Hypertrophic ScarNCT05108272
Comparison of Cosmetic and Functional Outcome of Silicone Sheeting and Micro-needling on Hypertrophic Scars
A study testing Microneedling and Percutaneous Collagen Induction in people with Hypertrophic Scar, run by Foundation University Islamabad at 2 sites in Pakistan.
Trial summary
Hypertrophic scars and keloids are frequently encountered in plastic surgery OPD. due to any reason, the normal wound healing is impaired, hypertrophic scars or keloids occur. These are thickened, wide and raised scars. Many treatment options are presented over time, but most of the treatments remain insufficient. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertrophic Scar
- What is being tested?
- Microneedling and Percutaneous Collagen Induction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Jul 2021to 30 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Pregnant or lactating mothers
- Patients who already taking systemic steroid as confirmed through clinical record
- Patients with renal failure or liver failure as confirmed through clinical history
- Patient with uncontrolled diabetes.
- Patients who received treatment for keloids or hypertrophic scar in past.
- Patients with active inflammation in area of hypertrophic scar or in its vicinity.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 2 recruiting
- Not yet recruiting
Foundation University Islamabad
Islamabad, Federal, 46000
Ayesha Aslam, +923335171053, whitepearl_2003@yahoo.com
- Recruiting
FFH
Rawalpindi, Punjab Province
Ayesha Aslam, 923335171053
About this study
Hypertrophic scars and keloids are frequently encountered in plastic surgery OPD. due to any reason, the normal wound healing is impaired, hypertrophic scars or keloids occur. These are thickened, wide and raised scars. Many treatment options are presented over time, but most of the treatments remain insufficient. Treatment options include massage therapy, silicone sheet, occlusive dressings, pressure garments, adhesive tape, intra-lesional steroid injections, laser therapy, cryotherapy, radiotherapy, 5-fluorouracil, interferons, bleomycin, imiquimod 5%cream, tranilast, botulin toxin and surgical excision. In this Study outcomes of treatment with silicone sheeting and microneedling will be compaired.
Read the detailed description
Hypertrophic scars and keloids are one of difficult conditions to treat. Prevention of abnormal scaring is more effective than treatment, so avoiding unnecessary wounds in patients is a solution but flawed one. Many treatment options are presented over time, but most of the treatments remain insufficient. Treatment options include massage therapy, silicone sheet, occlusive dressings, pressure garments, adhesive tape, intra-lesional steroid injections, laser therapy, cryotherapy, radiotherapy, 5-fluorouracil, interferons, bleomycin, imiquimod 5%cream, tranilast, botulin toxin and surgical excision. Silicone sheeting is considered first line therapy of hypertrophic scar. It works by maintaining hydration and occlusion at scar site. But silicone sheeting is expensive and need 12 to 24 hours of constant application daily for at least 2 months for desired results. Level 1, 2 and 3 evidences show newer technique 'percutaneous collagen induction(micro-needling)', shows significant improvement in hypertrophic scars. Micro-needling causes controlled dermal injury to initiate inflammatory and healing reaction, which in turn leads to remodelling of collagen and stimulate regeneration of scared skin. Silicone sheets is an expensive treatment requiring multiple applications and are often difficult to use in hot and humid environment. These reasons often lead to poor patient compliance. Keeping these issues in mind we planned to study an alternative option i.e. micro-needling, which is relatively of low cost and better patient acceptability. When doing the literature review the investigator found scanty evidence so the investigator decided to perform this RCT.
- Conditions
- Hypertrophic Scar
- Being tested
- Microneedling, Percutaneous Collagen Induction
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroneedlingProcedure or surgery
Also called Percutaneous Induction
Derma Pen is an electric device, used for microneedling. Derma pen has a Cartridge which has microneedles fitted. These needles penetrate the skin upto 2mm
Percutaneous Collagen InductionProcedure or surgery
It is self-adhesive sheet made from medical graded Silicone. It has micropore technology which entraps moisture where it is needed on scared skin.
| Study group | Role | What they receive |
|---|---|---|
| Silicone Sheeting | Active comparator | After explaining and taking consent from the patient about the intervention, pre intervention assessment will be made. Silicone gel sheet (Rystoraº) will be used at scar wound for 16 hours every day for 3 months. After 3 months post intervention assessment will be made. Receives: Procedure: Percutaneous Collagen Induction |
| Microneedling | Experimental | After explaining and taking consent from the patient about the intervention, pre- intervention assessment will be made. Derma pen (Dr.Pen auto Microneedle system Ultima-A6) with 36 needles per cm2 will be used with adjustable depth of 0.5mm to 2mm. Micro-needling will be performed in 3 axis,1st in vertical, then horizontal and then oblique direction to the point of uniform petechial bleed. Four sessions at 3 weekly intervals will be performed. Final assessment will be made after 3 months of first intervention Receives: Procedure: Microneedling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cosmetic Outcome
It will be assessed using, Vancouver scar scale at time of presentation and at 3 months after the intervention. Pre and post intervention ratings will be compared and percentage increase or decrease in the rating will be documented. Vancouver Scar Scale is a 13 points scale and includes four parameters, pigmentation, vascularity pliability and height of scar.13 It is an objective scale and examining doctor will assess and record score out of 13. Lesser the score better is the scar.
Measured: 3 Months
Secondary outcomes (2)
Itching at scar site
It will be assessed at the time of presentation and at 3 months after the intervention using severity of pruritus scale. It is 4 point rating scale from 0 (no itch) to 3(severe itch disturbing the sleep) assessing severity of pruritus within 24-hours recall period. Pre and post intervention ratings will be compared and percentage increase or decrease in the rating will be documented.
Measured: 3 Months
Pain At scar Site
Patient will be asked to rate his/her current, best and worst pain level over past 24 hours on scale of 0 (no pain) to 10 (worst pain imaginable). Pain at scar site will be assessed at time of presentation and then at 3 months after start of the treatment. Pre and post intervention ratings will be compared and percentage increase or decrease in the rating will be documented. This scale is chosen due to its high feasibility and good compliance.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start1 Jul 2021
- Primary completion28 Feb 2022 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic ScarStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108272
- Sponsor's protocol ID
- FUI/CTR/2021/2
- Status last verified
- Nov 2021
- First submitted
- 17 Aug 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cosmetic and Functional Outcome of Silicone Sheeting and Micro-needling on Hypertrophic Scars
- ClinicalTrials.gov ID
- NCT05108272
- Acronym / sponsor ID
- FUI/CTR/2021/2
- Conditions
- Hypertrophic Scar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 4 Nov 2021 (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.
Hypertrophic scars and keloids are frequently encountered in plastic surgery OPD. due to any reason, the normal wound healing is impaired, hypertrophic scars or keloids occur. These are thickened, wide and raised scars. Many treatment options are presented over time, but most of the treatments remain insufficient. Treatment options include massage therapy, silicone sheet, occlusive dressings, pressure garments, adhesive tape, intra-lesional steroid injections, laser therapy, cryotherapy, radiotherapy, 5-fluorouracil, interferons, bleomycin, imiquimod 5%cream, tranilast, botulin toxin and surgical excision. In this Study outcomes of treatment with silicone sheeting and microneedling will be compaired.
Detailed description
Hypertrophic scars and keloids are one of difficult conditions to treat. Prevention of abnormal scaring is more effective than treatment, so avoiding unnecessary wounds in patients is a solution but flawed one. Many treatment options are presented over time, but most of the treatments remain insufficient. Treatment options include massage therapy, silicone sheet, occlusive dressings, pressure garments, adhesive tape, intra-lesional steroid injections, laser therapy, cryotherapy, radiotherapy, 5-fluorouracil, interferons, bleomycin, imiquimod 5%cream, tranilast, botulin toxin and surgical excision. Silicone sheeting is considered first line therapy of hypertrophic scar. It works by maintaining hydration and occlusion at scar site. But silicone sheeting is expensive and need 12 to 24 hours of constant application daily for at least 2 months for desired results. Level 1, 2 and 3 evidences show newer technique 'percutaneous collagen induction(micro-needling)', shows significant improvement in hypertrophic scars. Micro-needling causes controlled dermal injury to initiate inflammatory and healing reaction, which in turn leads to remodelling of collagen and stimulate regeneration of scared skin. Silicone sheets is an expensive treatment requiring multiple applications and are often difficult to use in hot and humid environment. These reasons often lead to poor patient compliance. Keeping these issues in mind we planned to study an alternative option i.e. micro-needling, which is relatively of low cost and better patient acceptability. When doing the literature review the investigator found scanty evidence so the investigator decided to perform this RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silicone Sheeting | Active comparator | Procedure: Percutaneous Collagen InductionAfter explaining and taking consent from the patient about the intervention, pre intervention assessment will be made. Silicone gel sheet (Rystoraº) will be used at scar wound for 16 hours every day for 3 months. After 3 months post intervention assessment will be made. |
| Microneedling | Experimental | Procedure: MicroneedlingAfter explaining and taking consent from the patient about the intervention, pre- intervention assessment will be made. Derma pen (Dr.Pen auto Microneedle system Ultima-A6) with 36 needles per cm2 will be used with adjustable depth of 0.5mm to 2mm. Micro-needling will be performed in 3 axis,1st in vertical, then horizontal and then oblique direction to the point of uniform petechial bleed. Four sessions at 3 weekly intervals will be performed. Final assessment will be made after 3 months of first intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Pregnant or lactating mothers
- Patients who already taking systemic steroid as confirmed through clinical record
- Patients with renal failure or liver failure as confirmed through clinical history
- Patient with uncontrolled diabetes.
- Patients who received treatment for keloids or hypertrophic scar in past.
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 |
|---|---|---|
| MicroneedlingAlso: Percutaneous InductionDerma Pen is an electric device, used for microneedling. Derma pen has a Cartridge which has microneedles fitted. These needles penetrate the skin upto 2mm | Procedure or surgery | Microneedling |
| Percutaneous Collagen InductionIt is self-adhesive sheet made from medical graded Silicone. It has micropore technology which entraps moisture where it is needed on scared skin. | Procedure or surgery | Silicone Sheeting |
Primary outcome
Cosmetic Outcome
Time frame: 3 Months
It will be assessed using, Vancouver scar scale at time of presentation and at 3 months after the intervention. Pre and post intervention ratings will be compared and percentage increase or decrease in the rating will be documented. Vancouver Scar Scale is a 13 points scale and includes four parameters, pigmentation, vascularity pliability and height of scar.13 It is an objective scale and examining doctor will assess and record score out of 13. Lesser the score better is the scar.
2 secondary outcomes
Itching at scar site
Time frame: 3 Months
Pain At scar Site
Time frame: 3 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedling and Percutaneous Collagen Induction in people with Hypertrophic Scar, run by Foundation University Islamabad at 2 sites in Pakistan.
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 0 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayesha Aslam (+923335171053, whitepearl_2003@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cosmetic Outcome (time frame: 3 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 4 Nov 2021.