An interventional study of Prophylactic ciNPWT and Standard Adhesive Dressing in Healthy, Macromastia and Negative Pressure Therapy, sponsored by Medstar Health Research Institute. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-27.
Sponsored by Medstar Health Research Institute · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Participants in this arm will receive the prophylactic closed incision negative pressure wound therapy (ciNPWT) on one breast following reduction mammaplasty. The ciNPWT will be applied for up to 7 days postoperatively to promote wound healing and prevent complications.
Device: Prophylactic ciNPWT
Participants in this arm will receive the standard adhesive strip dressing (Prineo Ethicon NJ) on the other breast following reduction mammaplasty. The standard dressing will be used as a control to compare postoperative outcomes against the ciNPWT.
Other: Standard Adhesive Dressing
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.
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.
Incidence of Postoperative Wound Complications
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).
Time frame: 30 days postoperatively
Patient-Reported Pain (VAS)
Patient-reported pain will be assessed using the Visual Analog Scale (VAS) with scores ranging from 0 (no pain) to 10 (maximal imaginable pain).
Time frame: Immediate postoperative period, 1 week postoperatively, and 3 months postoperatively
Scar Quality (POSAS)
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).
Time frame: 1 month and 3 months postoperatively
Patient Satisfaction with Breasts (BREAST-Q)
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.
Time frame: Preoperative baseline, 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, and 6 months postoperatively
Cost Differential: Dressing-Related Costs
Costs associated with dressings will include the unit price of ciNPWT and standard adhesive dressings and healthcare professional time for application and removal.
Time frame: Through study completion, an average of 6 months
Cost Differential: Healthcare Resource Use
Healthcare resource use will include hospital stay durations, additional procedures for managing complications, and any unplanned follow-up visits.
Time frame: Through study completion, an average of 6 months
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Gigantomastia
Medstar Health Research Institute