HypertrophicIMPROVENCT01430130
Investigation of a Novel Silicone Dressing to Maximize the Outcomes of Scar Revision Procedures (IMPROVE)
A study testing embrace device in people with Hypertrophic, run by Neodyne Biosciences, Inc. at 1 site in United States.
Trial summary
Neodyne has developed an investigational dressing for post-operative incision care. Neodyne is conducting this research to study whether the investigational dressing, called the Neodyne Dressing, can minimize scar formation in a simple manner. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertrophic
- What is being tested?
- embrace device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Nov 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The scar to be revised is:
- at least 12 months old
- linear and suitable for revision by excision and direct closure
- appropriate size and location for Neodyne Dressing
- The subject:
- age > 18 and < 65 years old
Who cannot join
- Subjects with a skin disorder that is chronic or currently active.
- Subjects who are involved in ongoing litigation in connection with the scar to be revised.
- Subjects with a history of collagen vascular disease
- Subjects diagnosed with scleroderma
- Subject who currently smokes
- Subjects with known adverse reactions to steri-strip tapes, medical tapes, or adhesives
- Subjects with oozing, dehiscence, non-closed/healed incisions at time of first application.
- Subjects with inability to maintain adequate care of incision.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of a Novel Mechanomodulating Polymer to Maximize the Outcomes of Scar Revision Procedures
Neodyne has developed an investigational dressing for post-operative incision care. Neodyne is conducting this research to study whether the investigational dressing, called the Neodyne Dressing, can minimize scar formation in a simple manner.
Read the detailed description
It is proposed to study a dressing designed to reduce the appearance of scars after scar revision surgery. It is expected that by managing the incision site after primary closure but during the longer term healing phase, scar formation may be minimized.
- Conditions
- Hypertrophic
- Being tested
- embrace device
- Keywords
- scar, incision, wound healing, scarring, scar revision
- Medical subject headings
- Hypertrophy, Cicatrix, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
embrace deviceDevice
Also called Neodyne dressing
Adhesive bandage/dressing intended to minimize scar formation.
| Study group | Role | What they receive |
|---|---|---|
| All Study Participants | Experimental | Half of the revised incision was treated with the embrace device. Half of the revised incision was treated according to the Investigator's standard of care. Participant served as his/her own control. Receives: Device: embrace device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
Visual Analogue Scale Scar Score (VAS Scar Score) was defined and validated by Duncan et al 2006[1]. This scale consists of a 10cm line representing scar quality, with 0 representing normal skin and 10 indicating a poor scar. The assessor places a mark along the line to represent the appearance of the scar. This mark is translated into a score by measuring its position on the 10cm line to one decimal place. The independent panel used this to scale the primary outcome.
[1] Duncan J, Bond J, Mason T, Ludlow A, Cridland P, O'Kane S and Ferguson M. Visual Analogue Scale Scoring and Ranking: A Suitable and Sensitive Method for Assessing Scar Quality? Plast. Reconstr. Surg. 118: 909, 2006.
Measured: 6 months
Secondary outcomes (4)
Subject and Investigator Satisfaction With the Aesthetic Results
Measured: Up to 12 months
Ease of Use
Measured: Up to 12 months
Comfort Level Related to Study Device Application, Wear and Removal
Measured: Up to 12 weeks
Comparison of Scar Smoothness of Treated Side as Compared to the Control Side
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertrophicStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neodyne Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Weintraub, MD, Principal investigator, Duet Plastic SurgeryAngeline Lim, MD, Principal investigator, Duet Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430130
- Sponsor's protocol ID
- CA005
- Acronym
- IMPROVE
- Status last verified
- Nov 2014
- First submitted
- 6 Sep 2011
- Last updated
- 28 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of a Novel Mechanomodulating Polymer to Maximize the Outcomes of Scar Revision Procedures
- ClinicalTrials.gov ID
- NCT01430130
- Acronym / sponsor ID
- IMPROVE / CA005
- Conditions
- Hypertrophic
- Keywords
- scar, incision, wound healing, scarring, scar revision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Neodyne Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 7 Sep 2011 (estimated)
- Results
- Posted 28 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neodyne has developed an investigational dressing for post-operative incision care. Neodyne is conducting this research to study whether the investigational dressing, called the Neodyne Dressing, can minimize scar formation in a simple manner.
Detailed description
It is proposed to study a dressing designed to reduce the appearance of scars after scar revision surgery. It is expected that by managing the incision site after primary closure but during the longer term healing phase, scar formation may be minimized.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Study Participants | Experimental | Device: embrace deviceHalf of the revised incision was treated with the embrace device. Half of the revised incision was treated according to the Investigator's standard of care. Participant served as his/her own control. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The scar to be revised is:
- The subject:
Key exclusion criteria (8 listed)
- Subjects with a skin disorder that is chronic or currently active.
- Subjects who are involved in ongoing litigation in connection with the scar to be revised.
- Subjects with a history of collagen vascular disease
- Subjects diagnosed with scleroderma
- Subject who currently smokes
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 |
|---|---|---|
| embrace deviceAlso: Neodyne dressingAdhesive bandage/dressing intended to minimize scar formation. | Device | All Study Participants |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 6 months
Visual Analogue Scale Scar Score (VAS Scar Score) was defined and validated by Duncan et al 2006[1]. This scale consists of a 10cm line representing scar quality, with 0 representing normal skin and 10 indicating a poor scar. The assessor places a mark along the line to represent the appearance of the scar. This mark is translated into a score by measuring its position on the 10cm line to one decimal place. The independent panel used this to scale the primary outcome. [1] Duncan J, Bond J, Mason T, Ludlow A, Cridland P, O'Kane S and Ferguson M. Visual Analogue Scale Scoring and Ranking: A Suitable and Sensitive Method for Assessing Scar Quality? Plast. Reconstr. Surg. 118: 909, 2006.
4 secondary outcomes
Subject and Investigator Satisfaction With the Aesthetic Results
Time frame: Up to 12 months
Ease of Use
Time frame: Up to 12 months
Comfort Level Related to Study Device Application, Wear and Removal
Time frame: Up to 12 weeks
Comparison of Scar Smoothness of Treated Side as Compared to the Control Side
Time frame: Up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jennifer Weintraub, MD principal investigator
Duet Plastic Surgery
Angeline Lim, MD principal investigator
Duet Plastic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing embrace device in people with Hypertrophic, run by Neodyne Biosciences, Inc. at 1 site in United States.
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 8 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: finished, as of the sponsor's last update on 28 Nov 2014. 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 United States. 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?
Yes. Results are posted in the registry (first posted 28 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: 6 months). 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 28 Nov 2014.