Tissue Reinforcement of Incisional Closure Among High Risk Patients

NCT03148496 | Terminated Results DMC FDA Device

• 1 other identifier: HSC-MS-17-0063
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 2

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. 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. 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.

Conditions

Wound Complication

Keywords

abdominal surgery; wound complication

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Major Chronic Wound Infection

  Proportion of participants with major chronic wound infection

  1 year after surgery

Secondary Outcomes (15)

• 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

• Operative Duration

  about 119 minutes to 337 minutes

• Participants Quality of Life as Assessed by Activities Assessment Scale

  1 year after surgery

Study Arms (4)

Biologic Mesh and Small Bites

EXPERIMENTAL

Biologic mesh placement and small bites used for suturing.

Device: Biologic Mesh; Procedure: Small Bites

Small Bites and No Biologic Mesh

EXPERIMENTAL

Small bites used for suturing with no placement of biologic mesh

Procedure: Small Bites

Biologic mesh and Large Bites

EXPERIMENTAL

Biologic mesh placement and large bites used for suturing

Device: Biologic Mesh; Procedure: Large Bites

Large Bites and no biologic mesh

ACTIVE COMPARATOR

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

Procedure: Large Bites

Interventions

Biologic Mesh DEVICE

Biologic mesh placed during surgery

Biologic Mesh and Small Bites; Biologic mesh and Large Bites

Small Bites PROCEDURE

0.5 cm x 0.5 cm sutures used

Biologic Mesh and Small Bites; Small Bites and No Biologic Mesh

Large Bites PROCEDURE

1.0 x 1.0 sutures used

Biologic mesh and Large Bites; Large Bites and no biologic mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (2)

Lyndon B. Johnson (LBJ) Hospital

Houston, Texas, 77026, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (17)

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• Coelho R, Dhanani NH, Lyons NB, Bernardi K, Askenasy EP, Millas S, Holihan JL, Ali Z, Liang MK. Hernia Prevention Using Biologic Mesh and/or Small Bites: A Multispecialty 2 x 2 Factorial Randomized Controlled Trial. J Am Coll Surg. 2023 Aug 1;237(2):309-317. doi: 10.1097/XCS.0000000000000705. Epub 2023 Apr 11.

  PMID: 37458369 DERIVED

Results Point of Contact

• Title: Julie Holihan, MD
• Organization: The University of Texas Health Science Center at Houston

Julie.L.Holihan@uth.tmc.edu

713-500-7188

Study Officials

• Julie Holihan, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery-Clinical

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 11, 2017
• Study Start: September 13, 2017
• Primary Completion: June 19, 2021
• Study Completion: June 19, 2021
• Last Updated: July 22, 2022
• Results First Posted: July 22, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)