Silicone Taping for the Improvement of Abdominal Donor Site Scars
NCT ID: NCT04506255
Last Updated: 2025-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
32 participants
INTERVENTIONAL
2020-11-16
2026-12-31
Brief Summary
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Detailed Description
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Patients will be recruited from plastic surgery clinics at the Queen Elizabeth II (QEII) Health Sciences Centre in Halifax, Nova Scotia. Plastic surgeons will be asked to participate and enroll their breast reconstruction patients, who will undergo a type of abdominoplasty as part of their reconstruction procedure.
Patients will undergo a de novo abdominoplasty procedure as part of a reconstructive breast surgery. Two weeks post-operatively, one side of the patient's abdominoplasty incision will be randomized to receive the silicone tape and the remaining half will be left to heal without any dressing application, which is the current standard at the investigators institution. Each patient will act as their own control. 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.
It is not possible to mask patients, as they will be responsible for ongoing application of the silicone tape. However, the staff surgeon will be masked. Patients will present to their first post-op visit at two weeks. After examination by the staff surgeon, the patient will be seen by the research coordinator who will provide the patient with their randomization treatment assignment. To ensure ongoing masking, at subsequent follow-up visits, 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.
Patients will then follow up for scar assessment at 6 weeks, 3 months, 6 months and 12 months. Unless otherwise required, scar assessments will then be performed at each visit by both the patient and the surgeon using validated objective and subjective scar measures. Patients will also meet with the research coordinator at each follow up visit, to address any questions or concerns about the study and treatment.
The Patient and Observer Scar Assessment Scale (PSAS \& OSAS) system will be used to measure scar appearance. The PSAS and OSAS are tools 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 (Appendix A). 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. Secondary outcomes will include the sum of the components of the PSAS score and the overall scores out of 10 for both the PSAS and OSAS from the patient and masked surgeon.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
DOUBLE
Study Groups
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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.
Silicone tape
Medical grade tape with silicone adhesive
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.
No interventions assigned to this group
Interventions
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Silicone tape
Medical grade tape with silicone adhesive
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Nova Scotia Health Authority
OTHER
Responsible Party
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Jason Williams
Principal Investigation
Principal Investigators
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Jason G Williams, MD
Role: PRINCIPAL_INVESTIGATOR
Nova Scotia Health Authority
Locations
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Halifax Infirmary
Halifax, Nova Scotia, Canada
Countries
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Central Contacts
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Facility Contacts
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Jason Williams
Role: primary
References
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Longaker MT, Rohrich RJ, Greenberg L, Furnas H, Wald R, Bansal V, Seify H, Tran A, Weston J, Korman JM, Chan R, Kaufman D, Dev VR, Mele JA, Januszyk M, Cowley C, McLaughlin P, Beasley B, Gurtner GC. A randomized controlled trial of the embrace advanced scar therapy device to reduce incisional scar formation. Plast Reconstr Surg. 2014 Sep;134(3):536-546. doi: 10.1097/PRS.0000000000000417.
Bleasdale B, Finnegan S, Murray K, Kelly S, Percival SL. The Use of Silicone Adhesives for Scar Reduction. Adv Wound Care (New Rochelle). 2015 Jul 1;4(7):422-430. doi: 10.1089/wound.2015.0625.
Hsu KC, Luan CW, Tsai YW. Review of Silicone Gel Sheeting and Silicone Gel for the Prevention of Hypertrophic Scars and Keloids. Wounds. 2017 May;29(5):154-158.
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Kappel S, Kleinerman R, King TH, Sivamani R, Taylor S, Nguyen U, Eisen DB. Does wound eversion improve cosmetic outcome?: Results of a randomized, split-scar, comparative trial. J Am Acad Dermatol. 2015 Apr;72(4):668-73. doi: 10.1016/j.jaad.2014.11.032. Epub 2015 Jan 23.
Joo JS, Zhuang AR, Tchanque-Fossuo C, Tartar D, Armstrong AW, King TH, Sivamani RK, Eisen DB. Dermal suture only versus layered closure: A randomized, split wound comparative effectiveness trial. J Am Acad Dermatol. 2019 Dec;81(6):1346-1352. doi: 10.1016/j.jaad.2019.08.040. Epub 2019 Aug 21.
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Other Identifiers
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1025794
Identifier Type: -
Identifier Source: org_study_id
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