NCT05108272

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Foundation University Islamabad · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
PROCEDURE	Microneedling	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
PROCEDURE	Percutaneous Collagen Induction	It is self-adhesive sheet made from medical graded Silicone. It has micropore technology which entraps moisture where it is needed on scared skin.

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-02-28
• Completion: 2022-03-30
• First posted: 2021-11-04
• Last updated: 2021-11-04

Locations

2 sites across 1 country: Pakistan