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Silicone Taping for the Improvement of Abdominal Donor Site Scars

Primary Purpose

Hypertrophic Scar, Scar

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Silicone tape
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertrophic Scar focused on measuring Silicone, Scar, Abdominoplasty, Breast Reconstruction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Halifax InfirmaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Silicone tape

No dressing

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
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. A lower score in each component indicates an improved scar.
Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
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. A lower score in each component indicates an improved scar.
Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
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. A lower score in each component indicates an improved scar.
Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
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. A lower score in each component indicates an improved scar.

Full Information

First Posted
August 5, 2020
Last Updated
August 28, 2023
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT04506255
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2020 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Scar, Scar
Keywords
Silicone, Scar, Abdominoplasty, Breast Reconstruction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
Care ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Silicone tape
Arm Type
Experimental
Arm Description
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.
Arm Title
No dressing
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Silicone tape
Intervention Description
Medical grade tape with silicone adhesive
Primary Outcome Measure Information:
Title
Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
Description
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.
Time Frame
6 week follow up, 3 months, 6 months and 12 months.
Title
Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
Description
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.
Time Frame
3 month follow up
Title
Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
Description
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.
Time Frame
6 month follow up
Title
Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
Description
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.
Time Frame
12 month follow up
Secondary Outcome Measure Information:
Title
Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
Description
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. A lower score in each component indicates an improved scar.
Time Frame
6 week follow up
Title
Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
Description
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. A lower score in each component indicates an improved scar.
Time Frame
3 month follow up
Title
Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
Description
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. A lower score in each component indicates an improved scar.
Time Frame
6 month follow up
Title
Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
Description
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. A lower score in each component indicates an improved scar.
Time Frame
12 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason G Williams, MD
Phone
902-473-6315
Email
Jason.Williams@nshealth.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Burke, MD
Phone
902-694-8080
Email
Emily.Burke@dal.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason G Williams, MD
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Halifax Infirmary
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Williams
Phone
902-473-6315

12. IPD Sharing Statement

Plan to Share IPD
No
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Silicone Taping for the Improvement of Abdominal Donor Site Scars

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