豊胸手術のための局所抗生物質 (BREAST-AB)
乳房再建手術を受ける女性のためのゲンタマイシン、バンコマイシン、およびセファゾリン抗生物質の溶液による乳房インプラントの予防的治療：ランダム化比較試験（BREAST-AB試験）
The BREAST-AB Trial is a multi-center, randomized, double blind, placebo-controlled trial investigating the efficacy of local application of gentamicin, vancomycin and cefazolin in decreasing all-cause implant explantation after breast reconstruction.
調査の概要
状態
詳細な説明
The BREAST-AB Trial will include women undergoing breast reconstruction with implants. The objective is to determine the efficacy of local antibiotics in decreasing all-cause implant explantation. Participants will be randomized to local application of placebo or gentamicin, vancomycin and cefazolin in a saline solution onto the implant and the dissected breast pocket. All patients undergoing unilateral breast reconstruction will be randomized to the trial drug or placebo in a ratio of 1:1. All patients undergoing bilateral reconstruction will be randomized to the trial treatment on one of their breasts and placebo to the contralateral breast. A total number of 1274 of breasts undergoing breast reconstruction will be included in the trial.
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
-
Aalborg、デンマーク、9000
- Aalborg University Hospital
-
Aarhus、デンマーク、8000
- Aarhus University Hospital
-
Copenhagen、デンマーク、2100
- Rigshospitalet
-
Esbjerg、デンマーク、6700
- South-West Jutland Hospital
-
Herlev、デンマーク、2730
- Herlev and Gentofte Hospital
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Odense、デンマーク、5000
- Odense University Hospital
-
Roskilde、デンマーク、4000
- Zealand University Hospital
-
Vejle、デンマーク、7100
- Vejle Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
-
Age ≥ 18 years
-
Biologically female
-
Signed informed consent
-
Scheduled for breast reconstruction with implants or expanders including:
- Immediate or delayed reconstructions
- Bilateral or unilateral reconstructions
- With or without simultaneous flap reconstruction
Exclusion Criteria:
- Pregnancy
- Breast feeding
- Known allergy towards Vancomycin, Gentamicin and Cefazolin
- Known anaphylactic reaction towards other beta-lactam antibiotics or aminoglycosides
- Known allergy towards neomycin
- Known impaired renal function with GFR < 60 mL/min
- Participation in investigational drug trials and projects concerning disinfecting agents in the breast implant cavity
- Myasthenia Gravis
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：Irrigation of implants with sterile isotonic saline
The placebo solution will consist of 500 mL of sterile isotonic (9%) saline contained in a infusion bag. |
500 mL of sterile isotonic (9%) saline. The solution will be used to wash the dissected implant pocket and the implant prior to insertion in the implant pocket.
他の名前：
|
|
実験的：Irrigation of implants with a triple antibiotic solution
The antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in 500 mL sterile isotonic (9%) saline |
The antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in a 500 mL isotonic saline solution. The solution will be used to wash the dissected implant pocket and the implant prior to insertion in the implant pocket.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
All-cause explantation of the breast implant after the breast reconstruction surgery
時間枠：180 days
|
All-cause explantation will be defined as explantation and discarding of the implant. Replacement of an expander with a permanent implant and replacement of a permanent breast implant with a new permanent breast implant due to cosmetic revisions such as asymmetry, implant malposition, change of size or implant rotation will not be counted as an explantation. |
180 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to explantation (days)
時間枠：180 days
|
Time to explantation will be defined as the amount of days between the breast reconstruction and the implant explantation surgery. |
180 days
|
|
Revision surgery with incision of the fibrous capsule after the breast reconstruction surgery (Y/N)
時間枠：180 days
|
The breast reconstruction surgery will be defined as the surgery where they received the allocated treatment |
180 days
|
|
Exchange of permanent implant to expander implant after the breast reconstruction surgery (Y/N)
時間枠：180 days
|
The breast reconstruction surgery will be defined as the surgery where they received the allocated treatment |
180 days
|
|
Surgical site infection that leads to antibiotic treatment after the breast reconstruction surgery
時間枠：180 days
|
Surgical site infection will be defined according to the CDC classification of surgical site infetion leading to antibiotic treatment with oral or intravenous antibiotics administered after the surgery. |
180 days
|
|
All-cause explantation of the breast implant within 1 year after the breast reconstruction surgery
時間枠：1 year
|
All-cause explantation will be defined as explantation and discarding of the implant. Replacement of an expander with a permanent implant and replacement of a permanent breast implant with a new permanent breast implant due to cosmetic revisions such as asymmetry, implant malposition, change of size or implant rotation will not be counted as an explantation. |
1 year
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time from the breast reconstruction surgery to discharge (days)
時間枠：180 days
|
Time to discharge will be defined as the amount of days between the breast reconstruction and the day of discharge. |
180 days
|
|
Re-admission after the breast reconstruction surgery (Y/N)
時間枠：180 days
|
The breast reconstruction surgery will be defined as the surgery where the patient received the allocated treatment. |
180 days
|
|
Long term follow-up after 5, 10 and 15 years
時間枠：15 years
|
Capsular contracture and the Baker classification grade will be obtained from the National Patient Registry and the patients' medical journals after 5, 10 and 15 years. The BREAST-Q questionnaire will be used to assess patient-reported outcomes. The patients will be contacted and asked to fill out the questionnaire with 5 year-intervals after the surgery. |
15 years
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Mikkel Herly, MD, Ph.D.、Department of Plastic Surgery and Burns Treatment
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- BREAST-AB-01
- 2020-002459-40 (EudraCT番号)
- 0058322 (その他の助成金/資金番号：Novo Nordisk Foundation)
- R-189- A4127 (その他の助成金/資金番号：Medicine Fund of the Danish Regions)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
The protocol including the statistical analysis plan is published in BMJ Open (doi:10.1136/bmjopen-2021-058697) prior to unblinding. The main article will include the primary and secondary outcomes. The tertiary and long-term outcomes will be included in subsequent articles. The manuscripts will be submitted to peer-reviewed international journals and both positive, negative and inconclusive results will be published. The findings of the trial will be shared with participating sites and presented at national and international conferences. The results will be disseminated to the public but will not be shared directly with participating patients.
IPD 共有時間枠
After the end of the trial, the data will become available (Anticipated july 2025)
IPD 共有アクセス基準
Researchers and other relevant parties can be granted access to selected anonymized data after publication upon request to the principal-sponsor investigator
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。