Post-Traumatic ScarNCT06135480
Subcision With PRP and Microneedling Versus Subcision With Saline and Micro-needling in Treatment of Posttraumatic Scars
A study testing subcision ,PRP or saline and microneedling in people with Post-Traumatic Scar, run by Assiut University at 1 site in Egypt.
Trial summary
Compare different minimally invasive approaches to reach optimum improvement by comparing the efficacy and safety of both combined subcision with platelet-rich plasma and microneedling versus combined subcision with saline and microneedling in the treatment of post-traumatic scars. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Post-Traumatic Scar
- What is being tested?
- subcision ,PRP or saline and microneedling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 30 Mar 2024
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with posttraumatic scars
- Age more than 12 years
Who cannot join
- Patients with platelet or blood clotting disorders, and chronic liver or autoimmune diseases.
- Patients with chronic debilitating diseases, uncontrolled systemic infection, or keloid tendency or with unrealistic expectations.
- Pregnant females.
- Patients who did not complete the treatment sessions or the follow-up period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subcision With Platelet-Rich Plasma and Microneedling Versus Subcision With Saline and Micro-needling in Treatment of Posttraumatic Scars: Randomized Clinical Trial
Compare different minimally invasive approaches to reach optimum improvement by comparing the efficacy and safety of both combined subcision with platelet-rich plasma and microneedling versus combined subcision with saline and microneedling in the treatment of post-traumatic scars.
Read the detailed description
The scars at the level of the skin represent a normal and inevitable process of healing traumatic or surgical lesions, but except for the appearance of the skin, they also have a profound psychological impact . Thus, people with scars try to integrate them into their sense of self to gain psychological acceptance .
Many treatment options have been developed for the management of traumatic scars .Surgical intervention is an invasive technique, surgery has a high risk of inducing new scar formation .
Non-surgical approaches for the treatment of traumatic scars include topical treatments and minimally invasive approached as subcision,microneedling and laser.
Autologous platelet-rich plasma is plasma with a higher concentration of platelets than normally found, it can enhance wound healing which has been demonstrated in controlled studies for soft and hard tissues . The application of autologous platelet-rich plasma to surgical wounds has been shown to accelerate tissue repair and reduce postoperative pain .
Subcision is a procedure in which a needle is inserted under the skin and passed in multiple directions . Although subcision is adequate as a stand-alone treatment, improved results are achieved when it is combined with other modalities.
Microneedling is a percutaneous collagen induction therapy that causes skin resurfacing. It involves using fine needles to create controlled microdermal injuries starting a complex cascade of growth factors that end in collagen remodeling .
Because of the different treatment options available for this common problem, the current work aimed to combine and compare different minimally invasive approaches to reach optimum improvement.
- Conditions
- Post-Traumatic Scar
- Being tested
- subcision ,PRP or saline and microneedling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcision ,PRP or saline and microneedlingOther
minimally invasive procedures
| Study group | Role | What they receive |
|---|---|---|
| combined subcision with platelet-rich plasma and microneedling group | Active comparator | Not described Receives: Other: subcision ,PRP or saline and microneedling |
| combined subcision with saline and microneedling group | Active comparator | Not described Receives: Other: subcision ,PRP or saline and microneedling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar severity grading
Scar severity grading will be evaluated by blinded dermatologist
Measured: after 1 month of treatment completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Nov 2023
- Primary completion28 Feb 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic ScarStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Howida Omar Twisy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135480
- Sponsor's protocol ID
- Post traumatic scars treatment
- Status last verified
- Jul 2024
- First submitted
- 12 Nov 2023
- Last updated
- 31 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Twisy HO. Subcision with platelet-rich plasma and microneedling versus subcision with saline and micro-needling in posttraumatic scars. Arch Dermatol Res. 2024 Aug 19;316(8):537. doi: 10.1007/s00403-024-03226-3.
PubMed 39158761
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcision With Platelet-Rich Plasma and Microneedling Versus Subcision With Saline and Micro-needling in Treatment of Posttraumatic Scars: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06135480
- Acronym / sponsor ID
- Post traumatic scars treatment
- Conditions
- Post-Traumatic Scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 18 Nov 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.
Compare different minimally invasive approaches to reach optimum improvement by comparing the efficacy and safety of both combined subcision with platelet-rich plasma and microneedling versus combined subcision with saline and microneedling in the treatment of post-traumatic scars.
Detailed description
The scars at the level of the skin represent a normal and inevitable process of healing traumatic or surgical lesions, but except for the appearance of the skin, they also have a profound psychological impact . Thus, people with scars try to integrate them into their sense of self to gain psychological acceptance .
Many treatment options have been developed for the management of traumatic scars .Surgical intervention is an invasive technique, surgery has a high risk of inducing new scar formation .
Non-surgical approaches for the treatment of traumatic scars include topical treatments and minimally invasive approached as subcision,microneedling and laser.
Autologous platelet-rich plasma is plasma with a higher concentration of platelets than normally found, it can enhance wound healing which has been demonstrated in controlled studies for soft and hard tissues . The application of autologous platelet-rich plasma to surgical wounds has been shown to accelerate tissue repair and reduce postoperative pain .
Subcision is a procedure in which a needle is inserted under the skin and passed in multiple directions . Although subcision is adequate as a stand-alone treatment, improved results are achieved when it is combined with other modalities.
Microneedling is a percutaneous collagen induction therapy that causes skin resurfacing. It involves using fine needles to create controlled microdermal injuries starting a complex cascade of growth factors that end in collagen remodeling .
Because of the different treatment options available for this common problem, the current work aimed to combine and compare different minimally invasive approaches to reach optimum improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined subcision with platelet-rich plasma and microneedling group | Active comparator | Other: subcision ,PRP or saline and microneedling |
| combined subcision with saline and microneedling group | Active comparator | Other: subcision ,PRP or saline and microneedling |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with posttraumatic scars
- Age more than 12 years
Key exclusion criteria (4 listed)
- Patients with platelet or blood clotting disorders, and chronic liver or autoimmune diseases.
- Patients with chronic debilitating diseases, uncontrolled systemic infection, or keloid tendency or with unrealistic expectations.
- Pregnant females.
- Patients who did not complete the treatment sessions or the follow-up period.
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 |
|---|---|---|
| subcision ,PRP or saline and microneedlingminimally invasive procedures | Other | combined subcision with platelet-rich plasma and microneedling group, combined subcision with saline and microneedling group |
Primary outcome
Scar severity grading
Time frame: after 1 month of treatment completion.
Scar severity grading will be evaluated by blinded dermatologist
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 31 Jul 2024.
- Derived from this study: PubMed 39158761Twisy HO. Subcision with platelet-rich plasma and microneedling versus subcision with saline and micro-needling in posttraumatic scars. Arch Dermatol Res. 2024 Aug 19;316(8):537. doi: 10.1007/s00403-024-03226-3.
- Individual participant dataSharing planned: No
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Scars
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subcision ,PRP or saline and microneedling in people with Post-Traumatic Scar, run by Assiut 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 2 inclusion and 4 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 31 Jul 2024. 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?
Scar severity grading (time frame: after 1 month of treatment completion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06135480, which also lists 1 linked publication.
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 31 Jul 2024.