Pre-pectoral Versus Sub-pectoral Implant Placement in Immediate Breast Reconstruction

NCT03959709 | Unknown DMC

• 1 other identifier: 1449
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the popularity and proved safety of prepectoral implant-based reconstruction, there is little evidence on long-term results and variables which could influence surgical outcome. So far, no specific guidelines or indications have been developed for prepectoral technique and heterogeneous inclusion criteria had been used in previous reports. There is a lack of studies documenting outcomes following ADM-assisted prepectoral breast reconstruction, and there are no randomised controlled trial studies that drawing a direct comparison of clinical or patient-reported outcomes between subpectoral and prepectoral groups. The investigators hypothesized that immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement would result in less early postoperative pain but more reported implant rippling, requirement of more fat grafting and an equitable safety profile compared with ADM-assisted implant-based breast reconstruction with subpectoral implant placement. The aim of this study is to evaluate the postsurgical pain, complications and patient-reported outcomes of prepectoral breast reconstruction versus subpectoral implant placement in immediate breast reconstruction.

Conditions

Mastectomy; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain and 24-hour narcotic consumption

  Postoperative Pain will be scored using Numerical rating scale. The scale ranges from 0 to 10 indicating the level of pain. Zero indicates the absence of pain, while 10 represents the most intense pain (no pain = 0, mild = 1-3, moderate = 4-6, severe = 7-10).

  24 hours

Secondary Outcomes (9)

• Mastectomy flap necrosis

  4 weeks

• Rate of seroma

  4 weeks

• Rate of infection

  3 months

• Rate of Explantation

  1 year

• Number of Revisional surgeries

  1 year

Study Arms (2)

Prepectoral implant placement

EXPERIMENTAL

Immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement.

Procedure: immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement.

Subpectoral implant placement

ACTIVE COMPARATOR

Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement.

Procedure: Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement

Interventions

immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement. PROCEDURE

On the day of surgery, after the completion of the mastectomy, the vascularity of the mastectomy flaps will be evaluated, and debridement is performed where necessary. A temporary implant sizer is placed in the pocket to assess the position and shape of the prepectoral pocket. The pocket is adjusted where necessary. A sheet of ADM (DermAcell) is then selected. The DermAcell will be prepared as per the manufacture's instructions and fenestrated using size 11 blade. The DermACELL piece will be trimmed to the appropriate shape and sutured to the superior medial and lateral edges of the pectoralis major muscle. The inferior edge will be sutured to the fascia at the level of the inframammary fold. Two closed suction drains will be placed (one below the mastectomy skin flap, and one below DermACELL). The implant will be inserted to the pre-pectoral pocket and several anchor sutures will be used to secure the superior-medial edge of DermACELL to mastectomy flap.

Prepectoral implant placement

Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement PROCEDURE

On the day of surgery, after the completion of the mastectomy, the vascularity of the mastectomy flaps will be evaluated, and debridement is performed where necessary. The reconstructive operative procedure will then proceeded with (1) elevation of the pectoralis major muscle with release of inferior attachments; (2) placement of implant subpectorally; (3) placement and suturing of DermACELL to constitute the inferolateral breast pocket; (4) placement of two closed suction drains (one superiorly between the pectoralis major and skin, and one inferiorly between the DermACELL and skin); (5) removal of sizer and placement of permanent to the pocket and (6) suture the inferior edge of DermACELL to the inferior edge of the pectoral major muscle. The skin will be closed and the dressing will be applied as standard protocol.

Subpectoral implant placement

Eligibility Criteria

• Age: 20 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patient
• Ages 20-80
• All patients undergoing mastectomy for breast cancer or prophylaxis for breast cancer with immediate implant-based reconstruction
• Able to provide informed consent

You may not qualify if:

• Patients who have had prior chest wall or irradiation on the reconstructed side
• Patients not undergoing immediate breast reconstruction at the time of mastectomy
• Any patient with a contraindication to immediate breast reconstruction.
• Patients with history of smoking, BMI\> 40, and D cup breast size or grade III ptosis are all contraindications to immediate breast reconstruction as the risk of postoperative complications are significantly higher (wound infection, dehiscence, implant loss, seroma) than the average patient and thus these patients would be excluded from the study.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jing Zhang, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Zhang, MD

CONTACT

(613) 798-5555; jzhang1@toh.ca

Bahareh Ghaedi, MSc

CONTACT

(613) 798-5555; bghaedi@ohri.ca

Study Design

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

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 22, 2019
• Study Start: August 22, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2023
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)