Tissue Reinforcement of Incisional Closure Among High Risk Patients

Study Overview
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Brief Summary
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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: 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. 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.

Official Title
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Tissue Reinforcement of Incisional Closure Among High Risk Patients

Conditions
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Wound Complication

Intervention / Treatment
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* Device: Biologic Mesh
* Procedure: Small Bites
* Procedure: Large Bites


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All high-risk patients undergoing laparotomy or laparoscopic-assisted abdominal surgery. This includes: all overweight patients (BMI>=25 kg/m2), current smokers, those who are immunosuppressed, those who are malnourished, or those who are undergoing a contaminated case (CDC wound classification of 2 or 3). Exclusion Criteria: patients unlikely to follow-up in a year (e.g. no phone or lives out of state), patients unlikely to survive more than 2 years based upon surgeon judgment (e.g. metastatic cancer, end-stage cirrhosis), patients where the clinician would not place prosthetic (e.g. pregnant patient, pediatric patient during growth stage), patient has a planned second surgery within the next year (e.g. ostomy reversal).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biologic Mesh and Small Bites<br>Biologic mesh placement and small bites used for suturing. | Device: Biologic Mesh<br>* Biologic mesh placed during surgery<br>Procedure: Small Bites<br>* 0.5 cm x 0.5 cm sutures used<br>|
| Experimental: Small Bites and No Biologic Mesh<br>Small bites used for suturing with no placement of biologic mesh | Procedure: Small Bites<br>* 0.5 cm x 0.5 cm sutures used<br>|
| Experimental: Biologic mesh and Large Bites<br>Biologic mesh placement and large bites used for suturing | Device: Biologic Mesh<br>* Biologic mesh placed during surgery<br>Procedure: Large Bites<br>* 1.0 x 1.0 sutures used<br>|
| Active Comparator: Large Bites and no biologic mesh<br>Large bites used for suturing and no placement of biologic mesh. | Procedure: Large Bites<br>* 1.0 x 1.0 sutures used<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Major Chronic Wound Infection | Proportion of participants with major chronic wound infection | 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Major Complications | Major complications include surgical site infection, ventral incisional hernia, and/or reoperation | 1 year after surgery | 
| Number of Participants With Surgical Site Infections |  | 1 year after surgery | 
| Number of Participants With Reoperations | any unplanned invasive procedure involving the fascia, mesh, or peritoneal cavity | 1 year after surgery | 
| Operative Duration | length of the entire procedure | about 119 minutes to 337 minutes | 
| Participants Quality of Life as Assessed by Activities Assessment Scale | Quality of life is scored from 1 to 100, where the higher the score the higher quality of life | 1 year after surgery | 
| Participants Health Status as Assessed by the Euroqol-5D Questionnaire | Health Status is scored from 0 to 100, where the higher the score the better the health | 1 year after surgery | 
| Cost Analyses | calculated from the hospital's perspective by assessing charges for all patient visits, admissions, and procedures | 1 year after surgery | 
| Surgeon Perception | likert type and open ended questions assessing perception, barriers and likelihood of utilizing interventions outside of the trial | 1 year after surgery | 
| Number of Participants With Major Complications | Major complications include surgical site infection, ventral incisional hernia, and/or reoperation | 3 years after surgery | 
| Number of Participants With Surgical Site Infections |  | 3 years after surgery | 
| Number of Participants With Reoperations | any unplanned invasive procedure involving the fascia, mesh, or peritoneal cavity | 3 years after surgery | 
| Participants Quality of Life as Assessed by Activities Assessment Scale | Quality of life is scored from 1 to 100, where the higher the score the higher quality of life | 3 years after surgery | 
| Participants Health Status as Assessed by the Euroqol-5D Questionnaire | Health Status is scored from 0 to 100, where the higher the score the better the health | 3 years after surgery | 
| Cost Analyses | calculated from the hospital's perspective by assessing charges for all patient visits, admissions, and procedures | 3 years after surgery | 
| Surgeon Perception | likert type and open ended questions assessing perception, barriers and likelihood of utilizing interventions outside of the trial | 3 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominal surgery, wound complication