Direct-to-Implant Extracellular Matrix Hammock-based Breast Reconstruction; Prepectoral or Subpectoral?
Abstract Background Skin-sparing mastectomy followed by immediate implant-based breast reconstruction is a commonly used treatment for breast cancer. However, when placing the implant in a subpectoral pocket, a high incidence of breast animation deformity (BAD) has been reported. Besides the nuisanc...
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doaj-dd2824e335d04646b6f751ccc37582392021-02-14T12:30:34ZengBMCTrials1745-62152020-02-012111710.1186/s13063-020-4125-6Direct-to-Implant Extracellular Matrix Hammock-based Breast Reconstruction; Prepectoral or Subpectoral?Diana L. Dyrberg0Gudjon L. Gunnarsson1Camilla Bille2Jens A. Sørensen3Jørn B. Thomsen4Department of Plastic Surgery, Odense University Hospital, Odense/ Lillebaelt HospitalDepartment of Plastic Surgery, Telemark HospitalDepartment of Plastic Surgery, Odense University HospitalDepartment of Plastic Surgery, Odense University HospitalDepartment of Plastic Surgery, Odense University Hospital, Odense/ Lillebaelt HospitalAbstract Background Skin-sparing mastectomy followed by immediate implant-based breast reconstruction is a commonly used treatment for breast cancer. However, when placing the implant in a subpectoral pocket, a high incidence of breast animation deformity (BAD) has been reported. Besides the nuisance that BAD can cause, lifting of the pectoralis major muscle (PMM) can result in a more extended postoperative recovery period. When placing the implant solely prepectorally leaving the PMM undisturbed, the incidence and severity of BAD might be mitigated. However, new challenges may occur because of thinner skin cover. Methods/design A prospective, multi-centre, randomised controlled trial will be carried out with the primary aim of assessing and comparing the incidence and degree of BAD in women having a direct-to-implant breast reconstruction with either a prepectorally or a subpectorally placed implant. The secondary outcomes are shoulder and arm function, quality of life, aesthetic evaluation, length of stay, complications, need for surgical corrections, and development of capsular contracture. A total of 70 included patients will be followed under admittance and at clinical check-ups 3 months and 1 year after surgery. Discussion To our knowledge, this trial is the first randomised controlled trial evaluating and comparing subpectoral and prepectoral implant placement when performing direct-to-implant breast reconstruction following skin-sparing mastectomy. The results will hopefully provide us with a broader knowledge of the outcomes of immediate breast reconstruction, making better preoperative planning possible in the future by providing our patients with a more objective information. Trial registration ClinicalTrials.gov, ID: NCT03143335. Prospectively registered on 8 May 2017.https://doi.org/10.1186/s13063-020-4125-6Breast animation deformityImmediate breast reconstructionBreast implantsSubpectoral implant placementPrepectoral implant placement |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Diana L. Dyrberg Gudjon L. Gunnarsson Camilla Bille Jens A. Sørensen Jørn B. Thomsen |
spellingShingle |
Diana L. Dyrberg Gudjon L. Gunnarsson Camilla Bille Jens A. Sørensen Jørn B. Thomsen Direct-to-Implant Extracellular Matrix Hammock-based Breast Reconstruction; Prepectoral or Subpectoral? Trials Breast animation deformity Immediate breast reconstruction Breast implants Subpectoral implant placement Prepectoral implant placement |
author_facet |
Diana L. Dyrberg Gudjon L. Gunnarsson Camilla Bille Jens A. Sørensen Jørn B. Thomsen |
author_sort |
Diana L. Dyrberg |
title |
Direct-to-Implant Extracellular Matrix Hammock-based Breast Reconstruction; Prepectoral or Subpectoral? |
title_short |
Direct-to-Implant Extracellular Matrix Hammock-based Breast Reconstruction; Prepectoral or Subpectoral? |
title_full |
Direct-to-Implant Extracellular Matrix Hammock-based Breast Reconstruction; Prepectoral or Subpectoral? |
title_fullStr |
Direct-to-Implant Extracellular Matrix Hammock-based Breast Reconstruction; Prepectoral or Subpectoral? |
title_full_unstemmed |
Direct-to-Implant Extracellular Matrix Hammock-based Breast Reconstruction; Prepectoral or Subpectoral? |
title_sort |
direct-to-implant extracellular matrix hammock-based breast reconstruction; prepectoral or subpectoral? |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2020-02-01 |
description |
Abstract Background Skin-sparing mastectomy followed by immediate implant-based breast reconstruction is a commonly used treatment for breast cancer. However, when placing the implant in a subpectoral pocket, a high incidence of breast animation deformity (BAD) has been reported. Besides the nuisance that BAD can cause, lifting of the pectoralis major muscle (PMM) can result in a more extended postoperative recovery period. When placing the implant solely prepectorally leaving the PMM undisturbed, the incidence and severity of BAD might be mitigated. However, new challenges may occur because of thinner skin cover. Methods/design A prospective, multi-centre, randomised controlled trial will be carried out with the primary aim of assessing and comparing the incidence and degree of BAD in women having a direct-to-implant breast reconstruction with either a prepectorally or a subpectorally placed implant. The secondary outcomes are shoulder and arm function, quality of life, aesthetic evaluation, length of stay, complications, need for surgical corrections, and development of capsular contracture. A total of 70 included patients will be followed under admittance and at clinical check-ups 3 months and 1 year after surgery. Discussion To our knowledge, this trial is the first randomised controlled trial evaluating and comparing subpectoral and prepectoral implant placement when performing direct-to-implant breast reconstruction following skin-sparing mastectomy. The results will hopefully provide us with a broader knowledge of the outcomes of immediate breast reconstruction, making better preoperative planning possible in the future by providing our patients with a more objective information. Trial registration ClinicalTrials.gov, ID: NCT03143335. Prospectively registered on 8 May 2017. |
topic |
Breast animation deformity Immediate breast reconstruction Breast implants Subpectoral implant placement Prepectoral implant placement |
url |
https://doi.org/10.1186/s13063-020-4125-6 |
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