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

Neodyne Biosciences

Status: Completed

Conditions: Hypertrophic

Treatments: Device: embrace device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01430130

CA005

Details and patient eligibility

About

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.

Full description

It is proposed to study a dressing designed to reduce the appearance of scars after scar revision surgery. It is expected that by managing the incision site after primary closure but during the longer term healing phase, scar formation may be minimized.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

All Study Participants

Experimental group

Description:

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.

Treatment:

Device: embrace device