NPWT Reduction Mammaplasty

Launched by MEDSTAR HEALTH RESEARCH INSTITUTE · Dec 4, 2024

Keywords

ClinConnect Summary

This clinical trial, called NPWT Reduction Mammaplasty, is studying the effects of a special type of wound treatment known as Negative Pressure Wound Therapy (NPWT) compared to standard dressings after a surgery called reduction mammaplasty. This surgery is often performed on women with large breasts (macromastia) to help reduce size and alleviate discomfort. The researchers want to find out if using NPWT can help reduce complications, improve healing, and possibly lower costs compared to regular adhesive dressings.

To participate in this trial, women must be 18 years or older and scheduled for a specific type of breast reduction surgery at participating hospitals. Participants will be closely monitored during their recovery to see how well they heal and to gather information on their experiences. It’s important to note that there are some criteria that might exclude women from participating, such as being a smoker, having certain health conditions, or having a history of breast cancer. This study is currently recruiting participants, aiming to improve outcomes for women undergoing this common procedure.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female patients
• • Age 18 years or older
• • Scheduled to undergo bilateral reduction mammaplasty with a Wise pattern (anchor) incision and a superomedial, inferior, or central mound pedicle at MedStar Georgetown University Hospital or MedStar Good Samaritan Hospital
• • Able to comply with study procedures and follow-up visits
• Exclusion Criteria:
• • Younger than 18 years of age
• • Biologically male patients
• • Scheduled to undergo unilateral breast mammaplasty
• • Currently pregnant or lactating
• • Use of steroids or other immune modulators known to affect wound healing
• • Current smokers who have not paused for a minimum of 4 weeks prior to surgery
• • History of breast cancer
• • History of oncologic or reconstructive breast surgery
• • History of radiation to the breast
• • History of chemotherapy or hormone therapy
• • Tattoos in the area of skin incision
• • Skin conditions known to affect wound healing or scarring of the breast (e.g., cutis laxa)
• • Significant history of scar problems (e.g., hypertrophic scarring or keloids) post-surgical incisions with active bleeding
• • Exposure of blood vessels, organs, bone, or tendon at the base of the reference wound
• • Known allergies to product components (e.g., medical or NPWT tape)
• • Unable to comply with NPWT requirements, including those unable to present for postoperative follow-up
• • Lactating at the time of surgery
• • Require deviation from standard operative or closure techniques (e.g., staples, free nipple grafts)
• • Considered part of a vulnerable population (adults unable to consent, infants, children, teenagers, pregnant women, prisoners)
• • Experience intraoperative complications due to surgical complications not related to the NPWT instrumentation (e.g., expanding hematoma)