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Silicone Taping for Abdominal Scars
N/A
Recruiting
Led By Jason G Williams, MD
Research Sponsored by Nova Scotia Health Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
undergoing de novo abdominoplasty procedures as part of their breast reconstruction
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month follow up
Awards & highlights
Study Summary
This trial will compare silicone tape to the current standard (no dressing) to see if it improves scar appearance after surgery.
Who is the study for?
This trial is for individuals getting new abdominoplasty as part of breast reconstruction. It's not suitable for those with scleroderma, open wounds or infections at the surgery site, inability to care for incisions, current smokers, steroid users, or a history of collagen disease, connective tissue disorders (like psoriasis or lupus), or silicone adhesive allergies.Check my eligibility
What is being tested?
The study tests if silicone tape can improve the appearance of scars after abdominoplasty compared to no dressing. Participants will have silicone tape applied to half their surgical scar two weeks post-operation and will be monitored over time to assess scar healing.See study design
What are the potential side effects?
Potential side effects may include skin irritation or allergic reactions specific to those sensitive to adhesives or silicone. However, since it's a non-invasive treatment, severe side effects are unlikely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having a tummy tuck as part of my breast reconstruction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 month follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month follow up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Silicone tapeExperimental Treatment1 Intervention
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.
Group II: No dressingActive Control1 Intervention
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.
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Who is running the clinical trial?
Nova Scotia Health AuthorityLead Sponsor
258 Previous Clinical Trials
83,822 Total Patients Enrolled
2 Trials studying Scarring
116 Patients Enrolled for Scarring
Jason G Williams, MDPrincipal InvestigatorNova Scotia Health Authority
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of certain autoimmune diseases such as lupus, psoriasis, or connective tissue disorders.I cannot take care of my surgical wounds by myself.I have scleroderma.I am having a tummy tuck as part of my breast reconstruction.You currently smoke cigarettes.I am currently taking steroids.I have signs of wound reopening or infection that required changes to my wound care.You have had a bad reaction to adhesives or are allergic to silicone.
Research Study Groups:
This trial has the following groups:- Group 1: Silicone tape
- Group 2: No dressing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the criteria to be eligible for this clinical experiment?
"Those who seek to join this experiment must meet two qualifications: they need to have scarring and be between 18-65 years old. The team is attempting to enroll 32 participants in total."
Answered by AI
Do you accept participants over 50 years old in this experiment?
"Patients between 18 and 65 years old are the only acceptable candidates for this clinical trial. However, there are 10 trials available to those below eighteen and 47 studies open to seniors above sixty-five."
Answered by AI
How many participants are being granted access to this research?
"Affirmative. According to the records on clinicaltrials.gov, this research study is actively seeking participants; it first appeared online in November of 2020 and was recently modified on July 19th 2022. The investigation requires 32 patients from one location for enrolment."
Answered by AI
Is this experiment still recruiting participants?
"According to clinicaltrials.gov, this research is presently engaging in participant recruitment. The trial was first publicized on November 16th 2020 and was last updated July 19th 2022."
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