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/24804638Actively Recruiting
Led by Nova Scotia Health Authority · Updated on 2025-02-18
32
Participants Needed
1
Research Sites
13 weeks
Total Duration
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
Silicone Taping for the Improvement of Abdominal Donor Site Scars
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo a de novo abdominoplasty procedure as part of autologous breast reconstruction.
1 visit (in-person)
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
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
Total: 1 location
1
Halifax Infirmary
Halifax, Nova Scotia, Canada, B3H 3A7
Actively Recruiting
J
Jason G Williams, MD
E
Emily Burke, MD
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
2
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