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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
163
Biologic mesh placed during surgery
0.5 cm x 0.5 cm sutures used
1.0 x 1.0 sutures used
Lyndon B. Johnson (LBJ) Hospital
Houston, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Proportion of Participants Major Chronic Wound Infection
Proportion of participants with major chronic wound infection
Time frame: 1 year after surgery
Number of Participants With Major Complications
Major complications include surgical site infection, ventral incisional hernia, and/or reoperation
Time frame: 1 year after surgery
Number of Participants With Surgical Site Infections
Time frame: 1 year after surgery
Number of Participants With Reoperations
any unplanned invasive procedure involving the fascia, mesh, or peritoneal cavity
Time frame: 1 year after surgery
Operative Duration
length of the entire procedure
Time frame: 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
Time frame: 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
Time frame: 1 year after surgery
Cost Analyses
calculated from the hospital's perspective by assessing charges for all patient visits, admissions, and procedures
Time frame: 1 year after surgery
Surgeon Perception
likert type and open ended questions assessing perception, barriers and likelihood of utilizing interventions outside of the trial
Time frame: 1 year after surgery
Number of Participants With Major Complications
Major complications include surgical site infection, ventral incisional hernia, and/or reoperation
Time frame: 3 years after surgery
Number of Participants With Surgical Site Infections
Time frame: 3 years after surgery
Number of Participants With Reoperations
any unplanned invasive procedure involving the fascia, mesh, or peritoneal cavity
Time frame: 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
Time frame: 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
Time frame: 3 years after surgery
Cost Analyses
calculated from the hospital's perspective by assessing charges for all patient visits, admissions, and procedures
Time frame: 3 years after surgery
Surgeon Perception
likert type and open ended questions assessing perception, barriers and likelihood of utilizing interventions outside of the trial
Time frame: 3 years after surgery
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