RECRUITING

NPWT Reduction Mammaplasty

Conditions

Healthy Macromastia Negative Pressure Therapy Mammaplasty Wound Healing breast reduction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Assessing the Application of Closed Incision Negative Pressure Wound Therapy to Reduction Mammaplasty

Quick Facts

Study Start:2024-12-17

Study Completion:2025-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06725459

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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 * 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)

Inclusion Criteria

Exclusion Criteria

* 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

* 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
* 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)

Contacts and Locations

Study Contact

Kenneth L Fan, MD

CONTACT

(202) 444-8751

kenneth.l.fan@medstar.net

Rachel N Rohrich, BS

CONTACT

2147632210

rachel.rohrich@medstar.net

Principal Investigator

Kenneth L Fan, MD

PRINCIPAL_INVESTIGATOR

MedStar Georgetown University Hospital

Study Locations (Sites)

Medstar Georgetown University Hospital

Washington, District of Columbia, 20007

United States

Collaborators and Investigators

Sponsor: Medstar Health Research Institute

Kenneth L Fan, MD, PRINCIPAL_INVESTIGATOR, MedStar Georgetown University Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-17

Study Completion Date2025-11-01

Study Record Updates

Study Start Date2024-12-17

Study Completion Date2025-11-01

Terms related to this study

Keywords Provided by Researchers

mammaplasty
macromastia
breast reduction
negative pressure therapy

Additional Relevant MeSH Terms

Healthy
Macromastia
Negative Pressure Therapy
Mammaplasty
Wound Healing