Comparison of Cosmetic and Functional Outcome of Silicone Sheeting and Micro-needling on Hypertrophic Scars

NCT05108272 | Unknown

• 1 other identifier: FUI/CTR/2021/2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Hypertrophic Scar

Outcome Measures

Primary Outcomes (1)

• 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.

  3 Months

Secondary Outcomes (2)

• Itching at scar site

  3 Months

• Pain At scar Site

  3 Months

Study Arms (2)

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.

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

Procedure: Microneedling

Interventions

Microneedling PROCEDURE

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

Also known as: Percutaneous Induction

Microneedling

Percutaneous Collagen Induction PROCEDURE

It is self-adhesive sheet made from medical graded Silicone. It has micropore technology which entraps moisture where it is needed on scared skin.

Silicone Sheeting

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (2)

Foundation University Islamabad

Islamabad, Federal, 46000, Pakistan

NOT YET RECRUITING

FFH

Rawalpindi, Punjab Province, Pakistan

RECRUITING

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Interventions

Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Central Study Contacts

Ayesha Aslam

CONTACT

+923335171053; whitepearl_2003@yahoo.com

Ahmed Ali

CONTACT

+923449438579; royal_drali@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: November 4, 2021
• Study Start: July 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: March 30, 2022
• Last Updated: November 4, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)