Drain-Less Abdominally Based Breast Reconstruction Using Lysine-Derived Urethane Adhesive
2020年11月20日 更新者：Case Comprehensive Cancer Center
Drain-Less Abdominally Based Breast Reconstruction Using a Novel Lysine-Derived Urethane Adhesive (TissueGlu, Cohera Medical)
Drains are routinely utilized in breast reconstruction when using abdominal tissue of the patient to remove fluid buildup while the body heals after surgery. However, drains are associated with patient discomfort, anxiety, decreased mobility, increased hospital stays and outpatient visits. Drains can also serve as a site of origin for infection as the system is not completely closed, and infectious organisms could theoretically use the drain as point of entry.
This proposed study investigates a potential novel mechanism to prevent the development of seromas (pockets of clear fluid which can develop after surgery) in patients who undergo breast reconstruction with their own abdominal tissue. By eliminating the required use of a drain, the study team expects patients to have less pain and use less pain medication, as well as more satisfaction with their overall surgical experience.
調査の概要
詳細な説明
Objectives:
- Establish the safety of a lysine-derived urethane adhesive (TissuGlu, Cohera Medical) in patients undergoing autologous abdominal-based breast reconstruction. This will be assessed via analyzing complication profiles of patients post-operatively. The primary endpoints are rate of seroma development, need for seroma drainage and time to drain removal (if in drain group).
- Determine if there is a difference in pain and other quality of life measures when comparing patients who do and do not have abdominal drains. This will be assessed via pain medicine utilization and by delivering a targeted survey pre-operatively, as well as at post-operative day three and four weeks.
Study Design:
Patients will be randomized to one of three arms: 1) Traditional closed-suction drains, 2) TissuGlu with closed-suction drains and 3) TissuGlu without closed-suction drains.
研究の種類
介入
段階
- 適用できない
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
22年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
Patients undergoing Abdominally-Based Breast Reconstruction
- Both unilateral or bilateral reconstruction is allowed
- Both delayed or immediate reconstruction is allowed
Exclusion Criteria:
- Diabetes
- BMI>30
- Active smokers.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Tissue Glu with drains
This is standard of care to use Tissue Glu in addition to a drain.
Pre-operatively, as well as on post-operative patients will be asked to complete a questionnaire that addresses their pain, impact of drains on activities of daily living, social and physical activities.
Patients will also be asked to provide information regarding who is caring for the drains, the impact of drains on the caregiver, the amount of anxiety the patient has related to drain removal and the amount of pain associated with drain removal
|
Once adequate hemostasis has been achieved during surgery and the abdominal fascia and flaps have been irrigated, Tissue Glu will be applied.
Tissue Glu is applied at approximately one centimeter intervals while remaining one centimeter away from the umbilicus and inferior incisions.
他の名前：
Drains will be placed during surgery to allow for the drainage of seroma which may develop after surgery
他の名前：
Questionnaires given to patients pre-and post surgery to determine pain, impact of breast reconstruction on activity, and impact of breast reconstruction on caregivers
|
|
実験的：Tissue Glu without drains
This group utilizes Tissue Glu without the presence of a drain.
Pre-operatively, as well as on post-operative patients will be asked to complete a questionnaire that addresses their pain, impact of drains on activities of daily living, social and physical activities.
Patients will also be asked to provide information regarding who is caring for the drains, the impact of drains on the caregiver, the amount of anxiety the patient has related to drain removal and the amount of pain associated with drain removal
|
Once adequate hemostasis has been achieved during surgery and the abdominal fascia and flaps have been irrigated, Tissue Glu will be applied.
Tissue Glu is applied at approximately one centimeter intervals while remaining one centimeter away from the umbilicus and inferior incisions.
他の名前：
Questionnaires given to patients pre-and post surgery to determine pain, impact of breast reconstruction on activity, and impact of breast reconstruction on caregivers
|
|
アクティブコンパレータ：Drains
This is standard of care to use traditional closed-suction drains.
Pre-operatively, as well as on post-operative patients will be asked to complete a questionnaire that addresses their pain, impact of drains on activities of daily living, social and physical activities.
Patients will also be asked to provide information regarding who is caring for the drains, the impact of drains on the caregiver, the amount of anxiety the patient has related to drain removal and the amount of pain associated with drain removal
|
Drains will be placed during surgery to allow for the drainage of seroma which may develop after surgery
他の名前：
Questionnaires given to patients pre-and post surgery to determine pain, impact of breast reconstruction on activity, and impact of breast reconstruction on caregivers
|
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 |
|---|---|---|
|
Rate of seroma development
時間枠：Up to 30 days after surgery
|
Number of seromas which develop during the first 30 days after surgery.
|
Up to 30 days after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference in pain between patients with and without abdominal drains
時間枠：Up to 4 weeks after surgery
|
Patients will be given a questionnaire pre-operatively and the same questionnaire post-operatively.
The change in these questionnaires will be compared between groups
|
Up to 4 weeks after surgery
|
|
Pain Medicine Utilization
時間枠：Up to 4 weeks after surgery
|
Use of pain medicine after surgery between groups, as indicated by chart review
|
Up to 4 weeks after surgery
|
|
Time to drain removal
時間枠：Up to 4 weeks after surgery
|
Time from surgery to the removal of the drain for any reason, in patients who were given a drain
|
Up to 4 weeks after surgery
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Andrea Moreira, MD、Cleveland Clinic, Case Comprehensive Cancer Center
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (予想される)
2020年11月1日
一次修了 (予想される)
2021年2月1日
研究の完了 (予想される)
2021年9月1日
試験登録日
最初に提出
2017年5月17日
QC基準を満たした最初の提出物
2017年5月17日
最初の投稿 (実際)
2017年5月18日
学習記録の更新
投稿された最後の更新 (実際)
2020年11月24日
QC基準を満たした最後の更新が送信されました
2020年11月20日
最終確認日
2020年11月1日
詳しくは
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。
乳がんの臨床試験
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