Trial Outcomes & Findings for A Study of a Novel Silicone Dressing to Minimize Scar Formation (NCT NCT01399099)

NCT ID: NCT01399099

Last Updated: 2024-11-19

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 67 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2024-11-19

Participant Flow

Procedures were performed by 12 surgeons at 12 surgery centers between June 2011 and May of 2012.

Participant milestones

Measure	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.
Overall Study STARTED	67
Overall Study 6 Months	47
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	34

Reasons for withdrawal

Measure	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.
Overall Study Lost to Follow-up	14
Overall Study Physician Decision	1
Overall Study Protocol Violation	1
Overall Study Skin Irritation	13
Overall Study Infection	1
Overall Study Miscellaneous	4

Baseline Characteristics

A Study of a Novel Silicone Dressing to Minimize Scar Formation

Baseline characteristics by cohort

Measure	All Study Participants n=67 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	66 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants
Region of Enrollment United States	67 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

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

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.

Outcome measures

Measure	Treated Side n=33 Participants Half of the abdominoplasty incision was treated with the embrace device.	Control Side n=33 Participants Half of the abdominoplasty incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
Visual Analogue Scale (VAS)	2.90 score on a scale Standard Deviation 1.36	3.29 score on a scale Standard Deviation 1.55

PRIMARY outcome

Timeframe: 6 months

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

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.

Outcome measures

Measure	Treated Side n=47 Participants Half of the abdominoplasty incision was treated with the embrace device.	Control Side n=47 Participants Half of the abdominoplasty incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
Visual Analogue Scale (VAS)	3.18 score on a scale Standard Deviation 1.71	3.85 score on a scale Standard Deviation 1.77

SECONDARY outcome

Timeframe: 6 Months

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

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.

Outcome measures

Measure	Treated Side n=44 Participants Half of the abdominoplasty incision was treated with the embrace device.	Control Side n=44 Participants Half of the abdominoplasty incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
Patient and Observer Scar Assessment Scale (POSAS) - Patient Results Pain	1.05 score on a scale Standard Deviation 0.21	1.21 score on a scale Standard Deviation 0.80
Patient and Observer Scar Assessment Scale (POSAS) - Patient Results Itch	1.41 score on a scale Standard Deviation 1.24	1.52 score on a scale Standard Deviation 1.47
Patient and Observer Scar Assessment Scale (POSAS) - Patient Results Color	4.75 score on a scale Standard Deviation 2.37	5.21 score on a scale Standard Deviation 2.53
Patient and Observer Scar Assessment Scale (POSAS) - Patient Results Stiffness	2.91 score on a scale Standard Deviation 1.95	4.48 score on a scale Standard Deviation 2.60
Patient and Observer Scar Assessment Scale (POSAS) - Patient Results Thickness	3.34 score on a scale Standard Deviation 2.12	4.30 score on a scale Standard Deviation 2.30
Patient and Observer Scar Assessment Scale (POSAS) - Patient Results Irregularity	3.66 score on a scale Standard Deviation 2.38	4.61 score on a scale Standard Deviation 2.64
Patient and Observer Scar Assessment Scale (POSAS) - Patient Results Overall	3.70 score on a scale Standard Deviation 2.21	4.91 score on a scale Standard Deviation 2.75

SECONDARY outcome

Timeframe: 12 Months

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

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.

Outcome measures

Measure	Treated Side n=35 Participants Half of the abdominoplasty incision was treated with the embrace device.	Control Side n=35 Participants Half of the abdominoplasty incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
Patient and Observer Scar Assessment Scale (POSAS) - Patient Results Pain	1.00 score on a scale Standard Deviation 0.00	1.06 score on a scale Standard Deviation 0.24
Patient and Observer Scar Assessment Scale (POSAS) - Patient Results Itch	1.40 score on a scale Standard Deviation 1.24	1.29 score on a scale Standard Deviation 1.20
Patient and Observer Scar Assessment Scale (POSAS) - Patient Results Color	3.80 score on a scale Standard Deviation 2.21	4.31 score on a scale Standard Deviation 2.49
Patient and Observer Scar Assessment Scale (POSAS) - Patient Results Stiffness	2.63 score on a scale Standard Deviation 2.06	3.77 score on a scale Standard Deviation 2.43
Patient and Observer Scar Assessment Scale (POSAS) - Patient Results Thickness	2.86 score on a scale Standard Deviation 2.02	3.97 score on a scale Standard Deviation 2.48
Patient and Observer Scar Assessment Scale (POSAS) - Patient Results Irregularity	3.46 score on a scale Standard Deviation 2.19	4.29 score on a scale Standard Deviation 2.58
Patient and Observer Scar Assessment Scale (POSAS) - Patient Results Overall	3.66 score on a scale Standard Deviation 2.35	4.66 score on a scale Standard Deviation 2.80

SECONDARY outcome

Timeframe: 6 Months

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

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.

Outcome measures

Measure	Treated Side n=45 Participants Half of the abdominoplasty incision was treated with the embrace device.	Control Side n=45 Participants Half of the abdominoplasty incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
Patient and Observer Scar Assessment Scale (POSAS) - Observer Results Vascularity	2.07 score on a scale Standard Deviation 0.72	2.96 score on a scale Standard Deviation 1.46
Patient and Observer Scar Assessment Scale (POSAS) - Observer Results Pigmentation	2.16 score on a scale Standard Deviation 1.11	3.13 score on a scale Standard Deviation 1.58
Patient and Observer Scar Assessment Scale (POSAS) - Observer Results Thickness	3.07 score on a scale Standard Deviation 2.78	3.73 score on a scale Standard Deviation 2.19
Patient and Observer Scar Assessment Scale (POSAS) - Observer Results Relief	2.78 score on a scale Standard Deviation 1.52	3.62 score on a scale Standard Deviation 1.81
Patient and Observer Scar Assessment Scale (POSAS) - Observer Results Pliability	2.09 score on a scale Standard Deviation 1.00	2.98 score on a scale Standard Deviation 1.45
Patient and Observer Scar Assessment Scale (POSAS) - Observer Results Surface Area	3.07 score on a scale Standard Deviation 2.29	3.42 score on a scale Standard Deviation 1.76
Patient and Observer Scar Assessment Scale (POSAS) - Observer Results Overall Opinion	1.98 score on a scale Standard Deviation 0.62	3.02 score on a scale Standard Deviation 1.45

SECONDARY outcome

Timeframe: 12 Months

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

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.

Outcome measures

Measure	Treated Side n=36 Participants Half of the abdominoplasty incision was treated with the embrace device.	Control Side n=36 Participants Half of the abdominoplasty incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
Patient and Observer Scar Assessment Scale (POSAS) - Observer Results Vascularity	1.67 score on a scale Standard Deviation 0.63	2.25 score on a scale Standard Deviation 1.18
Patient and Observer Scar Assessment Scale (POSAS) - Observer Results Pigmentation	1.61 score on a scale Standard Deviation 0.77	2.69 score on a scale Standard Deviation 1.98
Patient and Observer Scar Assessment Scale (POSAS) - Observer Results Thickness	3.36 score on a scale Standard Deviation 3.20	3.50 score on a scale Standard Deviation 2.56
Patient and Observer Scar Assessment Scale (POSAS) - Observer Results Relief	2.56 score on a scale Standard Deviation 1.61	3.11 score on a scale Standard Deviation 1.86
Patient and Observer Scar Assessment Scale (POSAS) - Observer Results Pliability	1.67 score on a scale Standard Deviation 0.68	2.25 score on a scale Standard Deviation 1.00
Patient and Observer Scar Assessment Scale (POSAS) - Observer Results Surface Area	2.92 score on a scale Standard Deviation 2.18	2.81 score on a scale Standard Deviation 1.62
Patient and Observer Scar Assessment Scale (POSAS) - Observer Results Overall Opinion	1.61 score on a scale Standard Deviation 0.55	2.50 score on a scale Standard Deviation 1.38

SECONDARY outcome

Timeframe: 6 Months

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

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.

Outcome measures

Measure	Treated Side n=44 Participants Half of the abdominoplasty incision was treated with the embrace device.	Control Side Half of the abdominoplasty incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
Patient Satisfaction - Scar Minimization Very Satisfied	14 Participants	—
Patient Satisfaction - Scar Minimization Satisfied	18 Participants	—
Patient Satisfaction - Scar Minimization Neither Satisfied nor Dissatisfied	11 Participants	—
Patient Satisfaction - Scar Minimization Dissatisfied	1 Participants	—
Patient Satisfaction - Scar Minimization Very Dissatisfied	0 Participants	—

SECONDARY outcome

Timeframe: 6 Months

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

Subjects were were asked to rate how likely they were to recommend embrace treatment to a friend.

Outcome measures

Measure	Treated Side n=44 Participants Half of the abdominoplasty incision was treated with the embrace device.	Control Side Half of the abdominoplasty incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
Patient Satisfaction - Recommend Very Likely	16 Participants	—
Patient Satisfaction - Recommend Likely	19 Participants	—
Patient Satisfaction - Recommend Neither likely nor unlikely	4 Participants	—
Patient Satisfaction - Recommend Unlikely	3 Participants	—
Patient Satisfaction - Recommend Very Unlikely	2 Participants	—

SECONDARY outcome

Timeframe: 6 Months

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

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.

Outcome measures

Measure	Treated Side n=44 Participants Half of the abdominoplasty incision was treated with the embrace device.	Control Side Half of the abdominoplasty incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
Patient Satisfaction - Use Again Very likely	22 Participants	—
Patient Satisfaction - Use Again Likely	10 Participants	—
Patient Satisfaction - Use Again Neither likely nor unlikely	4 Participants	—
Patient Satisfaction - Use Again Unlikely	5 Participants	—
Patient Satisfaction - Use Again Very Unlikely	3 Participants	—

SECONDARY outcome

Timeframe: 12 Months

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

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.

Outcome measures

Measure	Treated Side n=35 Participants Half of the abdominoplasty incision was treated with the embrace device.	Control Side Half of the abdominoplasty incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
Patient Satisfaction - Scar Minimization Very Satisfied	14 Participants	—
Patient Satisfaction - Scar Minimization Satisfied	11 Participants	—
Patient Satisfaction - Scar Minimization Neither Satisfied nor Dissatisfied	10 Participants	—
Patient Satisfaction - Scar Minimization Dissatisfied	0 Participants	—
Patient Satisfaction - Scar Minimization Very Dissatisfied	0 Participants	—

SECONDARY outcome

Timeframe: 12 Months

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

Subjects were were asked to rate how likely they were to recommend embrace treatment to a friend.

Outcome measures

Measure	Treated Side n=35 Participants Half of the abdominoplasty incision was treated with the embrace device.	Control Side Half of the abdominoplasty incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
Patient Satisfaction - Recommend Very Likely	15 Participants	—
Patient Satisfaction - Recommend Likely	11 Participants	—
Patient Satisfaction - Recommend Neither Likely nor Unlikely	5 Participants	—
Patient Satisfaction - Recommend Unlikely	2 Participants	—
Patient Satisfaction - Recommend Very Unlikely	2 Participants	—

SECONDARY outcome

Timeframe: 12 Months

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

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.

Outcome measures

Measure	Treated Side n=35 Participants Half of the abdominoplasty incision was treated with the embrace device.	Control Side Half of the abdominoplasty incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
Patient Satisfaction - Use Again Very Likely	15 Participants	—
Patient Satisfaction - Use Again Likely	12 Participants	—
Patient Satisfaction - Use Again Neither Likely nor Unlikely	3 Participants	—
Patient Satisfaction - Use Again Unlikely	3 Participants	—
Patient Satisfaction - Use Again Very Unlikely	2 Participants	—

Adverse Events

Treatment Arm

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

All Study Participants

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment Arm n=67 participants at risk Half of the abdominoplasty incision was treated with the embrace device.	All Study Participants n=67 participants at risk 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.
Skin and subcutaneous tissue disorders Erythema	10.4% 7/67 • Number of events 11 • 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.	10.4% 7/67 • Number of events 11 • 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.
Skin and subcutaneous tissue disorders Infection	11.9% 8/67 • Number of events 8 • 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.	11.9% 8/67 • Number of events 8 • 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.
Skin and subcutaneous tissue disorders Maceration	7.5% 5/67 • Number of events 8 • 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.	7.5% 5/67 • Number of events 8 • 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.
Skin and subcutaneous tissue disorders Rash	9.0% 6/67 • Number of events 6 • 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.	9.0% 6/67 • Number of events 6 • 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.
Skin and subcutaneous tissue disorders Skin Irritation	35.8% 24/67 • Number of events 29 • 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.	35.8% 24/67 • Number of events 29 • 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.

Additional Information

Sr. Director of R&D

Neodyne Biosciences

Phone: 510-456-4128

Email: jjackson@neodynebio.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place