Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy (NSM)

Halyard Health

Status: Terminated

Conditions: Breast Cancer; Reconstructive Breast Surgery

Treatments: Device: OxyGenesys Dissolved Oxygen Dressing; Device: Standard Gauze Dressing

Study type: Interventional

Funder types: Industry

Identifiers

NCT01796977

100-12-0001

Details and patient eligibility

About

This study will evaluate the effect of OxyGenesys Dissolved Oxygen Dressing in wound complication rates of the nipple areolar complex after a nipple sparing mastectomy.

Full description

This study will recruit women who are undergoing a bilateral mastectomy for either cancer or a positive BRCA gene. Women will be randomized to a different treatment per breast. One breast will receive the OxyGenesys dressing and the other will receive the standard gauze dressing. The study will evaluate wound complication rates and compare the two treatments.

Enrollment: 27 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is able to give written consent
• Females >21 years of age
• At least one breast diagnosed with cancer or mastectomy due to a positive BRCA gene mutation test.
• Subject is indicated for bilateral nipple-sparing mastectomy surgery with immediate breast reconstruction
• Subject is able to comply with the study protocol

Exclusion criteria

• Primary tumor(s) located within 2cm of the areola margins
• Inability to perform follow up assessments
• Radiation treatment within 30 days of surgery
• Dermabond or other forms of surgical glue is used in the peri-areola region
• Subjects who are known to be allergic to any of the test product(s) or any component of the test product(s)
• Women who are pregnant
• Subjects who have been treated with an investigational drug or device within the past 30 days prior to enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups, including a placebo group

OxyGenesys Dissolved Oxygen Dressing

Active Comparator group

Description:

OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.

Treatment:

Device: OxyGenesys Dissolved Oxygen Dressing

Standard Gauze Dressing

Placebo Comparator group

Description:

A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.

Treatment:

Device: Standard Gauze Dressing