Closed Incision Negative Pressure Therapy Compared to Conventional Dressing Following Autologous Abdominal Tissue Breast Reconstruction: A Pilot Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- Percentage of Patient Recruitment - Study Feasibility
研究概览
简要总结
In women who undergo mastectomy for the treatment of breast cancer, autologous reconstruction using the deep inferior epigastric perforator (DIEP) flap is a common surgical procedure that aims to restore both the appearance and texture of the breast(s). Specifically, this requires the transfer of skin, fat, and perforator vessels from the abdomen to a recipient artery and vein in the chest to create a viable breast mound. Post-operatively, the abdominal donor site is routinely monitored for wound dehiscence, which has a reported incidence of up to 39% in this patient population; however, this incidence typically varies from 3.5% to 14%.
At the investigators' academic institution, patients who undergo DIEP breast reconstruction typically have closed incision negative pressure therapy (ciNPT) or traditional tape dressings applied to the closed abdominal donor site. These dressings are selected according to surgeon preference and typically remain in-situ until hospital discharge. As there remains clinical equipoise regarding the ability of ciNPT to reduce abdominal wound dehiscence, further research in the form of a parallel, two-arm RCT is warranted.
The investigators propose a pilot study comparing ciNPT to standard tape dressings to the abdominal donor site incision for patients undergoing autologous DIEP breast reconstruction. As a pilot trial, the primary objective of the study is to assess feasibility outcomes. The design and conduct of the proposed pilot study will mirror the methodology of the definitive trial including randomization, interventions, and clinical outcomes. The secondary objective of this study is to evaluate clinical outcomes comparing ciNPT to standard tape dressings applied to the abdominal donor site incision. Clinical outcomes will include: 1) the incidence of abdominal wound dehiscence at 4 weeks following DIEP breast reconstruction; 2) the incidence of seroma formation and surgical site infection at 4 weeks; 3) quality of life as measured by BREAST-Q physical well-being abdomen and EQ-5D-5L pre-operatively, 1-month, 6-months, and 12-months postoperatively; 4) Scar appearance as measured by the SCAR-Q at 12-months postoperatively.
The pilot RCT will demonstrate feasibility of a definitive trial comparing ciNPT to standard tape dressings for the abdominal donor site of patients undergoing DIEP breast reconstruction. A priori hypotheses for each feasibility outcome will be:
- Eligibility: At least 90% of screened patients will be eligible.
- Recruitment: At least 85% of eligible patients will be enrolled. To be considered fully enrolled patients must sign the informed consent form, complete baseline demographic questionnaires, and be randomized to a study arm.
- Retention: At least 85% of randomized patients will complete the study, defined as completion of 12-month follow-up
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •adult female patients (≥ 18 years old)
- •consent to elective immediate (i.e. performed at the time of mastectomy) or delayed (i.e. performed following mastectomy) breast reconstruction using the DIEP flap
排除标准
- •patients who are pregnant
- •have a documented/reported allergy to adhesive dressings
结局指标
主要结局
Percentage of Patient Recruitment - Study Feasibility
时间窗: 12 months
The percentage of patients that are enrolled in the study among those determined to be eligible will be recorded. To be considered fully enrolled patients must sign the informed consent form, complete baseline demographic questionnaires, and be randomized to a study arm. This criteria will be determined to be feasible if at least 85% of eligible patients are recruited.
Percentage of Patient Eligibility - Study Feasibility
时间窗: 12 months
The percentage of patients that are eligible for the study among those that are screened will be recorded. This criteria will be determined to be feasible if at least 90% of screened patients are deemed to be eligible.
Percentage of Patient Retention - Study Feasibility
时间窗: 12 months
The percentage of patients that complete the study among those that are randomized will be recorded. Completion of the study will be defined as completion of 12 month follow-up questionnaires. This criteria will be determined to be feasible if at least 85% of randomized patients complete the study. As per Thabane et al., the investigators will collate the results of all three of the aforementioned primary outcomes to determine study eligibility. If all three criteria are met, the authors will decide that the study is feasible and continue without modifications. If one or more criteria is not met, the investigators will either decide to: Stop - main study not feasible, or Continue, but modify protocol - feasible with modifications, or Continue without modifications, but monitor closely - feasible with close monitoring
次要结局
- BREAST-Q physical well-being abdomen - Patient Quality of Life(12 months)
- SCAR-Q - Patient Quality of Life(12 months)
- Percentage of participants with Seroma Formation(4 weeks)
- Percentage of participants with Abdominal Wall Dehiscence(4 weeks)
- Percentage of participants with Surgical Site Infection(4 weeks)
- 5-level EQ-5D version (EQ-5D-5L) - Patient Quality of Life(12 months)