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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 30 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Immediate postoperative period, 1 week postoperatively, and 3 months postoperatively |
| Scar Quality (POSAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ryan P Lin, MD | Contact | 2407787804 | 1 | Ryan.Lin@medstar.net |
| Kenneth L Fan, MD | Contact | (202) 444-8751 | 1 | kenneth.l.fan@medstar.net |
| Name | Affiliation | Role |
|---|---|---|
| Kenneth L Fan, MD | MedStar Georgetown University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medstar Georgetown University Hospital | Recruiting | Washington D.C. | District of Columbia | 20007 | United States |
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| ID | Term |
|---|---|
| C536821 | Gigantomastia |
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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.
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| 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. |
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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). |
| 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. | 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. | 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. | Through study completion, an average of 6 months |