NCT04906174

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 12, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

2.7 years

First QC Date

May 12, 2021

Last Update Submit

April 11, 2023

Conditions

Liver and Intrahepatic Bile Duct Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Incidence of complications after liver resection

    The impact of materials for subcuticular suture (Quill versus Monocryl) on complications after liver resection will be evaluated.

    1 year

Study Arms (1)

Observational (medical record review)

Patients' medical records are reviewed retrospectively.

Other: Electronic Health Record Review

Interventions

Electronic Health Record ReviewOTHER

Medical records are reviewed

Observational (medical record review)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

Study Officials

  • Jean-Nicolas Vauthey

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2021

First Posted

May 28, 2021

Study Start

April 10, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

April 12, 2023

Record last verified: 2023-04

Locations

US(1)