NPWT Reduction Mammaplasty

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Medstar Health Research Institute
Study ID
NCT06725459
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prophylactic ciNPWT — DEVICE
    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.
  • Standard Adhesive Dressing — OTHER
    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.

Study Details

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.

Key Dates

Start date
Dec 17, 2024
Status verified
Oct 2025
Primary completion
Jul 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Prophylactic ciNPWT
    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.
  • Active Comparator: Standard Adhesive Dressing
    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.

Primary Outcome Measure

Incidence of Postoperative Wound Complications [ Time Frame: 30 days postoperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medstar Georgetown University HospitalWashington D.C.District of Columbia20007
Kenneth L Fan, MD
[email protected]
202-444-8751
Ryan P Lin, MD
[email protected]
2407787804
Kenneth L Fan, MD (PRINCIPAL_INVESTIGATOR)

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Medstar Georgetown University Hospital· Washington D.C., DC

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