Tissue Reinforcement of Incisional Closure Among High Risk Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 163
- Locations
- 2
- Primary Endpoint
- Proportion of Participants Major Chronic Wound Infection
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Biologic Mesh and Small Bites
Biologic mesh placement and small bites used for suturing.
Intervention: Biologic Mesh (Device)
Biologic Mesh and Small Bites
Biologic mesh placement and small bites used for suturing.
Intervention: Small Bites (Procedure)
Small Bites and No Biologic Mesh
Small bites used for suturing with no placement of biologic mesh
Intervention: Small Bites (Procedure)
Biologic mesh and Large Bites
Biologic mesh placement and large bites used for suturing
Intervention: Biologic Mesh (Device)
Biologic mesh and Large Bites
Biologic mesh placement and large bites used for suturing
Intervention: Large Bites (Procedure)
Large Bites and no biologic mesh
Large bites used for suturing and no placement of biologic mesh.
Intervention: Large Bites (Procedure)
Outcomes
Primary Outcomes
Proportion of Participants Major Chronic Wound Infection
Time Frame: 1 year after surgery
Proportion of participants with major chronic wound infection
Secondary Outcomes
- Number of Participants With Surgical Site Infections(3 years after surgery)
- Surgeon Perception(3 years after surgery)
- Participants Health Status as Assessed by the Euroqol-5D Questionnaire(3 years after surgery)
- Cost Analyses(3 years after surgery)
- Number of Participants With Major Complications(3 years after surgery)
- Operative Duration(about 119 minutes to 337 minutes)
- Number of Participants With Reoperations(3 years after surgery)
- Participants Quality of Life as Assessed by Activities Assessment Scale(3 years after surgery)
- Number of Participants With Major Complications(1 year after surgery)
- Number of Participants With Surgical Site Infections(1 year after surgery)
- Number of Participants With Reoperations(1 year after surgery)
- Participants Quality of Life as Assessed by Activities Assessment Scale(1 year after surgery)
- Participants Health Status as Assessed by the Euroqol-5D Questionnaire(1 year after surgery)
- Cost Analyses(1 year after surgery)
- Surgeon Perception(1 year after surgery)
Investigators
Julie Holihan
Assistant Professor of Surgery-Clinical
The University of Texas Health Science Center, Houston