Silicone Taping for the Improvement of Abdominal Donor Site Scars

NCT04506255 | Recruiting

• 1 other identifier: 1025794
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

Silicone; Scar; Abdominoplasty; Breast Reconstruction

Outcome Measures

Primary Outcomes (4)

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

  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.

  6 week follow up, 3 months, 6 months and 12 months.

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

  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.

  3 month follow up

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

  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.

  6 month follow up

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

  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.

  12 month follow up

Secondary Outcomes (4)

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

  6 week follow up

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

  3 month follow up

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

  6 month follow up

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

  12 month follow up

Study Arms (2)

Silicone tape

EXPERIMENTAL

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.

Device: Silicone tape

No dressing

NO 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.

Interventions

Silicone tape DEVICE

Medical grade tape with silicone adhesive

Silicone tape

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Halifax Infirmary

Halifax, Nova Scotia, B3H 3A7, Canada

RECRUITING

Related Publications (19)

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MeSH Terms

Conditions

Cicatrix, Hypertrophic; Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jason G Williams, MD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason G Williams, MD

CONTACT

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

Emily Burke, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Staff surgeons who are responsible for assessing outcomes will be masked to which side is receiving the silicone tape. At the initial two-week post-op visit, patients will meet with the research coordinator for randomization assignments of their incisions. Surgeons will be masked to assignments. Patients will remove their dressings one day prior to their appointment with their surgeon. This will ensure no local reaction (i.e. redness after tape removal) that would compromise the masking of staff surgeons.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigation

Model Details: This is a prospective, single center, masked, randomized self-controlled clinical human trial to evaluate the appearance of abdominal scars after autologous free-flap breast reconstruction following post-operative application of silicone tape to improve scar quality.

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 10, 2020
• Study Start: November 16, 2020
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)