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NCT03148496 · ClinicalTrials.gov registry record · NA
Tissue Reinforcement of Incisional Closure Among High Risk Patients
A NA study, sponsored by The University of Texas Health Science Center, Houston.
- Terminated
- Registry status
- NA
- Development phase
- 163
- Enrollment target
NCT03148496 is a NA study that was terminated before completion, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 163 participants.
The verdict
NCT03148496, a NA study, was terminated before completion, sponsored by The University of Texas Health Science Center, Houston.
- TERMINATED
- Registry status
- NA
- Development phase
- 163 participants
- Enrollment target
Study 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 u
Interventions
- DEVICE Biologic Mesh
- PROCEDURE Small Bites
- PROCEDURE Large Bites
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2017-09-13 |
| Est. Completion | 2021-06-19 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03148496
The ClinicalTrials.gov registry entry for NCT03148496 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 163 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Biologic Mesh is the first listed.
NCT03148496 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03148496 about?
NCT03148496 is a clinical study titled "Tissue Reinforcement of Incisional Closure Among High Risk Patients". 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, fa...
What is the current status of trial NCT03148496?
This trial is currently terminated. It is a NA study. The enrollment target is 163 participants. The study started on 2017-09-13. Estimated completion is 2021-06-19.
What interventions are being tested in trial NCT03148496?
The interventions under investigation include: Biologic Mesh (DEVICE), Small Bites (PROCEDURE), Large Bites (PROCEDURE).
Who is sponsoring clinical trial NCT03148496?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
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