Tissue Reinforcement of Incisional Closure Among High Risk Patients

The University of Texas System (UT)

Status: Terminated

Conditions: Wound Complication

Treatments: Procedure: Small Bites; Procedure: Large Bites; Device: Biologic Mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT03148496

HSC-MS-17-0063

Details and patient eligibility

About

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.

Enrollment: 163 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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163 participants in 4 patient groups

Biologic Mesh and Small Bites

Experimental group

Description:

Biologic mesh placement and small bites used for suturing.

Treatment:

Procedure: Small Bites

Device: Biologic Mesh

Small Bites and No Biologic Mesh

Experimental group

Description:

Small bites used for suturing with no placement of biologic mesh

Treatment:

Procedure: Small Bites

Biologic mesh and Large Bites

Experimental group

Description:

Biologic mesh placement and large bites used for suturing

Treatment:

Procedure: Large Bites

Device: Biologic Mesh

Large Bites and no biologic mesh

Active Comparator group

Description:

Large bites used for suturing and no placement of biologic mesh.

Treatment:

Procedure: Large Bites