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| ID | Type | Description | Link |
|---|---|---|---|
| 00016580 | Other Grant/Funding Number | Armed Forces Institute of Regenerative Medicine |
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| Name | Class |
|---|---|
| U.S. Army Medical Research and Development Command | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| embrace Dressing | Experimental | Investigational Dressing |
|
| Standard of Care | No Intervention | Standard of care comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| embrace device | Device | Adhesive bandage/dressing intended to minimize scar formation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodney J Rohrich, MD, FACS | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atherton Plastic Surgery | Atherton | California | 94027 | United States | ||
| Vipul R. Dev MD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40701926 | Derived | 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. | |
| 24804638 | Derived | 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. |
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Procedures were performed by 12 surgeons at 12 surgery centers between June 2011 and May of 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Half of the abdominoplasty incision was treated with the embrace device. Half of the abdominoplasty incision was treated according to the investigator's standard of care. Participant served as his own control. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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. | 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. | 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. | 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. | 6 Months |
| Patient Satisfaction - Recommend | Subjects were were asked to rate how likely they were to recommend embrace treatment to a friend. | 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. | 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. | 12 Months |
| Patient Satisfaction - Recommend | Subjects were were asked to rate how likely they were to recommend embrace treatment to a friend. | 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. | 12 Months |
| Bakersfield |
| California |
| 93308 |
| United States |
| Elite MD | Danville | California | 94526 | United States |
| Kaufman and Clark Plastic Surgery | Folsom | California | 95630 | United States |
| The Aesthetic Institute | Fullerton | California | 92835 | United States |
| The Korman Group | Mountain View | California | 94040 | United States |
| Newport Plastic Surgery | Newport Beach | California | 92660 | United States |
| Lauren Greenberg, MD | Palo Alto | California | 94304 | United States |
| Plastic Surgery Associates of Santa Rose | Santa Rosa | California | 95409 | United States |
| Joseph Mele, MD | Walnut Creek | California | 94598 | United States |
| Academy of Clinical Research | Arlington | Texas | 76011 | United States |
| The University of Texas Southwestern Medical Center - Dept. of Plastic Surgery | Dallas | Texas | 75390-9132 | United States |
| US Army Institute of Surgical Research | Fort Sam Houston | Texas | 78234 | United States |
| 6 Months |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
After meeting all eligibility criteria, 67 patients were enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Half of the abdominoplasty incision was treated with the embrace device. Half of the abdominoplasty incision was treated according to the investigator's standard of care. Participant served as his own control. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Per protocol, all eligible patients who did not exit the study prematurely. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| ||||||||||||||||||||||||||||
| Primary | 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. | Per protocol, all eligible patients who did not exit the study prematurely. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | Per protocol, all eligible patients who did not exit the study prematurely. | Posted | Mean | Standard Deviation | score on a scale | 6 Months |
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| Secondary | 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. | Per protocol, all eligible patients who did not exit the study prematurely. | Posted | Mean | Standard Deviation | score on a scale | 12 Months |
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| Secondary | 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. | Per protocol, all eligible patients who did not exit the study prematurely. | Posted | Mean | Standard Deviation | score on a scale | 6 Months |
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| Secondary | 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. | Per protocol, all eligible patients who did not exit the study prematurely. | Posted | Mean | Standard Deviation | score on a scale | 12 Months |
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| Secondary | 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. | Per protocol, all eligible patients who did not exit the study prematurely. | Posted | Count of Participants | Participants | 6 Months |
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| Secondary | Patient Satisfaction - Recommend | Subjects were were asked to rate how likely they were to recommend embrace treatment to a friend. | Per protocol, all eligible patients who did not exit the study prematurely. | Posted | Count of Participants | Participants | 6 Months |
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| Secondary | 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. | Per protocol, all eligible patients who did not exit the study prematurely. | Posted | Count of Participants | Participants | 6 Months |
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| Secondary | 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. | Per protocol, all eligible patients who did not exit the study prematurely. | Posted | Count of Participants | Participants | 12 Months |
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| Secondary | Patient Satisfaction - Recommend | Subjects were were asked to rate how likely they were to recommend embrace treatment to a friend. | Per protocol, all eligible patients who did not exit the study prematurely. | Posted | Count of Participants | Participants | 12 Months |
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| Secondary | 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. | Per protocol, all eligible patients who did not exit the study prematurely. | Posted | Count of Participants | Participants | 12 Months |
|
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12 Months
Adverse Events were reported via phone call or in person at weekly site visits for Neodyne dressing applications. Data was collected by investigators on Adverse Event Clinical Report Forms for each participant. After initial 12 weeks of application visits, data was collected at 6 month and 12 month (optional) intervals. Adverse Events data were only collected for the interventional treatment arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Arm | Half of the abdominoplasty incision was treated with the embrace device. | 0 | 67 | 0 | 67 | 40 | 67 |
| EG001 | All Study Participants | Half of the abdominoplasty incision was treated with the embrace device. Half of the abdominoplasty incision was treated according to the investigator's standard of care. Participant served as his own control. | 0 | 67 | 0 | 67 | 40 | 67 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Maceration | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin Irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director of R&D | Neodyne Biosciences | 510-456-4128 | 128 | jjackson@neodynebio.com |
| ID | Term |
|---|---|
| D006984 | Hypertrophy |
| D002921 | Cicatrix |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D014947 | Wounds and Injuries |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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