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

Cannula-based Versus Common Needle-based Subcision in the Treatment of Posttraumatic Atrophic Facial Scars: A Clinical Trial

This study aims to evaluate the effectiveness of cannula- based subcision versus common needle subcision in treatment of posttraumatic atrophic facial scars

Study Overview

• Status: Completed
• Conditions: Scar; Atrophy
• Intervention / Treatment: Procedure: cannula- based subcision; Procedure: common- needle based subcision

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 82524
    • Sohag University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cannula arm; 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.	Procedure: cannula- based subcision; Insertion of a needle into the base of a cutaneous scar to cut fibrous tissue and help new collagen formation.
Active Comparator: Needle arm; 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.	Procedure: common- needle based subcision; Insertion of a cannula into the base of a cutaneous scar to cut fibrous tissue and help new collagen formation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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) .	4 months

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: Marwa Mohamed, MD, Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: February 17, 2023
• First Posted (Estimate): February 28, 2023

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: subatrophic001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No