Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

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

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

OxyGenesys Dissolved Oxygen Dressing

Standard Gauze Dressing

David T Curd, MS

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.

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.

Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy

A Prospective, Multi-Center, Randomized, Open Label Controlled Trial Using a Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy

Patient and Observer Scar Assessment Scale - range = 1 - 10. "1" is best condition ("normal skin") and "10" is worst condition ("worst scar imaginable"). The scale is used to assess each of six different wound characteristics, including vascularity, pigmentation, thickness, relief, pliability, and surface area. The means of these combined scores and their respective standard deviations are reported for each study group. The range of the final evaluation score, based on the collective evaluation of each of the six wound characteristics is "6" (if each of the six scores equals "1") to "60" (if each of the six scores equals "10").

Numerical Rating Scale (NRS) - range = 0 - 10. "0" corresponds to "no pain" and "10" indicates "worst pain imaginable". The means of these scores and their respective standard deviations are reported for each study group.

Halyard Health

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

OxyGenesys Dissolved Oxygen Dressing

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

Standard Gauze Dressing

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

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

Each study participant was supposed to act as her own control (one breast to be treated with the test article, the other breast with the control article).

OxyGenesys Dissolved Oxygen Dressing and Gauze Dressing

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Director of Clinical Affairs

Each participant acted as her own control - one breast of each participant received the OxyGenesys Dressing, the other breast received the standard dressing.

Evaluate the Effects of OxyGenesys Dissolved Oxygen Dressing in Wound Complication Rates of the Nipple Areolar Complex Post Nipple-sparing Mastectomy

Each participant acted as her own control - one breast received OxyGenesys, while the other breast received the standard dressing. Two patients in the OxyGenesys study arm, and one patient in the Control study arm did not provide follow-up data.

To Evaluate Scar Formation 30 Days Post Nipple-sparing Mastectomy

Each study participant was treated with OxyGenesys Dissolved Oxygen Dressing on one breast and standard gauze dressing on the opposite breast.

All Available Study Participants

There is just one NRS value calculated for the indicated time-frame, and thus a comparison between study groups with respect to this outcome was not made. The single NRS value at 30 days is reported here. One patient did not provide follow-up data at this time-point, and thus the total number of participants is 26 instead of 27 for this outcome.

To Assess Pain Using the Numerical Rating Scale

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

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

Each study participant acted as her own control (one breast of each participant was treated with OxyGenesys, while the other breast was treated with the standard dressing (control)).

Overall Study

Diseases and Abnormalities at or Before Birth

Carcinoma

Congenital Abnormalities

Carcinoma, Ductal

Carcinoma, Ductal, Breast

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Adenocarcinoma

Autologous fat harvested from the patient is enhanced with ADRCs derived from a portion of the harvested fat and transplanted into the breast(s) that have a volume deficit post lumpectomy. This is a single arm study with no control. All patients receive cell therapy.

ADRC-Enhanced Autologous Fat Transplant

A post-marketing study evaluating the transplantation of autologous fat augmented with Adipose Derived Regenerative Cells (ADRCs), in patients with functional and cosmetic breast deformities post segmental mastectomy or quadrantectomy (lumpectomy).

Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy

A Clinical Evaluation Of Adipose Derived Regenerative Cells In The Treatment Of Patients With BrEast Deformities Post Segmental Breast ResecTion (Lumpectomy) With Or Without Radiation ThErapy. A Phase IV Post Market Study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy	NCT01796977	Breast Cancer Reconstructive ...	OxyGenesys Diss... Standard Gauze ...	21 Years -	Halyard Health
Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy	NCT00616135	Breast Neoplasm... Carcinoma, Duct... Mammaplasty Mastectomy, Seg...	ADRC-Enhanced A...	18 Years - 75 Years	Cytori Therapeutics

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