intervention Name(s)
cannula- based subcision
Intervention Description
Insertion of a needle into the base of a cutaneous scar to cut fibrous tissue and help new collagen formation.
Intervention Type
Procedure
Intervention Name(s)
common- needle based subcision
Intervention Description
Insertion of a cannula into the base of a cutaneous scar to cut fibrous tissue and help new collagen formation.
Primary Outcome Measure Information:
Title
Vancouver scar scale (VSS)
Description
The (VSS) examines vascularity, pliability, pigmentation, and height, yielding a total score that ranges from 0 to 14. The original rating system was as follows: Vascularity (0=normal, 1=pink, 2=red, 3=purple), Pliability (Normal=0, Flat=0, Supple=1, Yielding=2, Firm=3, Ropes=4, Contracture=5), Pigmentation (0=normal, 1=hypo-pigmentation, 2=mixed pigmentation, 3=hyper-pigmentation), and Height (Flat=0 <2 mm=1 2-5 mm=2 >5 mm=2) .
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult Patients (> 20-years old) with posttraumatic facial scar Exclusion Criteria: other types of scars (e.g; postacne scars), pregnancy, lactation, bleeding or coagulation disorders, liability for keloid formation, history of kobnerization, and patients with systemic diseases (cardiac, chronic renal diseases, chronic liver diseases, asthma and hypertension) at the time of recruitment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwa Mohamed, MD
Organizational Affiliation
Sohag University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sohag University
City
Sohag
ZIP/Postal Code
82524
Country
Egypt

12. IPD Sharing Statement

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Cannula-based Versus Needle-based Subcision for Posttraumatic Atrophic Facial Scars

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