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ciNPT in Autologous DIEP Flap Breast Reconstruction

Primary Purpose

Breast Cancer, Wound Dehiscence, Surgical

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ciNPT
Conventional Tape Dressings
DIEP Breast Reconstruction
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 Body mass index (BMI) ≥ 40 kg/m2

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ciNPT

    Conventional tape dressings

    Arm Description

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Percentage of participants with Seroma Formation
    defined by the presence of a symptomatic, subcutaneous fluid collection (diagnosed clinically or by ultrasound per clinician judgement)
    Percentage of participants with Surgical Site Infection
    necessitating antibiotic administration (diagnosed clinically or by wound swab)
    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
    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.
    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.
    Incidence of myocardial injury after non-cardiac surgery (MINS)
    MINS is defined by the presence of abnormally elevated postoperative high-sensitivity troponin T (hsTnT) levels within the first 3 days after surgery

    Full Information

    First Posted
    June 8, 2023
    Last Updated
    June 8, 2023
    Sponsor
    McMaster University
    Collaborators
    Western University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05907941
    Brief Title
    ciNPT in Autologous DIEP Flap Breast Reconstruction
    Official Title
    Closed Incision Negative Pressure Therapy Compared to Conventional Dressing Following Autologous Abdominal Tissue Breast Reconstruction: A Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    September 2025 (Anticipated)
    Study Completion Date
    March 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    McMaster University
    Collaborators
    Western University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    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 our academic institution, patients who undergo DIEP breast reconstruction typically have 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. We propose a randomized controlled superiority trial with the primary objective of comparing the incidence of wound dehiscence at 1 month in patients undergoing autologous DIEP breast reconstruction with ciNPT versus standard tape dressings for the abdominal donor site incision. The design and conduct of the proposed study will mirror the methodology of the recently completed pilot trial (NCT04985552) including randomization, interventions, and clinical outcomes. The secondary objective of this study is to evaluate other clinical outcomes comparing ciNPT to standard tape dressings applied to the abdominal donor site incision. Secondary clinical outcomes will include: 2) the incidence of seroma formation and surgical site infection at 1 month; 2) quality of life as measured by BREAST-Q physical well-being abdomen and EQ-5D-5L pre-operatively, 1-month, 3-months, and 6-months postoperatively; 3) Scar appearance as measured by the SCAR-Q at 1-month, 3-months, and 6-months postoperatively. As an adjunct to the main study, another secondary clinical outcome will include the overall incidence of MINS as diagnosed by postoperative abnormally elevated troponin levels (as per site-specific laboratory assay thresholds) and electrocardiograms (ECG) at 6-12 hours and 1, 2, and 3 days after surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Wound Dehiscence, Surgical

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    114 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ciNPT
    Arm Type
    Experimental
    Arm Title
    Conventional tape dressings
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    ciNPT
    Intervention Description
    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 (Figure 2). 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.
    Intervention Type
    Other
    Intervention Name(s)
    Conventional Tape Dressings
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    DIEP Breast Reconstruction
    Intervention Description
    All patients enrolled in the study will undergo DIEP breast reconstruction and have their abdominal incision sutured according to routine clinical practice. At the Hamilton sites, we will use 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. At the London sites, we will use 2-0 VICRYL ® suture (Ethicon, USA) for deep fascia closure, 3-0 MONOCRYL® suture (Ethicon, USA) for deep dermal closure, and 4-0 MONOCRYL® suture (Ethicon, USA) for subcuticular closure.
    Primary Outcome Measure Information:
    Title
    Percentage of participants with Abdominal Wall Dehiscence
    Description
    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
    Time Frame
    4-8 weeks
    Secondary Outcome Measure Information:
    Title
    Percentage of participants with Seroma Formation
    Description
    defined by the presence of a symptomatic, subcutaneous fluid collection (diagnosed clinically or by ultrasound per clinician judgement)
    Time Frame
    2 weeks, 4-8 weeks
    Title
    Percentage of participants with Surgical Site Infection
    Description
    necessitating antibiotic administration (diagnosed clinically or by wound swab)
    Time Frame
    2 weeks, 4-8 weeks
    Title
    5-level EQ-5D version (EQ-5D-5L) - Patient Quality of Life
    Description
    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
    Time Frame
    1 month, 3 month, 6 months
    Title
    BREAST-Q physical well-being abdomen - Patient Quality of Life
    Description
    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.
    Time Frame
    1 month, 3 month, 6 months
    Title
    SCAR-Q - Patient Quality of Life
    Description
    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.
    Time Frame
    1 month, 3 month, 6 months
    Title
    Incidence of myocardial injury after non-cardiac surgery (MINS)
    Description
    MINS is defined by the presence of abnormally elevated postoperative high-sensitivity troponin T (hsTnT) levels within the first 3 days after surgery
    Time Frame
    6-12 hours, 1 day, 2 days, 3 days

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 Body mass index (BMI) ≥ 40 kg/m2
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christopher J Coroneos, MD MSc FRCSC
    Phone
    905-521-2100
    Ext
    44369
    Email
    coronec@mcmaster.ca

    12. IPD Sharing Statement

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