Tissue Reinforcement of Incisional Closure Among High Risk Patients

Not Applicable

Terminated

Conditions: Wound Complication

Interventions: Procedure: Large Bites
Device: Biologic Mesh
Procedure: Small Bites

Registration Number: NCT03148496

Lead Sponsor: The University of Texas Health Science Center, Houston

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:

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 163

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Large Bites and no biologic mesh	Large Bites	Large bites used for suturing and no placement of biologic mesh.
Biologic Mesh and Small Bites	Biologic Mesh	Biologic mesh placement and small bites used for suturing.
Biologic Mesh and Small Bites	Small Bites	Biologic mesh placement and small bites used for suturing.
Biologic mesh and Large Bites	Biologic Mesh	Biologic mesh placement and large bites used for suturing
Biologic mesh and Large Bites	Large Bites	Biologic mesh placement and large bites used for suturing
Small Bites and No Biologic Mesh	Small Bites	Small bites used for suturing with no placement of biologic mesh

Primary Outcome Measures

Name	Time	Method
Proportion of Participants Major Chronic Wound Infection	1 year after surgery	Proportion of participants with major chronic wound infection

Secondary Outcome Measures

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

Trial Locations

Locations (2): Lyndon B. Johnson (LBJ) Hospital
🇺🇸
Houston, Texas, United States
The University of Texas Health Science Center at Houston
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Houston, Texas, United States