NCT01399099

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2011

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 21, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

December 25, 2014

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

1.3 years

First QC Date

June 27, 2011

Results QC Date

December 17, 2014

Last Update Submit

November 14, 2024

Conditions

Hypertrophic

Keywords

scarincisionwound healingscarringpost-surgical

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (10)

  • Patient and Observer Scar Assessment Scale (POSAS) - Patient Results

    6 Months

  • Patient and Observer Scar Assessment Scale (POSAS) - Patient Results

    12 Months

  • Patient and Observer Scar Assessment Scale (POSAS) - Observer Results

    6 Months

  • Patient and Observer Scar Assessment Scale (POSAS) - Observer Results

    12 Months

  • Patient Satisfaction - Scar Minimization

    6 Months

  • +5 more secondary outcomes

Study Arms (2)

embrace Dressing

EXPERIMENTAL

Investigational Dressing

Device: embrace device

Standard of Care

NO INTERVENTION

Standard of care comparator

Interventions

embrace deviceDEVICE

Adhesive bandage/dressing intended to minimize scar formation.

Also known as: Neodyne Device, embrace dressing, Neodyne Dressing
embrace Dressing

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Atherton Plastic Surgery

Atherton, California, 94027, United States

Location

Vipul R. Dev MD

Bakersfield, California, 93308, United States

Location

Elite MD

Danville, California, 94526, United States

Location

Kaufman and Clark Plastic Surgery

Folsom, California, 95630, United States

Location

The Aesthetic Institute

Fullerton, California, 92835, United States

Location

The Korman Group

Mountain View, California, 94040, United States

Location

Newport Plastic Surgery

Newport Beach, California, 92660, United States

Location

Lauren Greenberg, MD

Palo Alto, California, 94304, United States

Location

Plastic Surgery Associates of Santa Rose

Santa Rosa, California, 95409, United States

Location

Joseph Mele, MD

Walnut Creek, California, 94598, United States

Location

Academy of Clinical Research

Arlington, Texas, 76011, United States

Location

The University of Texas Southwestern Medical Center - Dept. of Plastic Surgery

Dallas, Texas, 75390-9132, United States

Location

US Army Institute of Surgical Research

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (1)

  • 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.

    PMID: 24804638DERIVED

MeSH Terms

Conditions

HypertrophyCicatrixSurgical Wound

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsFibrosisPathologic ProcessesWounds and Injuries

Limitations and Caveats

* 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/

Results Point of Contact

Title
Sr. Director of R&D
Organization
Neodyne Biosciences
jjackson@neodynebio.com
510-456-4128

Study Officials

  • Rodney J Rohrich, MD, FACS

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2011

First Posted

July 21, 2011

Study Start

June 1, 2011

Primary Completion

September 1, 2012

Study Completion

March 1, 2013

Last Updated

November 19, 2024

Results First Posted

December 25, 2014

Record last verified: 2024-11

Locations

US(13)