HealthyNCT06725459
NPWT Reduction Mammaplasty
A study testing Prophylactic ciNPWT and Standard Adhesive Dressing in people with Healthy and Macromastia, run by Medstar Health Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Healthy, Macromastia, Negative Pressure Therapy
- What is being tested?
- Prophylactic ciNPWT and Standard Adhesive Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2024to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Kenneth L Fan, MD, 202-444-8751, kenneth.l.fan@medstar.net
Ryan P Lin, MD, 2407787804 ext. 1, Ryan.Lin@medstar.net
About this study
Official title: Assessing the Application of Closed Incision Negative Pressure Wound Therapy to Reduction Mammaplasty
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
- Being tested
- Prophylactic ciNPWT, Standard Adhesive Dressing
- Keywords
- mammaplasty, macromastia, breast reduction, negative pressure therapy
- Medical subject headings
- Gigantomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic ciNPWTDevice
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 DressingOther
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 group | Role | What they receive |
|---|---|---|
| Prophylactic ciNPWT | Experimental | 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. Receives: Device: Prophylactic ciNPWT |
| Standard Adhesive Dressing | Active comparator | 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. Receives: Other: Standard Adhesive Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days postoperatively
Secondary outcomes (5)
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start17 Dec 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Prevena Restor Bella Form™ wound vacuum will be applied to the reduction mammaplasty incision as directed for up to 7 days postoperatively. Prevena Restor Bella Form™ is a ciNPWT management system. ciNPWT management systems apply negative pressure to the incision and structurally stabilize the surrounding tissues.
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Kenneth L Fan, MD, Principal investigator, MedStar Georgetown University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725459
- Sponsor's protocol ID
- STUDY00007266
- Status last verified
- Oct 2025
- First submitted
- 15 Nov 2024
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Application of Closed Incision Negative Pressure Wound Therapy to Reduction Mammaplasty
- ClinicalTrials.gov ID
- NCT06725459
- Acronym / sponsor ID
- STUDY00007266
- Conditions
- Healthy, Macromastia, Negative Pressure Therapy, Mammaplasty, Wound Healing
- Keywords
- mammaplasty, macromastia, breast reduction, negative pressure therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- 3M
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The Prevena Restor Bella Form™ wound vacuum will be applied to the reduction mammaplasty incision as directed for up to 7 days postoperatively. Prevena Restor Bella Form™ is a ciNPWT management system. ciNPWT management systems apply negative pressure to the incision and structurally stabilize the surrounding tissues.
| Arm | Type | Receives |
|---|---|---|
| Prophylactic ciNPWT | Experimental | Device: Prophylactic ciNPWTParticipants 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. |
| Standard Adhesive Dressing | Active comparator | Other: Standard Adhesive DressingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prophylactic ciNPWTThe 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. | Device | Prophylactic ciNPWT |
| Standard Adhesive DressingThe 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. | Other | Standard Adhesive Dressing |
Primary outcome
Incidence of Postoperative Wound Complications
Time frame: 30 days postoperatively
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).
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kenneth L Fan, MD principal investigator
MedStar Georgetown University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic ciNPWT and Standard Adhesive Dressing in people with Healthy and Macromastia, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan P Lin, MD (2407787804 ext. 1, Ryan.Lin@medstar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Wound Complications (time frame: 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.