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NPWT Reduction Mammaplasty

ConditionsHealthyMacromastiaNegative Pressure TherapyMammaplastyWound Healing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMedstar Health Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Younger than 18 years of age

Biologically male patients

Scheduled to undergo unilateral breast mammaplasty

Currently pregnant or lactating

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

92 Participants
are divided into 2 treatment groups
Group A: Prophylactic ciNPWTExperimental treatment 1 intervention
Group B: Standard Adhesive DressingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medstar Health Research Institute

Lead sponsor

3M

Collaborator

Source ClinicalTrials.gov
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