Silicone Taping for Abdominal Scars

Recruiting in Palo Alto (17 mi)

Overseen by Jason G Williams, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Nova Scotia Health Authority

Must not be taking: Steroids

Disqualifiers: Collagen disease, Connective tissue disorders, Psoriasis, Lupus, others

No Placebo Group

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. ^{1 2 3 4 5}

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. ^{2 6 7 8 9}

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. ^{1 2 3 10 11}

Research Team

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.

Trial 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 (Other)

Trial Overview 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.

Participant Groups

Group I: Silicone tape Experimental Treatment 1 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 dressing Active Control 1 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.

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Karen Oldfield

Nova Scotia Health Authority

Chief Executive Officer since 2021

Past Chair of the Board of Governors of Saint Mary’s University

Dr. Robert Strang

Nova Scotia Health Authority

Chief Medical Officer

MD

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 60 adult patients, silicone tape caused significantly less skin injury compared to standard acrylate tapes, with only 0% experiencing skin denudation versus 13.3% with standard tapes.

Patients reported higher satisfaction with silicone tape for both eyelid and facial skin conditions, scoring an average of 4.53 and 4.57 respectively, compared to 3.83 and 3.87 for standard tapes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Medical Adhesive Tapes in Patients at Risk of Facial Skin Trauma under Anesthesia. Zeng, LA., Lie, SA., Chong, SY.[2020]

The FDA has classified silicone sheeting for managing hypertrophic and keloid scars as a class I medical device, which means it is subject to general controls and does not require premarket notification.

This classification streamlines the process for bringing silicone sheeting to market, potentially increasing access for patients seeking treatment for problematic scars.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

General and plastic surgery devices; classification of silicone sheeting. Final rule. [2004]

A study involving eight hypertrophic scars showed that a topical self-drying silicone gel significantly reduced scar thickness by an average of 37% after 6 months of treatment.

The results indicate that this silicone gel, applied twice daily, is both effective and well-tolerated, suggesting it could be a safe treatment option for hypertrophic scars, although further research with larger patient groups is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Lacarrubba, F., Patania, L., Perrotta, R., et al.[2016]

In a study involving 10 individuals with linear scars less than one year old, silicone gel sheets did not show significant improvements in scar healing compared to untreated sides, except for observer ratings of overall scar opinion.

While participants noted some improvements in color, stiffness, and irregularities over time, the silicone gel sheets specifically did not enhance pliability or pigmentation compared to untreated scars, suggesting they may not be effective for normal scar healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linear scar reduction using silicone gel sheets in individuals with normal healing. Maher, SF., Dorko, L., Saliga, S.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A diabetic foot ulcer pilot study: does silicone gel sheeting reduce the incidence of reulceration? [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of Silicone Sheets and Paper Tape for the Management of Postoperative Scars: A Randomized Comparative Study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Can a Cohesive Silicone Bandage Outperform an Adhesive Silicone Gel Sheet in the Treatment of Scars? A Randomized Comparative Trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of effectiveness of silicone gel sheeting with microporous paper tape in the prevention of hypertrophic scarring in a rabbit model. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of silicone gel on burn scars. [2009]

6. India pubmed.ncbi.nlm.nih.gov

Comparison of Two Types of Tapes for Taping After Breast Reconstruction Using Silicone Materials. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison of Medical Adhesive Tapes in Patients at Risk of Facial Skin Trauma under Anesthesia. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a new silicone adhesive tape among clinicians caring for patients with fragile or at-risk skin. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

General and plastic surgery devices; classification of silicone sheeting. Final rule. [2004]

10. England pubmed.ncbi.nlm.nih.gov

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]

11. England pubmed.ncbi.nlm.nih.gov

Linear scar reduction using silicone gel sheets in individuals with normal healing. [2022]