A Randomized Split Scar Study of Suture Safe Treatment of Surgical Wounds to Minimize Scaring
NCT ID: NCT02620475
Last Updated: 2015-12-03
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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UNKNOWN
NA
40 participants
INTERVENTIONAL
2016-01-31
2017-09-30
Brief Summary
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Detailed Description
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A full tummy tuck requires a horizontally-oriented incision in the area between the pubic hairline and belly button. The shape and length of the incision will be determined by the amount of excess skin. The excess skin is trimmed and the remaining skin is sutured together. A natural part of the healing process includes the body producing a fluid. The body is also able to reabsorb some fluid, but in the beginning there is more than the body can handle. Drains are inserted for one week post-operative to help remove that fluid. The usual standard of wound treatment to prevent scarring is to cover the incision with a self adhesive gauze type dressing (Mepore) covered by paper tape. The tape will be replaced at one-week post-operative and will be removed at two-weeks post-operative when the incision has fully healed. At this point the tape will then be replaced with a silicone strip for three additional months. In addition to the dressings the patient wearing a pressure garment for 1 month post-operative.
Patients who choose to be in the study, will have one half of the incision treated with the standard of care (explained in the previous paragraph) and the other side will be treated with SutureSafe dressings. Based on the Canadian medical device classification system, SutureSafe bandages are considered a class I device (which is the lowest risk category). The same process of wound care will be followed as outlined above, half of the incision will be treated with Mepore and paper tape, the other half of the incision will be treated with self-adhesive SutureSafe dressings. Both sides of the incisions will be replaced at one-week post-operative and will be removed at two-weeks post-operative when the incision has fully healed. At this point the tape will be replaced with a silicone strip and the SutureSafe bandages will be reapplied for three additional months.
The scar will be assessed at 3 months, 6 months and 1 year post-operative by observer Baillie Redfern. The clinical assessment of the scar will be performed using the Vancouver Scar Score criteria.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
SINGLE
Study Groups
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Gold standard of care
The usual gold standard of wound treatment to prevent scarring is to cover the incision with a self adhesive gauze type dressing (Mepore) covered by paper tape.
SutureSafe
SutureSafe dressing are designed to apply a constant gentle inward pressure on the incision to reduce separating tension on newly formed incisions, stabilizing the healing environment.
SutureSafe dressings
SutureSafe dressing are designed to apply a constant gentle inward pressure on the incision to reduce separating tension on newly formed incisions, stabilizing the healing environment.
SutureSafe
SutureSafe dressing are designed to apply a constant gentle inward pressure on the incision to reduce separating tension on newly formed incisions, stabilizing the healing environment.
Interventions
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SutureSafe
SutureSafe dressing are designed to apply a constant gentle inward pressure on the incision to reduce separating tension on newly formed incisions, stabilizing the healing environment.
Eligibility Criteria
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Inclusion Criteria
* Have undergone an abdominoplasty procedure by Dr. Nick Carr
* Have fitzpatrick skin type IV-VI
* Be willing and able to return for all study follow-up procedures
* Have not participated in any other investigational or invasive clinical trial within the last 30 days, and will not participate in any other investigational or invasive clinical trial during this study; and
* Have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the Research Ethics Board.
Exclusion Criteria
* Less than 18 years of ageCo-morbidity that reduces life expectancy to less than 12 months
* Cannot use any other methods (i.e. parmaceuditcal, natural, homeopathic) medications or devices for scar treatment.
* In the opinion of the Investigator, any medical condition that makes the subject unsuitable for inclusion in the study
18 Years
ALL
Yes
Sponsors
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University of British Columbia
OTHER
Responsible Party
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Principal Investigators
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Nick Carr, B.Sc. MD
Role: PRINCIPAL_INVESTIGATOR
The University of British Columbia
Baillie L Redfern, B.Sc., M.Sc
Role: STUDY_DIRECTOR
The University of British Columbia
Locations
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Skin Works
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H15-02683
Identifier Type: -
Identifier Source: org_study_id