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Recruiting NCT06725459

NPWT Reduction Mammaplasty

No phase Interventional Healthy Macromastia Negative Pressure Therapy Mammaplasty

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prophylactic ciNPWT, Standard Adhesive Dressing.
Who it may be relevant to
Registry conditions: Healthy, Macromastia, Negative Pressure Therapy, Mammaplasty. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Assessing the Application of Closed Incision Negative Pressure Wound Therapy to Reduction Mammaplasty

Overview

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

  • Device Prophylactic 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.
  • Other Standard 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.

Primary outcome measures

  • Incidence of Postoperative Wound Complications [Time frame: 30 days postoperatively]
Secondary outcome measures (5)
  • Patient-Reported Pain (VAS) [Time frame: Immediate postoperative period, 1 week postoperatively, and 3 months postoperatively]
  • Scar Quality (POSAS) [Time frame: 1 month and 3 months postoperatively]
  • Patient Satisfaction with Breasts (BREAST-Q) [Time frame: Preoperative baseline, 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, and 6 months postoperatively]
  • Cost Differential: Dressing-Related Costs [Time frame: Through study completion, an average of 6 months]
  • Cost Differential: Healthcare Resource Use [Time frame: Through study completion, an average of 6 months]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Medstar Georgetown University Hospital — Washington D.C.

Identifiers

NCT: NCT06725459 · STUDY00007266

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗