HypertrophicREFINENCT01399099

A Study of a Novel Silicone Dressing to Minimize Scar Formation

A study testing embrace device in people with Hypertrophic, run by Neodyne Biosciences, Inc. at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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: 67 participants
Where: 13 sitesUnited States
Study dates: Jun 2011to Mar 2013
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

Subjects who have undergone a de novo abdominoplasty.
Appearance of subject's incision is aesthetically similar across length of incision.

Who cannot join

Subjects with a history of collagen vascular disease, cutis laxica, connective tissue disease, psoriasis, or lupus.
Subjects diagnosed with scleroderma.
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.
Subjects with a body mass index (BMI) > 30.

Show all 9Show fewer

Subjects with a weight loss of greater than or equal to 100 lbs within 6 months from date of abdominoplasty.
Subjects who currently smoke.
Subjects taking steroid therapy.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Academy of Clinical Research
Arlington, Texas, 76011
Atherton Plastic Surgery
Atherton, California, 94027
Vipul R. Dev MD
Bakersfield, California, 93308
The University of Texas Southwestern Medical Center - Dept. of Plastic Surgery
Dallas, Texas, 75390-9132
Elite MD
Danville, California, 94526
Kaufman and Clark Plastic Surgery
Folsom, California, 95630
US Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234
The Aesthetic Institute
Fullerton, California, 92835
The Korman Group
Mountain View, California, 94040
Newport Plastic Surgery
Newport Beach, California, 92660
Lauren Greenberg, MD
Palo Alto, California, 94304
Plastic Surgery Associates of Santa Rose
Santa Rosa, California, 95409
Joseph Mele, MD
Walnut Creek, California, 94598

Other trials in United States

About this study

Official title: Scar Prevention and the Clinical Effectiveness of a Novel Mechanomodulating Polymer

Read the detailed description

It is proposed to study a dressing designed to reduce scarring in post-incision skin tissue. It is expected that by managing the incision site during the healing phase, scar formation may be minimized.

Conditions: Hypertrophic
Being tested: embrace device
Keywords: scar, incision, wound healing, scarring, post-surgical
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 Device, embrace dressing, Neodyne Dressing
Adhesive bandage/dressing intended to minimize scar formation.

Study groups in NCT01399099
Study group	Role	What they receive
embrace Dressing	Experimental	Investigational Dressing Receives: Device: embrace device
Standard of Care	No intervention	Standard of care comparator

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: 12 months
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 (10)

Patient and Observer Scar Assessment Scale (POSAS) - Patient Results
The Patient and Observer Scar Assessment Scale consists of two numeric scales: the Patient Scar Assessment Scale (patient scale) and the Observer Scar Assessment Scale (observer scale). The patient and observer scales have to be completed by the patient and the observer, respectively [1]. The POSAS criteria evaluated by the patients in this study were pain, itching, color, stiffness, thickness, irregularity, and overall opinion. The Patient and Observer Scar Assessment Scale (POSAS) ranges from 1 to 10 with 10 being the worst imaginable or most different.
[1] Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56. PMID: 15253184.
Measured: 6 Months
Patient and Observer Scar Assessment Scale (POSAS) - Patient Results
The Patient and Observer Scar Assessment Scale consists of two numeric scales: the Patient Scar Assessment Scale (patient scale) and the Observer Scar Assessment Scale (observer scale). The patient and observer scales have to be completed by the patient and the observer, respectively [1]. The POSAS criteria evaluated by the patients in this study were pain, itching, color, stiffness, thickness, irregularity, and overall opinion.
[1] Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56. PMID: 15253184.
Measured: 12 Months
Patient and Observer Scar Assessment Scale (POSAS) - Observer Results
The Patient and Observer Scar Assessment Scale consists of two numeric scales: the Patient Scar Assessment Scale (patient scale) and the Observer Scar Assessment Scale (observer scale). The patient and observer scales have to be completed by the patient and the observer, respectively [1]. The POSAS criteria evaluated by the observers in this study were vascularity, pigmentation, thickness, relief, pliability, surface area, and an overall opinion.
[1] Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56. PMID: 15253184.
Measured: 6 Months
Patient and Observer Scar Assessment Scale (POSAS) - Observer Results
The Patient and Observer Scar Assessment Scale consists of two numeric scales: the Patient Scar Assessment Scale (patient scale) and the Observer Scar Assessment Scale (observer scale). The patient and observer scales have to be completed by the patient and the observer, respectively [1]. The POSAS criteria evaluated by the observers in this study were vascularity, pigmentation, thickness, relief, pliability, surface area, and an overall opinion.
[1] Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56. PMID: 15253184.
Measured: 12 Months
Patient Satisfaction - Scar Minimization
Subjects were were asked to compare the embrace-treated side with the control-treated side with regards to their satisfaction with the scar minimization on their incision.
Measured: 6 Months
Patient Satisfaction - Recommend
Subjects were were asked to rate how likely they were to recommend embrace treatment to a friend.
Measured: 6 Months
Patient Satisfaction - Use Again
Subjects were asked if they were to have another procedure that would leave a scar how likely would they be to use embrace treatment again.
Measured: 6 Months
Patient Satisfaction - Scar Minimization
Subjects were were asked to compare the embrace-treated side with the control-treated side with regards to their satisfaction with the scar minimization on their incision.
Measured: 12 Months
Patient Satisfaction - Recommend
Subjects were were asked to rate how likely they were to recommend embrace treatment to a friend.
Measured: 12 Months
Patient Satisfaction - Use Again
Subjects were asked if they were to have another procedure that would leave a scar how likely would they be to use embrace treatment again.
Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011Mar 2013

First posted21 Jul 2011 (estimated)
Study startJun 2011
Primary completionSep 2012
Study completionMar 2013

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.
Publications (2)Papers the sponsor has linked to this study.
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: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01399099
Sponsor's protocol ID: CA003
Other IDs: 00016580
Acronym: REFINE
Status last verified: Nov 2024
First submitted: 27 Jun 2011
Last updated: 19 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kness-Knezinskis E, Sheckley M, Hostler AC, Mora Pinos MG, Chen K, Gurtner GC. Translational approaches manipulating mechanobiology to promote scarless healing in humans. J Plast Reconstr Aesthet Surg. 2026 Jan;112:25-33. doi: 10.1016/j.bjps.2025.06.041. Epub 2025 Jul 8.
PubMed 40701926
Longaker MT, Rohrich RJ, Greenberg L, Furnas H, Wald R, Bansal V, Seify H, Tran A, Weston J, Korman JM, Chan R, Kaufman D, Dev VR, Mele JA, Januszyk M, Cowley C, McLaughlin P, Beasley B, Gurtner GC. A randomized controlled trial of the embrace advanced scar therapy device to reduce incisional scar formation. Plast Reconstr Surg. 2014 Sep;134(3):536-546. doi: 10.1097/PRS.0000000000000417.
PubMed 24804638

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Scar Prevention and the Clinical Effectiveness of a Novel Mechanomodulating Polymer
ClinicalTrials.gov ID: NCT01399099
Acronym / sponsor ID: REFINE / CA003
Conditions: Hypertrophic
Keywords: scar, incision, wound healing, scarring, post-surgical
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Neodyne Biosciences, Inc.Industry (pharma, biotech, devices)
Collaborators: U.S. Army Medical Research and Development Command
Study start: Jun 2011
Primary completion: Sep 2012 (actual)
Study completion: Mar 2013 (actual)
First posted: 21 Jul 2011 (estimated)
Results: Posted 25 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
embrace Dressing	Experimental	Device: embrace deviceInvestigational Dressing
Standard of Care	No intervention	–Standard of care comparator

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subjects who have undergone a de novo abdominoplasty.
Appearance of subject's incision is aesthetically similar across length of incision.

Key exclusion criteria (9 listed)

Subjects with a history of collagen vascular disease, cutis laxica, connective tissue disease, psoriasis, or lupus.
Subjects diagnosed with scleroderma.
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.

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 Device, embrace dressing, Neodyne DressingAdhesive bandage/dressing intended to minimize scar formation.	Device	embrace Dressing

Primary outcome

Visual Analogue Scale (VAS)
Time frame: 12 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.
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.

10 secondary outcomes

Patient and Observer Scar Assessment Scale (POSAS) - Patient Results
Time frame: 6 Months
Patient and Observer Scar Assessment Scale (POSAS) - Patient Results
Time frame: 12 Months
Patient and Observer Scar Assessment Scale (POSAS) - Observer Results
Time frame: 6 Months
Patient and Observer Scar Assessment Scale (POSAS) - Observer Results
Time frame: 12 Months
Patient Satisfaction - Scar Minimization
Time frame: 6 Months
Patient Satisfaction - Recommend
Time frame: 6 Months
Patient Satisfaction - Use Again
Time frame: 6 Months
Patient Satisfaction - Scar Minimization
Time frame: 12 Months
Patient Satisfaction - Recommend
Time frame: 12 Months
Patient Satisfaction - Use Again
Time frame: 12 Months

Results and safety

Results posted to the registry on 25 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	67	33

Primary outcome: Visual Analogue Scale (VAS)

Time frame: 12 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Treated Side n = 33	Control Side n = 33
Value	2.90 (1.36)	3.29 (1.55)

Population analysed: Per protocol, all eligible patients who did not exit the study prematurely.

Primary outcome: Visual Analogue Scale (VAS)

Time frame: 6 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Treated Side n = 47	Control Side n = 47
Value	3.18 (1.71)	3.85 (1.77)

Population analysed: Per protocol, all eligible patients who did not exit the study prematurely.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 Months. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Arm	0 of 67 (0%)	40 of 67 (59.7%)	0 of 67
All Study Participants	0 of 67 (0%)	40 of 67 (59.7%)	0 of 67

Limitations and caveats (from the sponsor): * The Neodyne Dressing is referred to as the embrace device. * Grant/Funding source: Armed Forces Institute of Regenerative Medicine is funded by US Army Medical Research and Materiel Command (our collaborator) http://www.afirm.mil/

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40701926Kness-Knezinskis E, Sheckley M, Hostler AC, Mora Pinos MG, Chen K, Gurtner GC. Translational approaches manipulating mechanobiology to promote scarless healing in humans. J Plast Reconstr Aesthet Surg. 2026 Jan;112:25-33. doi: 10.1016/j.bjps.2025.06.041. Epub 2025 Jul 8.
Derived from this study: PubMed 24804638Longaker MT, Rohrich RJ, Greenberg L, Furnas H, Wald R, Bansal V, Seify H, Tran A, Weston J, Korman JM, Chan R, Kaufman D, Dev VR, Mele JA, Januszyk M, Cowley C, McLaughlin P, Beasley B, Gurtner GC. A randomized controlled trial of the embrace advanced scar therapy device to reduce incisional scar formation. Plast Reconstr Surg. 2014 Sep;134(3):536-546. doi: 10.1097/PRS.0000000000000417.

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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.

Rodney J Rohrich, MD, FACS principal investigator

University of Texas Southwestern Medical Center

13 sites 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 13 sites 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 2 inclusion and 9 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 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites 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 25 Dec 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: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01399099, which also lists 2 linked publications.

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 19 Nov 2024.