ciNPT in Autologous Abdominal Tissue Breast Reconstruction

Study Overview
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Brief Summary
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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

Official Title
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Closed Incision Negative Pressure Therapy Compared to Conventional Dressing Following Autologous Abdominal Tissue Breast Reconstruction: A Pilot Randomized Control Trial

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: DIEP Breast Reconstruction
* Device: ciNPT
* Other: Conventional Tape Dressings


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: patients who are pregnant have a documented/reported allergy to adhesive dressings

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ciNPT<br> | Procedure: DIEP Breast Reconstruction<br>* All patients enrolled in the study will undergo DIEP breast reconstruction and have their abdominal incision sutured according to routine clinical practice: 3-0 VICRYL ® suture (Ethicon, USA) for deep fascia closure, 4-0 MONOCRYL® suture (Ethicon, USA) for deep dermal closure, and 5-0 MONOCRYL® suture (Ethicon, USA) for subcuticular closure.<br>Device: ciNPT<br>* Following closure of the abdominal donor site, the closed incision will be dressed with the ciNPT system [V.A.C.ULTA™ Negative Pressure Wound Therapy System (KCI, USA)] applied by the operating surgeon in a sterile fashion. The ciNPT device will be set at -125mmHg of continuous negative pressure for a period of 7 days or until patient discharge from hospital. Removal of the ciNPT dressing will be performed by the surgical team at the time of discharge. Following removal, no additional dressings will be applied to the abdominal incision unless clinically indicated secondary to dehiscence.<br>|
| Active Comparator: Conventional tape dressings<br> | Procedure: DIEP Breast Reconstruction<br>* All patients enrolled in the study will undergo DIEP breast reconstruction and have their abdominal incision sutured according to routine clinical practice: 3-0 VICRYL ® suture (Ethicon, USA) for deep fascia closure, 4-0 MONOCRYL® suture (Ethicon, USA) for deep dermal closure, and 5-0 MONOCRYL® suture (Ethicon, USA) for subcuticular closure.<br>Other: Conventional Tape Dressings<br>* Following closure of the abdominal donor site, the closed abdominal incision will be dressed with 1-inch Micropore™ Surgical Tape (3M, USA) with an alcohol swab applied to the tape for additional adhesion, by the operating surgeon in a sterile fashion. This dressing will remain in-situ for up to 7 days or until patient discharge from hospital. Removal of the traditional tape dressing will be performed by the surgical team at the time of discharge. Following removal, no additional dressings will be applied unless clinically indicated secondary to dehiscence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patient Eligibility - Study Feasibility | 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. | 12 months | 
| Percentage of Patient Recruitment - Study Feasibility | 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. | 12 months | 
| Percentage of Patient Retention - Study Feasibility | 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with Abdominal Wall Dehiscence | 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 | 4 weeks | 
| Percentage of participants with Seroma Formation | seroma formation - defined by the presence of a symptomatic, subcutaneous fluid collection (diagnosed clinically or by ultrasound per clinician judgement) | 4 weeks | 
| Percentage of participants with Surgical Site Infection | surgical site infection - necessitating antibiotic administration (diagnosed clinically or by wound swab) | 4 weeks | 
| 5-level EQ-5D version (EQ-5D-5L) - Patient Quality of Life | 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. | 12 months | 
| BREAST-Q physical well-being abdomen - Patient Quality of Life | 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. | 12 months | 
| SCAR-Q - Patient Quality of Life | 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. | 12 months |