Investigation of a Novel Silicone Dressing to Maximize the Outcomes of Scar Revision Procedures (IMPROVE)

NCT01430130 | Completed Results

• 1 other identifier: CA005
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic

Keywords

scar; incision; wound healing; scarring; scar revision

Outcome Measures

Primary Outcomes (1)

• 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 (4)

• Subject and Investigator Satisfaction With the Aesthetic Results

  Up to 12 months

• Ease of Use

  Up to 12 months

• Comfort Level Related to Study Device Application, Wear and Removal

  Up to 12 weeks

• Comparison of Scar Smoothness of Treated Side as Compared to the Control Side

  Up to 12 months

Study Arms (1)

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.

Device: embrace device

Interventions

embrace device DEVICE

Adhesive bandage/dressing intended to minimize scar formation.

Also known as: Neodyne dressing

All Study Participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neodyne Biosciences, Inc.: lead

Study Sites (1)

Duet Plastic Surgery

Palo Alto, California, 94306, United States

Location

MeSH Terms

Conditions

Hypertrophy; Cicatrix; Surgical Wound

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Fibrosis; Pathologic Processes; Wounds and Injuries

Limitations and Caveats

The Neodyne Dressing is referred to as the "embrace device."

Results Point of Contact

• Title: Kristin Prosak
• Organization: Neodyne Biosciences

kprosak@neodynebio.com

650-543-7129

Study Officials

• Jennifer Weintraub, MD

  Duet Plastic Surgery

  PRINCIPAL INVESTIGATOR

• Angeline Lim, MD

  Duet Plastic Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2011
• First Posted: September 7, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 28, 2014
• Results First Posted: November 28, 2014

Record last verified: 2014-11

Locations

US (1)