Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
92 participants
INTERVENTIONAL
2024-12-17
2026-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Negative Pressure Wound Therapy in Healing Abdominal Incision in Obese Patients Undergoing Breast Reconstruction Surgery
NCT04003038
ciNPT in Autologous Abdominal Tissue Breast Reconstruction
NCT04985552
ciNPT in Autologous DIEP Flap Breast Reconstruction
NCT05907941
iNPWT in Immediate Breast Reconstruction
NCT03069885
Prevention of the Risk of Complete Sternotomy Scar Dehiscence in Cardiac Surgery: A Clinical Investigation Comparing Negative Pressure Wound Therapy (NPWT) vs. Standard Dressing
NCT06207630
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
3M
INDUSTRY
Medstar Health Research Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kenneth L Fan, MD
Role: PRINCIPAL_INVESTIGATOR
MedStar Georgetown University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY00007266
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.