Healthy, Macromastia, Mammaplasty, Negative Pressure Therapy, Wound Healing
Conditions
Keywords
mammaplasty, macromastia, breast reduction, negative pressure therapy
Brief summary
In this prospective, randomized, split-body control trial, we aim to compare complications, patient-reported outcomes, and cost differentials following reduction mammaplasty with prophylactic closed incision negative pressure wound therapy versus standard adhesive dressing.
Interventions
DEVICEProphylactic ciNPWT
The prophylactic closed incision negative pressure wound therapy (ciNPWT) will be applied to one breast for up to 7 days postoperatively to promote wound healing and prevent complications.
OTHERStandard Adhesive Dressing
The standard adhesive strip dressing will be applied to one breast immediately after surgery. It provides a protective covering for the wound during the initial healing phase and is the standard of care for incision management.
Sponsors
3M
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The Prevena Restor Bella Form™ wound vacuum will be applied to the reduction mammaplasty incision as directed for up to 7 days postoperatively. Prevena Restor Bella Form™ is a ciNPWT management system. ciNPWT management systems apply negative pressure to the incision and structurally stabilize the surrounding tissues.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Wound Complications | 30 days postoperatively | The primary outcome measure is the incidence of postoperative wound complications within 30 days following reduction mammaplasty. This includes surgical wound dehiscence, delayed wound healing, and surgical site infections (SSIs). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Pain (VAS) | Immediate postoperative period, 1 week postoperatively, and 3 months postoperatively | Patient-reported pain will be assessed using the Visual Analog Scale (VAS) with scores ranging from 0 (no pain) to 10 (maximal imaginable pain). |
| Scar Quality (POSAS) | 1 month and 3 months postoperatively | Scar quality will be assessed using the Patient and Observer Scar Assessment Scale (POSAS) at 1 and 3 months postoperatively. The scale ranges from 6 (normal skin) to 60 (worst imaginable scar). |
| Patient Satisfaction with Breasts (BREAST-Q) | Preoperative baseline, 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, and 6 months postoperatively | Patient satisfaction with their breasts will be measured using the standardized BREAST-Q 2.0© questionnaire at the preoperative consultation, and at 1 week, 1 month, 3 months, and 6 months postoperatively. |
| Cost Differential: Dressing-Related Costs | Through study completion, an average of 6 months | Costs associated with dressings will include the unit price of ciNPWT and standard adhesive dressings and healthcare professional time for application and removal. |
| Cost Differential: Healthcare Resource Use | Through study completion, an average of 6 months | Healthcare resource use will include hospital stay durations, additional procedures for managing complications, and any unplanned follow-up visits. |
Countries
United States
Contacts
Primary ContactRyan P Lin, MD
Backup ContactKenneth L Fan, MD
Outcome results
None listed