32 Participants Needed

Silicone Taping for Abdominal Scars

EB
JG
Overseen ByJason G Williams, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently on steroids.

What data supports the effectiveness of the treatment Silicone tape for abdominal scars?

Research shows that silicone-based treatments, like silicone gel sheets and cohesive silicone bandages, are effective in improving scar appearance and elasticity in various types of scars, including those from burns and surgeries. This suggests that silicone tape might also be beneficial for abdominal scars.12345

Is silicone tape safe for use on human skin?

Silicone tape is generally considered safe for use on human skin. It is classified by the FDA as a class I device, which means it is subject to general controls and is exempt from premarket notification requirements. Studies have shown that silicone tape causes less skin injury compared to standard tapes, and patients report higher satisfaction with its use.26789

How does silicone taping for abdominal scars differ from other treatments?

Silicone taping for abdominal scars is unique because it involves using a cohesive elastic bandage made of silicone, which may offer better scar elasticity compared to traditional adhesive silicone gel sheets. This method is different from other treatments like silicone gel sheets or paper tape, which are commonly used for managing scars.1231011

Research Team

JG

Jason G Williams, MD

Principal Investigator

Nova Scotia Health Authority

Eligibility Criteria

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.

Inclusion Criteria

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

Exclusion Criteria

You have a history of certain autoimmune diseases such as lupus, psoriasis, or connective tissue disorders.
I cannot take care of my surgical wounds by myself.
I have scleroderma.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive silicone tape treatment on one half of their abdominoplasty incision for scar improvement

10 weeks
Daily application by participants

Follow-up

Participants are monitored for scar assessment at multiple timepoints

12 months
Visits at 6 weeks, 3 months, 6 months, and 12 months

Treatment Details

Interventions

  • Silicone tape
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials
302
Recruited
95,300+

Findings from Research

In a pilot study involving 30 diabetic patients with healed foot ulcers, silicone gel sheeting did not reduce the risk of reulceration compared to emollient cream.
In fact, the use of silicone gel sheeting may have potentially increased the risk of reulceration, suggesting it may not be a safe or effective option for preventing ulcer recurrence in this patient population.
A diabetic foot ulcer pilot study: does silicone gel sheeting reduce the incidence of reulceration?Westphal, C., Neame, IM., Harrison, JC., et al.[2019]
In a randomized controlled trial involving patients who underwent cesarean sections, silicone sheets were found to improve scar appearance compared to paper tape at 6 and 12 months post-surgery, as measured by the visual analog scale (VAS).
Despite the silicone sheets showing better VAS scores for scar appearance, the differences were statistically significant but not clinically meaningful, indicating that both methods are relatively similar in effectiveness for scar prevention.
Comparison of Silicone Sheets and Paper Tape for the Management of Postoperative Scars: A Randomized Comparative Study.Lin, YS., Ting, PS., Hsu, KC.[2021]
In a study involving 60 patients with burn scars, a cohesive elastic silicone bandage was found to significantly improve vertical elasticity compared to traditional silicone gel sheets, suggesting it may be more effective for scar treatment.
Both treatments showed similar results in subjective assessments and color measurements, but the cohesive bandage's unique design provided better pressure and contact with the skin, enhancing its therapeutic effects.
Can a Cohesive Silicone Bandage Outperform an Adhesive Silicone Gel Sheet in the Treatment of Scars? A Randomized Comparative Trial.Moortgat, P., Meirte, J., Maertens, K., et al.[2021]

References

A diabetic foot ulcer pilot study: does silicone gel sheeting reduce the incidence of reulceration? [2019]
Comparison of Silicone Sheets and Paper Tape for the Management of Postoperative Scars: A Randomized Comparative Study. [2021]
Can a Cohesive Silicone Bandage Outperform an Adhesive Silicone Gel Sheet in the Treatment of Scars? A Randomized Comparative Trial. [2021]
Comparison of effectiveness of silicone gel sheeting with microporous paper tape in the prevention of hypertrophic scarring in a rabbit model. [2019]
Effects of silicone gel on burn scars. [2009]
Comparison of Two Types of Tapes for Taping After Breast Reconstruction Using Silicone Materials. [2022]
Comparison of Medical Adhesive Tapes in Patients at Risk of Facial Skin Trauma under Anesthesia. [2020]
Evaluation of a new silicone adhesive tape among clinicians caring for patients with fragile or at-risk skin. [2019]
General and plastic surgery devices; classification of silicone sheeting. Final rule. [2004]
An open-label pilot study to evaluate the efficacy and tolerability of a silicone gel in the treatment of hypertrophic scars using clinical and ultrasound assessments. [2016]
Linear scar reduction using silicone gel sheets in individuals with normal healing. [2022]