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NPWT Reduction Mammaplasty

NCT06725459 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-10-27

No results posted yet for this study

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.

Conditions

  • Healthy
  • Macromastia
  • Negative Pressure Therapy
  • Mammaplasty
  • Wound Healing

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.

Sponsors & Collaborators

  • 3M

    collaborator INDUSTRY

  • Medstar Health Research Institute

    lead OTHER

Principal Investigators

  • Kenneth L Fan, MD · MedStar Georgetown University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-17
Primary Completion
2026-07-01
Completion
2026-11-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06725459 on ClinicalTrials.gov