ciNPT in Autologous Abdominal Tissue Breast Reconstruction
- Conditions
- Breast Cancer
- Interventions
- Procedure: DIEP Breast ReconstructionDevice: ciNPTOther: Conventional Tape Dressings
- Registration Number
- NCT04985552
- Lead Sponsor
- McMaster University
- Brief Summary
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:
1. Eligibility: At least 90% of screened patients will be eligible.
2. 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.
3. Retention: At least 85% of randomized patients will complete the study, defined as completion of 12-month follow-up
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 24
- 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
- patients who are pregnant
- have a documented/reported allergy to adhesive dressings
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ciNPT ciNPT - Conventional tape dressings Conventional Tape Dressings - Conventional tape dressings DIEP Breast Reconstruction - ciNPT DIEP Breast Reconstruction -
- Primary Outcome Measures
Name Time Method Percentage of Patient Eligibility - Study Feasibility 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 Recruitment - Study Feasibility 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 Retention - Study Feasibility 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
- Secondary Outcome Measures
Name Time Method BREAST-Q physical well-being abdomen - Patient Quality of Life 12 months The BREAST-Q physical well-being abdomen is a patient-reported outcome measure (PROM) designed to measure the negative physical sequelae of the abdomen following autologous tissue reconstruction. Total scores are converted to an equivalent Rasch transformed score from 0 to 100. 0 represents the worst outcome and 100 represents the best outcome.
SCAR-Q - Patient Quality of Life 12 months The BREAST-Q physical well-being abdomen is a patient-reported outcome measure (PROM) designed to measure the the appearance, symptoms, and psychosocial impact of scars. Total scores are converted to an equivalent Rasch transformed score from 0 to 100. 0 represents the worst outcome and 100 represents the best outcome.
Percentage of participants with Seroma Formation 4 weeks seroma formation - defined by the presence of a symptomatic, subcutaneous fluid collection (diagnosed clinically or by ultrasound per clinician judgement)
Percentage of participants with Abdominal Wall Dehiscence 4 weeks the between-group difference in the incidence of abdominal wound dehiscence- 'wound dehiscence' will be defined as the partial or full-thickness separation of the abdominal wound incision necessitating routine dressing changes, surgical debridement, or revision of the abdominal incision
Percentage of participants with Surgical Site Infection 4 weeks surgical site infection - necessitating antibiotic administration (diagnosed clinically or by wound swab)
5-level EQ-5D version (EQ-5D-5L) - Patient Quality of Life 12 months The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). This scale is a patient-reported outcome measure (PROM) designed to measure overall health status. The EQ-5D measures 5 health states measured from 1-5, with 1 being the best and 5 being the worst. An overall score can be generated from this with the best health at the minimum score of 5, and the worst health state at the maximum score of 25. The EQ VAS is an analogue scale from 0-100, with 100 being the best health and 0 being the worst health that you can imagine.