Silicone tape: Medical grade tape with silicone adhesive
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Patient and Observer Scar Assessment Scale (PSAS & OSAS) System — 6 week follow up, 3 months, 6 months and 12 months. The POSAS is a tool that the patient uses to assess the scar on color, irregularity, itch, pain, thickness, stiffness and overall opinion, and the surgeon uses to assess pigmentation, pliability, relief, surface area, thickness, vascularity and overall opinion. Each component is scored out of 10, with a lower score indicating a better scar. Of note, only the sum of the components of the OSAS portion of the assessment scale is included to calculate the power and sample size, and will therefore be the primary outcome.
Patient and Observer Scar Assessment Scale (PSAS & OSAS) System — 3 month follow up The POSAS is a tool that the patient uses to assess the scar on color, irregularity, itch, pain, thickness, stiffness and overall opinion, and the surgeon uses to assess pigmentation, pliability, relief, surface area, thickness, vascularity and overall opinion. Each component is scored out of 10, with a lower score indicating a better scar. Of note, only the sum of the components of the OSAS portion of the assessment scale is included to calculate the power and sample size, and will therefore be the primary outcome.
Patient and Observer Scar Assessment Scale (PSAS & OSAS) System — 6 month follow up The POSAS is a tool that the patient uses to assess the scar on color, irregularity, itch, pain, thickness, stiffness and overall opinion, and the surgeon uses to assess pigmentation, pliability, relief, surface area, thickness, vascularity and overall opinion. Each component is scored out of 10, with a lower score indicating a better scar. Of note, only the sum of the components of the OSAS portion of the assessment scale is included to calculate the power and sample size, and will therefore be the primary outcome.
Patient and Observer Scar Assessment Scale (PSAS & OSAS) System — 12 month follow up The POSAS is a tool that the patient uses to assess the scar on color, irregularity, itch, pain, thickness, stiffness and overall opinion, and the surgeon uses to assess pigmentation, pliability, relief, surface area, thickness, vascularity and overall opinion. Each component is scored out of 10, with a lower score indicating a better scar. Of note, only the sum of the components of the OSAS portion of the assessment scale is included to calculate the power and sample size, and will therefore be the primary outcome.
Trial sites (1)
Facility
City
Region
Status
Halifax Infirmary
Halifax
Nova Scotia
Recruiting
More Nova Scotia Health Authority trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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