Clinical trial NCT04506255: Silicone Taping for the Improvement of Abdominal Donor Site Scars
Official title: Silicone Taping for the Improvement of Abdominal Donor Site Scars Following Autologous Breast Reconstruction; A Randomized, Prospective Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertrophic Scar
Scar
Keywords: Silicone
Scar
Abdominoplasty
Breast Reconstruction
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: 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. Incisions from 32 adult subjects will act as their own control and will be randomized to have silicone tape applied to one half of their abdominoplasty incision and control treatment using the current standard of care at the investigators institution to the other half, which is no dressing after the initial two week post-op period. A participant size of 32 leaves room in case of participant loss to follow-up, ensuring data will be available for the required sample size of 28 (see statistical analysis section below). A random number sequence generator will be used to randomize which half of the patient's wound will receive the treatment.

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.

Eligibility criteria: 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 outcomes:
measure: Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
timeFrame: 6 week follow up, 3 months, 6 months and 12 months.
measure: Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
timeFrame: 3 month follow up
measure: Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
timeFrame: 6 month follow up
measure: Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
timeFrame: 12 month follow up
Secondary outcomes:
measure: Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
timeFrame: 6 week follow up
measure: Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
timeFrame: 3 month follow up
measure: Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
timeFrame: 6 month follow up
measure: Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
timeFrame: 12 month follow up
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Halifax Infirmary
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Jason G Williams, MD
role: PRINCIPAL_INVESTIGATOR
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