Effect of Materials for Subcuticular Suture (Quill vs. Monocryl) on Complications After Liver Resection

April 11, 2023 updated by: M.D. Anderson Cancer Center

Effect of Materials for Subcuticular Suture (Quill® vs. Monocryl®) on Complications After Liver Resection

This study investigates the effect of materials used in subcuticular suture on patients' outcomes after surgery. The prevention of surgical site wound infection is important to decrease the length of hospital stay and the post-operative risk of incisional hernia, especially in patients undergoing open hepatectomy (surgical removal of the liver). The purpose of this study is to compare the impact of the use of Quill versus Monocryl for subcuticular suture on patients' outcomes after surgery.

Study Overview

Status

Recruiting

Detailed Description

PRIMARY OBJECTIVE:

I. To investigate the impact of materials for subcuticular suture (Quill versus [vs.] Monocryl) on complications after liver resection.

OUTLINE:

Patients' medical records are reviewed retrospectively.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Jean-Nicolas Vauthey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing liver resection at MD Anderson Cancer Center from June 1, 2020 through January 31, 2021

Description

Inclusion Criteria:

  • Patients >= 18 years of age undergoing liver resection at MD Anderson Cancer Center from June 1, 2020 through January 31, 2021

Exclusion Criteria:

  • Patients who have a history of previous abdominal surgery will be excluded
  • Pregnant women will not be included in this chart review

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (medical record review)
Patients' medical records are reviewed retrospectively.
Medical records are reviewed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of complications after liver resection
Time Frame: 1 year
The impact of materials for subcuticular suture (Quill versus Monocryl) on complications after liver resection will be evaluated.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jean-Nicolas Vauthey, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

May 12, 2021

First Submitted That Met QC Criteria

May 27, 2021

First Posted (Actual)

May 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2021-0258 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2021-03485 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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