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Tissue Reinforcement of Incisional Closure Among High Risk Patients

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スポンサー
The University of Texas Health Science Center, Houston

キーワード

概要

Half of all individuals will undergo abdominal surgery in their lifetime. Following abdominal surgery, 30% of patients will suffer a major chronic complication with their wound closure in the first post-operative year. This may include significant wound infections, open wounds, fluid collections, fascial dehiscence, or incisional hernia. These complications not only have a substantial impact on the health care system (cost and chronic disease) and the hospital (cost and space), but most importantly have a substantial impact on the patient. Major chronic wound complications adversely impact patient quality of life and function. Potential methods to reduce major wound complications include utilizing specific suturing techniques or reinforcing the incision line. Suturing technique of small-bites (0.5x0.5 cm bites) as opposed to large bites (1.0x1.0 cm bites) has been shown to be efficacious in European populations with a typical body mass index of 20-25 kg/m2. Tissue reinforcement has been shown to decrease rates of major wound complications in small randomized controlled trials.
However, the lack of widespread adoption of these practices may be due to issues of generalizability including strict inclusion criteria, careful patient selection, and small study size. For example, the generalizability of small bites to an overweight population (mean BMI in the United States is 28 kg/m2) as opposed to a normal-weight population are unclear. The use of synthetic materials in comorbid patients or complex settings may risk major wound complications such as prosthetic infection. Biologic materials have been shown to be effective in decreasing major wound complications but in different settings. This study is being done to assess the effectiveness of different efficacious strategies to decrease the rate of major wound complications following abdominal surgery among high-risk individuals The researchers hypothesize:
1. Among high-risk patients undergoing abdominal surgery, the use of "small-bites" closure as opposed to "large-bites" closure will increase the proportion of patients who are free of major, chronic wound complications at 1-year post-operative.
2. Among high-risk patients undergoing abdominal surgery, the biologic tissue reinforcement of the suture line as opposed to no reinforcement will increase the proportion of patients who are free of major, chronic wound complications at 1-year post-operative.

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

Wound Complication

介入/治療

Device: Biologic Mesh

Procedure: Small Bytes

Procedure: Large Bytes

段階

-

アームグループ

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]

Proportion of patients with major chronic wound infection

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]

Defined by the CDC

2. Surgical site infections [1 month after surgery, 1 year after surgery, and 3 years after surgery]

Defined by the CDC

3. Reoperations [1 month after surgery, 1 year after surgery, and 3 years after surgery]

any unplanned invasive procedure involving the fascia, mesh, or peritoneal cavity

4. Operative duration [time of incision to end surgery time]

length of the entire procedure

5. Patient centered outcomes-Activities Assessment Scale [1 month after surgery, 1 year after surgery, and 3 years after surgery]

based upon the modified Activities Assessment Scale

6. Patient centered outcomes--Euroqol-5D [1 month after surgery, 1 year after surgery, and 3 years after surgery]

based upon the Euroqol-5D

7. Cost analyses [1 month after surgery, 1 year after surgery, and 3 years after surgery]

calculated from the hospital's perspective by assessing charges for all patient visits, admissions, and procedures

8. Surgeon perception [1 year after surgery, and 3 years after surgery]

likert type and open ended questions assessing perception, barriers and likelihood of utilizing interventions outside of the trial

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