What side effects are associated with this type of intervention?

Common treatments for scarring, such as silicone tape, chemical peels, injectable fillers, and nonablative skin resurfacing, have various side effects. Silicone tape, which improves scars through hydration and occlusion, may cause skin irritation or allergic reactions. Chemical peels can lead to redness, peeling, and temporary discomfort. Injectable fillers might result in bruising, swelling, and, in rare cases, nodule formation or vascular complications. Nonablative skin resurfacing typically causes mild erythema and edema, which usually resolve within a few days. It is important to discuss these potential side effects with a healthcare provider to determine the most suitable treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for scarring that focus on hydration and occlusion, similar to silicone tape. These include silicone gel sheets and silicone ointments, which create a protective barrier over the scar, maintaining moisture and promoting healing. Products like Mederma and ScarAway are examples of silicone-based treatments that have been widely used and studied for their efficacy in improving the appearance of scars.

What other types of research exist?

Promising alternatives to silicone tape for scar improvement include: <ol> <li>Polyacrylamide hydrogel: Shown to be effective and safe for soft-tissue augmentation and scar treatment.</li> <li></li> </ol> Hyaluronic acid fillers: Used for soft tissue augmentation, providing hydration and promoting collagen synthesis. 3. Platelet-rich fibrin matrix (PRFM): Enhances healing and improves scar appearance by promoting tissue regeneration. 4. Poly-L-lactic acid (PLLA): Demonstrated long-term efficacy in improving skin texture and reducing scar severity.

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Silicone Taping for Abdominal Scars

N/A

Recruiting

Led By Jason G Williams, MD

Research Sponsored by Nova Scotia Health Authority

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

undergoing de novo abdominoplasty procedures as part of their breast reconstruction

Be older than 18 years old

Must not have

patients who are unable to care for their incisions

patients with scleroderma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month follow up

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if silicone tape can make scars look better after breast reconstruction surgery. Patients will use the tape on part of their surgical scar. The study will check the scars over time to see if the tape helps. Silicone materials, including tapes and implants, have been widely used in breast reconstruction surgeries to improve outcomes and patient satisfaction.

Who is the study for?

This trial is for individuals getting new abdominoplasty as part of breast reconstruction. It's not suitable for those with scleroderma, open wounds or infections at the surgery site, inability to care for incisions, current smokers, steroid users, or a history of collagen disease, connective tissue disorders (like psoriasis or lupus), or silicone adhesive allergies.

What is being tested?

The study tests if silicone tape can improve the appearance of scars after abdominoplasty compared to no dressing. Participants will have silicone tape applied to half their surgical scar two weeks post-operation and will be monitored over time to assess scar healing.

What are the potential side effects?

Potential side effects may include skin irritation or allergic reactions specific to those sensitive to adhesives or silicone. However, since it's a non-invasive treatment, severe side effects are unlikely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having a tummy tuck as part of my breast reconstruction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot take care of my surgical wounds by myself.

Select...

I have scleroderma.

Select...

I am currently taking steroids.

Select...

I have signs of wound reopening or infection that required changes to my wound care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Patient and Observer Scar Assessment Scale (PSAS & OSAS) System

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Silicone tapeExperimental Treatment1 Intervention

Adult subjects will act as their own control and will be randomized to have silicone tape applied to one half of their abdominoplasty incision. Patients will apply silicone tape on a daily basis, with each piece lasting 24 hours. Tape may be removed for showers and replied after drying. Total length of treatment will be two and a half months.

Group II: No dressingActive Control1 Intervention

Control treatment using the current standard of care at our institution to the other half, which is no dressing after the initial two week post-op period, will be used on the other half of the incision for comparison. Each individual patient will act as their own control.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for scarring, such as silicone tape, work primarily through hydration and occlusion. Silicone tape helps to hydrate the scar tissue, which can soften and flatten the scar, making it less noticeable. The occlusive nature of the tape also protects the scar from external irritants and reduces collagen production, which can prevent excessive scar formation. These mechanisms are crucial for scarring patients as they can significantly improve the appearance and texture of scars, enhancing both aesthetic outcomes and patient confidence.

Platelet-rich plasma in noninvasive procedures for atrophic acne scars: A systematic review and meta-analysis.