Scar; AtrophyNCT05747898
Cannula-based Versus Needle-based Subcision for Posttraumatic Atrophic Facial Scars
A study testing cannula- based subcision and common- needle based subcision in people with Scar; Atrophy, run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effectiveness of cannula- based subcision versus common needle subcision in treatment of posttraumatic atrophic facial scars Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Scar; Atrophy
- What is being tested?
- cannula- based subcision and common- needle based subcision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Patients (> 20-years old) with posttraumatic facial scar
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Scar; Atrophy
- Being tested
- cannula- based subcision, common- needle based subcision
- Medical subject headings
- Cicatrix, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cannula- based subcisionProcedure or surgery
Insertion of a needle into the base of a cutaneous scar to cut fibrous tissue and help new collagen formation.
common- needle based subcisionProcedure or surgery
Insertion of a cannula into the base of a cutaneous scar to cut fibrous tissue and help new collagen formation.
| Study group | Role | What they receive |
|---|---|---|
| Cannula arm | Active comparator | 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. Receives: Procedure: cannula- based subcision |
| Needle arm | Active comparator | 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. Receives: Procedure: common- needle based subcision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start1 Nov 2021
- Primary completion30 Oct 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scar; AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohamed, Sohag University
- Investigators
- Marwa Mohamed, MD, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747898
- Sponsor's protocol ID
- subatrophic001
- Status last verified
- Feb 2023
- First submitted
- 17 Feb 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannula-based Versus Common Needle-based Subcision in the Treatment of Posttraumatic Atrophic Facial Scars: A Clinical Trial
- ClinicalTrials.gov ID
- NCT05747898
- Acronym / sponsor ID
- subatrophic001
- Conditions
- Scar; Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Cannula arm | Active comparator | Procedure: cannula- based subcisionthe 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. |
| Needle arm | Active comparator | Procedure: common- needle based subcisionThe 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult Patients (> 20-years old) with posttraumatic facial scar
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cannula- based subcisionInsertion of a needle into the base of a cutaneous scar to cut fibrous tissue and help new collagen formation. | Procedure or surgery | Cannula arm |
| common- needle based subcisionInsertion of a cannula into the base of a cutaneous scar to cut fibrous tissue and help new collagen formation. | Procedure or surgery | Needle arm |
Primary outcome
Vancouver scar scale (VSS)
Time frame: 4 months
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) .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa Mohamed, MD principal investigator
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cannula- based subcision and common- needle based subcision in people with Scar; Atrophy, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vancouver scar scale (VSS) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.