ciNPT in Autologous DIEP Flap Breast Reconstruction

NCT05907941 | Not Yet Recruiting FDA Device

• 1 other identifier: 16422
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Wound Dehiscence, Surgical

Outcome Measures

Primary Outcomes (1)

• 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

  one measurement between 4-8 weeks (variable based on surgeons' routine follow up)

Secondary Outcomes (7)

• Percentage of participants with Seroma Formation

  2 weeks, 4-8 weeks (variable based on surgeons' routine follow up)

• Percentage of participants with Surgical Site Infection

  2 weeks, 4-8 weeks (variable based on surgeons' routine follow up)

• 5-level EQ-5D version (EQ-5D-5L) - Patient Quality of Life

  1 month, 3 month, 6 months

• EQ-VAS

  1 month, 3 month, 6 months

• BREAST-Q physical well-being abdomen - Patient Quality of Life

  1 month, 3 month, 6 months

Study Arms (2)

ciNPT

EXPERIMENTAL

Device: ciNPT; Procedure: DIEP Breast Reconstruction

Conventional tape dressings

ACTIVE COMPARATOR

Other: Conventional Tape Dressings; Procedure: DIEP Breast Reconstruction

Interventions

ciNPT DEVICE

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.

ciNPT

Conventional Tape Dressings OTHER

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.

Conventional tape dressings

DIEP Breast Reconstruction PROCEDURE

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.

Conventional tape dressings; ciNPT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead
• Western University: collaborator

Related Publications (23)

• 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.

  PMID: 29369109 BACKGROUND

• Chang EI, Liu J. Prospective Evaluation of Obese Patients Undergoing Autologous Abdominal Free Flap Breast Reconstruction. Plast Reconstr Surg. 2018 Aug;142(2):120e-125e. doi: 10.1097/PRS.0000000000004550.

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• Muller-Sloof E, de Laat HEW, Hummelink SLM, Peters JWB, Ulrich DJO. The effect of postoperative closed incision negative pressure therapy on the incidence of donor site wound dehiscence in breast reconstruction patients: DEhiscence PREvention Study (DEPRES), pilot randomized controlled trial. J Tissue Viability. 2018 Nov;27(4):262-266. doi: 10.1016/j.jtv.2018.08.005. Epub 2018 Aug 14.

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• Lindenblatt N, Gruenherz L, Farhadi J. A systematic review of donor site aesthetic and complications after deep inferior epigastric perforator flap breast reconstruction. Gland Surg. 2019 Aug;8(4):389-398. doi: 10.21037/gs.2019.06.05.

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• World Union of Wound Healing Societies (WUWHS) Consensus Document. Surgical wound dehiscence: improving prevention and outcomes. Wounds International2018.

  BACKGROUND

• Thacoor A, Kanapathy M, Torres-Grau J, Chana J. Deep inferior epigastric perforator (DIEP) flap: Impact of drain free donor abdominal site on long term patient outcomes and duration of inpatient stay. J Plast Reconstr Aesthet Surg. 2018 Aug;71(8):1103-1107. doi: 10.1016/j.bjps.2018.04.019. Epub 2018 May 22.

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• Siegwart LC, Sieber L, Fischer S, Maraka S, Kneser U, Kotsougiani-Fischer D. Influence of closed incision negative-pressure therapy on abdominal donor-site morbidity in microsurgical breast reconstruction. Microsurgery. 2022 Jan;42(1):32-39. doi: 10.1002/micr.30683. Epub 2020 Nov 17.

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  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Surgical Wound Dehiscence

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christopher J Coroneos, MD MSc FRCSC

CONTACT

905-521-2100; coronec@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 18, 2023
• Study Start: July 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: March 1, 2026
• Last Updated: March 15, 2024

Record last verified: 2024-03