Clinical trial NCT05907941: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Wound Dehiscence, Surgical
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Western University
First posted: 2023-06-18
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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.


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

Primary outcomes:
measure: Percentage of participants with Abdominal Wall Dehiscence
timeFrame: one measurement between 4-8 weeks (variable based on surgeons' routine follow up)
Secondary outcomes:
measure: Percentage of participants with Seroma Formation
timeFrame: 2 weeks, 4-8 weeks (variable based on surgeons' routine follow up)
measure: Percentage of participants with Surgical Site Infection
timeFrame: 2 weeks, 4-8 weeks (variable based on surgeons' routine follow up)
measure: 5-level EQ-5D version (EQ-5D-5L) - Patient Quality of Life
timeFrame: 1 month, 3 month, 6 months
measure: EQ-VAS
timeFrame: 1 month, 3 month, 6 months
measure: BREAST-Q physical well-being abdomen - Patient Quality of Life
timeFrame: 1 month, 3 month, 6 months
measure: SCAR-Q - Patient Quality of Life
timeFrame: 1 month, 3 month, 6 months
measure: Incidence of myocardial injury after non-cardiac surgery (MINS)
timeFrame: 6-12 hours, 1 day, 2 days, 3 days
Other outcomes:
Locations:
Study officials:
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