ciNPT in Autologous DIEP Flap Breast Reconstruction

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer; Wound Dehiscence, Surgical
• Interventions: Device: ciNPT; Other: Conventional Tape Dressings; Procedure: DIEP Breast Reconstruction

• Registration Number: NCT05907941
• 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-08
• Study First Submitted QC: 2023-06-08
• Study First Posted: 2023-06-18
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15
• Study Start: 2024-07
• Primary Completion: 2025-09
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 114

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

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Exclusion Criteria

• patients who are pregnant
• have a documented/reported allergy to adhesive dressings
• Body mass index (BMI) ≥ 40 kg/m2

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ciNPT	ciNPT	-
ciNPT	DIEP Breast Reconstruction	-
Conventional tape dressings	Conventional Tape Dressings	-
Conventional tape dressings	DIEP Breast Reconstruction	-

Primary Outcome Measures

Name	Time	Method
Percentage of participants with Abdominal Wall Dehiscence	one measurement between 4-8 weeks (variable based on surgeons' routine follow up)	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

Name	Time	Method
Percentage of participants with Seroma Formation	2 weeks, 4-8 weeks (variable based on surgeons' routine follow up)	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	2 weeks, 4-8 weeks (variable based on surgeons' routine follow up)	necessitating antibiotic administration (diagnosed clinically or by wound swab)
5-level EQ-5D version (EQ-5D-5L) - Patient Quality of Life	1 month, 3 month, 6 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.
SCAR-Q - Patient Quality of Life	1 month, 3 month, 6 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.
EQ-VAS	1 month, 3 month, 6 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 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	1 month, 3 month, 6 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.
Incidence of myocardial injury after non-cardiac surgery (MINS)	6-12 hours, 1 day, 2 days, 3 days	MINS is defined by the presence of abnormally elevated postoperative high-sensitivity troponin T (hsTnT) levels within the first 3 days after surgery