Clinical Evaluation of the GLYDe Dressing for Post-surgical Incision Care (Mona Lisa)

Neodyne Biosciences

Status: Completed

Conditions: Post Surgical Incisions From Abdominoplasty Procedures

Treatments: Device: GLYDe Dressing

Study type: Interventional

Funder types: Industry

Identifiers

NCT00766727

CA001

Details and patient eligibility

About

This study will evaluate a new dressing to be used for post-incision care for abdominoplasty patients. The hypothesis is that this dressing will minimize scar formation.

Full description

This study will evaluate a new dressing in up to 30 patients who have undergone an abdominoplasty procedure. They will wear the dressing through 8 weeks post surgery and the scar will be evaluated at 3 months post surgery.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subjects who have undergone an abdominoplasty 1 week prior to study participation

Exclusion criteria

• subjects with a history of collagen vascular disease or scleroderma
• subjects with known adverse reactions to steri-strips, medical tapes or adhesives

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 2 patient groups

GLYDe Dressing

Experimental group

Description:

Investigational Dressing

Treatment:

Device: GLYDe Dressing

Standard of Care

No Intervention group

Description:

Standard of care comparator