Tissue Reinforcement of Incisional Closure Among High Risk Patients
キーワード
概要
日付
最終確認済み: | 03/31/2020 |
最初に提出された: | 05/04/2017 |
提出された推定登録数: | 05/07/2017 |
最初の投稿: | 05/10/2017 |
最終更新が送信されました: | 04/09/2020 |
最終更新日: | 04/12/2020 |
実際の研究開始日: | 09/12/2017 |
一次完了予定日: | 11/30/2020 |
研究完了予定日: | 11/30/2022 |
状態または病気
介入/治療
Device: Biologic Mesh
Procedure: Small Bytes
Procedure: Large Bytes
段階
アームグループ
腕 | 介入/治療 |
---|---|
Experimental: Biologic Mesh and Small Bytes Biologic mesh placement and small bytes used for suturing. | |
Experimental: Small Bytes and No Biologic Mesh Small bytes used for suturing with no placement of biologic mesh | |
Experimental: Biologic mesh and Large Bytes Biologic mesh placement and large bytes used for suturing | |
Active Comparator: Large Bytes and no biologic mesh Large bytes used for suturing and no placement of biologic mesh. |
適格基準
研究の対象となる年齢 | 18 Years に 18 Years |
研究に適格な性別 | All |
健康なボランティアを受け入れる | はい |
基準 | Inclusion Criteria: All high-risk patients undergoing laparotomy or laparoscopic-assisted abdominal surgery. This includes: 1. all overweight patients (BMI>=25 kg/m2), 2. current smokers, 3. those who are immunosuppressed, 4. those who are malnourished, or 5. those who are undergoing a contaminated case (CDC wound classification of 2 or 3). Exclusion Criteria: 1. patients unlikely to follow-up in a year (e.g. no phone or lives out of state), 2. patients unlikely to survive more than 2 years based upon surgeon judgment (e.g. metastatic cancer, end-stage cirrhosis), 3. patients where the clinician would not place prosthetic (e.g. pregnant patient, pediatric patient during growth stage), 4. patient has a planned second surgery within the next year (e.g. ostomy reversal). |
結果
主な結果の測定
1. Major Chronic Wound Infection [1 year after surgery]
二次的な結果の測定
1. Dindo-Clavien complications [1 month after surgery, 1 year after surgery, and 3 years after surgery]
2. Surgical site infections [1 month after surgery, 1 year after surgery, and 3 years after surgery]
3. Reoperations [1 month after surgery, 1 year after surgery, and 3 years after surgery]
4. Operative duration [time of incision to end surgery time]
5. Patient centered outcomes-Activities Assessment Scale [1 month after surgery, 1 year after surgery, and 3 years after surgery]
6. Patient centered outcomes--Euroqol-5D [1 month after surgery, 1 year after surgery, and 3 years after surgery]
7. Cost analyses [1 month after surgery, 1 year after surgery, and 3 years after surgery]
8. Surgeon perception [1 year after surgery, and 3 years after surgery]