Clinical trial NCT04985552: ciNPT in Autologous Abdominal Tissue Breast Reconstruction
Official title: Closed Incision Negative Pressure Therapy Compared to Conventional Dressing Following Autologous Abdominal Tissue Breast Reconstruction: A Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
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 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


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

Primary outcomes:
measure: Percentage of Patient Eligibility - Study Feasibility
timeFrame: 12 months
measure: Percentage of Patient Recruitment - Study Feasibility
timeFrame: 12 months
measure: Percentage of Patient Retention - Study Feasibility
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of participants with Abdominal Wall Dehiscence
timeFrame: 4 weeks
measure: Percentage of participants with Seroma Formation
timeFrame: 4 weeks
measure: Percentage of participants with Surgical Site Infection
timeFrame: 4 weeks
measure: 5-level EQ-5D version (EQ-5D-5L) - Patient Quality of Life
timeFrame: 12 months
measure: BREAST-Q physical well-being abdomen - Patient Quality of Life
timeFrame: 12 months
measure: SCAR-Q - Patient Quality of Life
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Leyngold MM. Is Unipedicled Transverse Rectus Abdominis Myocutaneous Flap Obsolete Owing to Superiority of DIEP Flap? Ann Plast Surg. 2018 Jun;80(6S Suppl 6):S418-S420. doi: 10.1097/SAP.0000000000001319.
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