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

Foundation University Islamabad

Status: Unknown

Conditions: Hypertrophic Scar

Treatments: Procedure: Percutaneous Collagen Induction; Procedure: Microneedling

Study type: Interventional

Funder types: Other

Identifiers

NCT05108272

FUI/CTR/2021/2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. All the patients presenting with hypertrophic scars ≥1cm in size
2. Any age
3. Both genders

Exclusion criteria:

1. Pregnant or lactating mothers
2. Patients who already taking systemic steroid as confirmed through clinical record
3. Patients with renal failure or liver failure as confirmed through clinical history
4. Patient with uncontrolled diabetes.
5. Patients who received treatment for keloids or hypertrophic scar in past.
6. Patients with active inflammation in area of hypertrophic scar or in its vicinity.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

Silicone Sheeting

Active Comparator group

Description:

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.

Treatment:

Procedure: Percutaneous Collagen Induction

Microneedling

Experimental group

Description:

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

Treatment:

Procedure: Microneedling