Recruiting

Silicone Taping

Sponsor:

Nova Scotia Health Authority

Code:

NCT04506255

Conditions

Hypertrophic Scar

Scar

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Silicone tape

Study Details

Brief summary:

This study will look at silicone tape compared to the current no dressing standard at the investigators institution, to determine if silicone tape provides a significant improvement in post-abdominoplasty scar appearance. Silicone tape will be added to half of the abdominoplasty incision of patients undergoing abdominally-based breast reconstruction procedures two weeks after their operation. They will be followed up and assessed at specific timepoints to determine whether the silicone improves scar outcomes in these patients.

Conditions

Hypertrophic Scar

Scar

Study ID

NCT04506255

Start date

Nov 16, 2020

Status verified date

Feb, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • undergoing de novo abdominoplasty procedures as part of their breast reconstruction

Exclusion Criteria:

  • patients with a history of collagen disease, connective tissue disorders, psoriasis or lupus
  • patients with scleroderma
  • patients with a history of adverse reaction to adhesives or silicone allergy
  • patients with signs of dehiscence or infection resulting in modification to the experimental or control dressings
  • patients who are unable to care for their incisions
  • patients who are current smokers
  • patients who are currently on steroids.

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Silicone tape

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.

no intervention: No dressing

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.

Interventions

Silicone tape

Medical grade tape with silicone adhesive

Primary outcome measure

  • Patient and Observer Scar Assessment Scale (PSAS & OSAS) System [ Time Frame: 6 week follow up, 3 months, 6 months and 12 months. ]
  • Patient and Observer Scar Assessment Scale (PSAS & OSAS) System [ Time Frame: 3 month follow up ]
  • Patient and Observer Scar Assessment Scale (PSAS & OSAS) System [ Time Frame: 6 month follow up ]
  • Patient and Observer Scar Assessment Scale (PSAS & OSAS) System [ Time Frame: 12 month follow up ]

Central Contacts and Locations

Central contacts

Jason G Williams, MD

902-473-6315Jason.Williams@nshealth.ca

Emily Burke, MD

902-694-8080Emily.Burke@dal.ca

Locations

Halifax Infirmary

Recruiting

Halifax, Nova Scotia, Canada, B3H 3A7

Contacts

Jason Williams

902-473-6315

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Feb 18, 2025

Last verified

Feb, 2025

Keywords

  • Silicone
  • Scar
  • Abdominoplasty
  • Breast Reconstruction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2025-02-18.