ScarsNCT02620475
A Randomized Split Scar Study of Suture Safe Treatment of Surgical Wounds to Minimize Scaring
A study testing SutureSafe in people with Scars, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the effect SutureSafe dressings have on reducing scarring from an incision following an elective abdominoplasty (tummy tuck) procedure. The scar will be evaluated using subjective clinical assessment criteria. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scars
- What is being tested?
- SutureSafe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old and older
- 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.
Who cannot join
- Are unable to meet the treatment and follow up protocol requirements.
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Skin Works
Vancouver, British Columbia, V6N 3E6
Nick Carr, B.Sc. MD, (604) 737-7100, drcarr@skinworks.ca
Baillie Redfern, B.Sc. M.Sc, 604-362-2501, baillie.redfern@gmail.com
About this study
Official title: A Randomized Split Scar Study of Suture Safe (South Medic) Treatment of Surgical Wounds to Minimize Scaring
The purpose of this study is to evaluate the effect SutureSafe dressings have on reducing scarring from an incision following an elective abdominoplasty (tummy tuck) procedure. The scar will be evaluated using subjective clinical assessment criteria. Each participant in the study will serve as a control and experiential study, since have of the incision will be treated with the gold standard of care and the other half with SutureSafe dressings.
Read the detailed description
Patients of Dr. Nick Carr's who have elected to undergo an abdominoplasty (tummy tuck) procedure and have a fitzpatrick skin type of IV-VI will be offered participation in the study.
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
- Scars
- Being tested
- SutureSafe
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SutureSafeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Gold standard of care | Active comparator | 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. Receives: Device: SutureSafe |
| SutureSafe dressings | Experimental | 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. Receives: Device: SutureSafe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change between usual standard of care and experimental dressings at 3 months, 6 months and 1 year, assessed using the Vancouver Scar Score
Measured: 3 months, 6 months and 1 year post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nick Carr, B.Sc. MD, Principal investigator, The University of British ColumbiaBaillie L Redfern, B.Sc., M.Sc, Study director, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620475
- Sponsor's protocol ID
- H15-02683
- Status last verified
- Nov 2015
- First submitted
- 23 Nov 2015
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Split Scar Study of Suture Safe (South Medic) Treatment of Surgical Wounds to Minimize Scaring
- ClinicalTrials.gov ID
- NCT02620475
- Acronym / sponsor ID
- H15-02683
- Conditions
- Scars
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 3 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect SutureSafe dressings have on reducing scarring from an incision following an elective abdominoplasty (tummy tuck) procedure. The scar will be evaluated using subjective clinical assessment criteria. Each participant in the study will serve as a control and experiential study, since have of the incision will be treated with the gold standard of care and the other half with SutureSafe dressings.
Detailed description
Patients of Dr. Nick Carr's who have elected to undergo an abdominoplasty (tummy tuck) procedure and have a fitzpatrick skin type of IV-VI will be offered participation in the study.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gold standard of care | Active comparator | Device: SutureSafeThe 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 dressings | Experimental | Device: SutureSafeSutureSafe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years old and older
- 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
Key exclusion criteria (4 listed)
- Are unable to meet the treatment and follow up protocol requirements.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SutureSafeSutureSafe 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. | Device | Gold standard of care, SutureSafe dressings |
Primary outcome
Change between usual standard of care and experimental dressings at 3 months, 6 months and 1 year, assessed using the Vancouver Scar Score
Time frame: 3 months, 6 months and 1 year post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick Carr, B.Sc. MD principal investigator
The University of British Columbia
Baillie L Redfern, B.Sc., M.Sc study director
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SutureSafe in people with Scars, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baillie L Redfern, B.Sc., M.Sc (6043622501, baillie.redfern@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change between usual standard of care and experimental dressings at 3 months, 6 months and 1 year, assessed using the Vancouver Scar Score (time frame: 3 months, 6 months and 1 year post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.