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

Breast Diseases

Skin Diseases

Subjects randomized to this arm will undergo robotic NSM (RNSM) procedures

Subjects randomized to this arm will undergo conventional open NSM procedures

Robotic-assisted Nipple sparing mastectomy procedures

Robotic NSM

open nipple-sparing mastectomy procedures

Open NSM

Kathryn Wine

Jennifer Tseng, MD

Stephanie Casal, MS, RN, CNS

Jamie Rand, MD

Mouchammed Agko, MD

Antoine Carre, MD

Katharine Schulz-Costello, DO

Farin Amersi, MD

Alice Chung, MD

Kjirsten Carlson, MD

Marissa Boyle, MD

Edward Ray, MD

Adna Makerevic

James Jakub, MD

Brian Rinker, MD

Sarah McLaughlin, MD

Olivia Ho, MD

Tammeza Gibson, PA

Cathy Graham, MD

Clara Farley, MD

Sarah Apatov, PA

Peter Thompson, MD

Duanny Alva

Anne Jankowski

Katherine Kopkash, MD

Nayana Dekhne, MD

Jesse Selber, MD

Mara Piltin, DO

Clinical Coordinator

Rebecca Aft, MD

Joani Christensen, MD

Sabah Iqbal

Alan Kadison, MD

Gary Deutsche, MD

Neil Tanna, MD

Armen Kasabian, MD

Kimberly Turnage, MSN

Adi Molvin

Akiko Chiba, MD

Shelley Hwang, MD

Laura Rosenberger, MD

Geoffrey Sisk, MD

Rebecca Knackstedt, MD

Maggie Dinome, MD

Juliana Ruiz

Ari Brooks, MD

Kathy Taylor

Kelly Hewitt, MD

John Tran

Rosa Hwang, MD

Solange Cox, MD

Renee Largo, MD

John Shuck, MD

Erin Fannon

Sara Javid, MD

Meghan Flanagan, MD

Suzanne Marie Inchauste, MD

Alysandra Lal, MD

John Yousif, MD

This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.

This study is a prospective, two-arm, multi-center, randomized controlled clinical investigation between RSNM and open NSM.

This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.

Subjects undergo nipple-sparing mastectomy (NSM) procedures using the da Vinci SP Surgical System or open NSM

Robotic vs. Open NSM for Early Stage Breast Cancer

A Prospective, Multicenter Randomized Controlled Trial(RCT) of the da Vinci® SP™ Surgical System vs Open Surgery in Nipple Sparing Mastectomy (NSM) Procedures

Conversion is defined as conversion of da Vinci Xi robotic-assisted surgery to open surgery

Incidence of intraoperative and post-operative procedure and device-related adverse events compared to open NSM

Incidence of positive surgical margins compared to open NSM

Intuitive Surgical

Wounds and Injuries

Surgical Wound

Imframammary- NSM using imframammary incision

Radial/Peri-areolar- NSM using Radial/Peri-areolar incision

Nipple sparing mastectomy was performed using Radial/Peri-areolar incision or imframammary incision

Nipple sparing mastecomy with different incision placements

This study aims to assess nipple areolar complex sensation after nipple sparing mastectomy and compare the results according to different incisional approaches; specifically, inframammary fold (IMF) versus peri-areolar/radial. One-hundred-and-five post NSM patients from Oct 2019 to Nov 2021 have been recruited prospectively and evaluated for NAC sensory. A total of 97 patients (IMF 65 and peri-areolar/radial 32) were included in the analyses for comparison during follow up from 24 to 48 months after surgery. It was hypothesized that patients with IMF would have better outcomes for NAC senroy.

Comparison of Nipple-areolar Complex Sensation According to Incision Types in Nipple-sparing Mastectomy

Difference in NAC sensory loss between the patients with two different incisions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy	NCT01796977	Breast Cancer Reconstructive ...	OxyGenesys Diss... Standard Gauze ...	21 Years -	Halyard Health
Robotic vs. Open NSM for Early Stage Breast Cancer	NCT05720039	Breast Cancer F... Breast Cancer Breast Cancer, ... Breast Disease Breast	Robotic NSM Open NSM	21 Years -	Intuitive Surgical
Comparison of Nipple-areolar Complex Sensation According to Incision Types in Nipple-sparing Mastectomy	NCT05917834	Breast Cancer Nipple Sparing ...	Nipple sparing ...	18 Years -	Gangnam Severance Hospital
Robotic vs. Open NSM for Early Stage Breast Cancer	NCT05720039	Breast Cancer F... Breast Cancer Breast Cancer, ... Breast Disease Breast	Robotic NSM Open NSM	21 Years -	Intuitive Surgical

Spots Global Cancer Trial Database for nsm

Every month we try and update this database with for nsm cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nsm

Every month we try and update this database with for nsm cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nsm cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.