Silicone Taping for the Improvement of Abdominal Donor Site Scars
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNova Scotia Health Authority
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
undergoing de novo abdominoplasty procedures as part of their breast reconstruction
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Silicone tape
DeviceMedical grade tape with silicone adhesive
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Silicone tapeExperimental treatment 1 intervention
Group B: No dressingNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
6 week follow up, 3 months, 6 months and 12 months.2
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.
Time frame
3 month follow up3
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.
Time frame
6 month follow up4
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.
Time frame
12 month follow upSecondary outcomes
1
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.
Time frame
6 week follow up2
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.
Time frame
3 month follow up3
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.
Time frame
6 month follow up4
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.
Time frame
12 month follow upSponsors and contacts
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Source ClinicalTrials.gov