- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04906174
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
Conditions
Intervention / Treatment
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:
- Jean-Nicolas Vauthey
- Phone Number: 713-792-6940
- Email: jvauthey@mdanderson.org
-
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.
Sponsor
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.
Helpful Links
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
Additional Relevant MeSH Terms
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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