NCT06725459招募中不适用
Assessing the Application of Closed Incision Negative Pressure Wound Therapy to Reduction Mammaplasty
Medstar Health Research Institute2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2024年12月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Incidence of Postoperative Wound Complications
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Incidence of Postoperative Wound Complications
时间窗: 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).
次要结局
- Scar Quality (POSAS)(1 month and 3 months postoperatively)
- Patient-Reported Pain (VAS)(Immediate postoperative period, 1 week postoperatively, and 3 months postoperatively)
- Patient Satisfaction with Breasts (BREAST-Q)(Preoperative baseline, 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, and 6 months postoperatively)
- Cost Differential: Healthcare Resource Use(Through study completion, an average of 6 months)
- Cost Differential: Dressing-Related Costs(Through study completion, an average of 6 months)
研究者
研究点 (2)
Loading locations...
相似试验
撤回
1 期
CiNPWT Lower Extremity Amputations (Closed Incision Neagtive Pressure Wound Therapy)Wound HealWound DehiscenceNCT06493539University of Southern California10
终止
不适用
A Trial to Evaluate Negative Pressure Incision Management System for Groin Wounds in Vascular Surgery PatientsSurgical Procedure, UnspecifiedNCT02399111Northwell Health9
招募中
不适用
Closed or Open Abdomen for the Management of Abdominal SepsisAbdominal SepsisAbdominal InfectionNCT03163095University of Calgary550
进行中（未招募）
不适用
Cervical Radiculopathy TrialCervical RadiculopathyNCT03674619Oslo University Hospital180
进行中（未招募）
不适用
A Study Evaluating the Effect of Frozen-Section Directed Excision Surgery on Vulvar DysplasiaVulvar NeoplasmDysplasia VulvarNCT05934851Wake Forest University Health Sciences112