Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID04506255

Silicone Taping for the Improvement of Abdominal Donor Site Scars Following Autologous Breast Reconstruction; A Randomized, Prospective Controlled Trial

Led by Nova Scotia Health Authority · Updated on 2025-02-18

32

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether silicone tape can improve the appearance of abdominal scars after abdominoplasty procedures performed as part of breast reconstruction. This prospective, randomized, controlled trial compares silicone tape applied to one half of the incision with no dressing on the other half, which is the current standard care. The study includes adults undergoing autologous free-flap breast reconstruction and aims to determine if silicone tape enhances scar quality over time. Participants will receive silicone tape on one half of their abdominoplasty incision starting two weeks after surgery, applying it daily for two and a half months. The other half of the incision will receive no dressing. Patients will remove the tape for showers and reapply it after drying. Each patient acts as their own control, and the side receiving tape is randomly chosen. Masking is maintained for the surgeon assessing the scars, with patients removing dressings a day before assessments. Participants will be followed up at 6 weeks, 3 months, 6 months, and 12 months after surgery. Scar assessments are done by both patients and masked surgeons using the Patient and Observer Scar Assessment Scale (PSAS & OSAS), which evaluates factors like color, thickness, pain, pigmentation, and vascularity. Research coordinators will address questions at each visit. The primary outcome is the OSAS scar score sum, with secondary outcomes including the PSAS score and overall ratings from both patient and surgeon.

CONDITIONS

Brief Title

Silicone Taping for the Improvement of Abdominal Donor Site Scars

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Undergoing de novo abdominoplasty procedures as part of breast reconstruction
Not Eligible

You will not qualify if you...

  • History of collagen disease, connective tissue disorders, psoriasis, or lupus
  • Diagnosis of scleroderma
  • History of adverse reaction to adhesives or silicone allergy
  • Signs of wound dehiscence or infection affecting dressings
  • Inability to care for incisions
  • Current smoker
  • Current use of steroids

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - Day of surgery

Participants undergo a de novo abdominoplasty procedure as part of autologous breast reconstruction.

1 visit (in-person)

Implementation

Duration - 2.5 months starting 2 weeks post-operatively

Two weeks after surgery, participants have one half of their abdominal incision randomized to receive daily silicone tape application, while the other half receives no dressing. Participants apply silicone tape daily for two and a half months.

1 post-operative visit at 2 weeks to receive randomization and instructions

Post-operative Follow-up

Duration - Up to 12 months post-surgery

Participants attend follow-up visits for scar assessment performed by both the patient and masked surgeon using validated scar scales.

Follow-up visits at 6 weeks, 3 months, 6 months, and 12 months

Trial Site Locations

Total: 1 location

1

Halifax Infirmary

Halifax, Nova Scotia, Canada, B3H 3A7

Actively Recruiting

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Research Team

J

Jason G Williams, MD

E

Emily Burke, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

A randomized controlled trial of the embrace advanced scar therapy device to reduce incisional scar formation.

Michael T Longaker, Rod J Rohrich, Lauren Greenberg...

https://pubmed.ncbi.nlm.nih.gov/24804638