Recruiting

Pre-pectoral vs. Sub-pectoral

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT03959709

Conditions

Mastectomy

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

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

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

Study Details

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

Study ID

NCT03959709

Start date

Aug 22, 2019

Status verified date

Apr, 2022

Completion date

Dec 30, 2023

Anticipated

Primary completion date

Dec 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 20 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Prepectoral implant placement

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

active comparator: Subpectoral implant placement

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.

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.

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

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.

Primary outcome measure

  • Postoperative Pain and 24-hour narcotic consumption [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Jing Zhang, MD

(613) 798-5555jzhang1@toh.ca

Bahareh Ghaedi, MSc

(613) 798-5555bghaedi@ohri.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada

Principal Investigator:

Jing Zhang, MD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Apr 27, 2022

Last verified

Apr, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2022-04-27.