Effect of Materials for Subcuticular Suture (Quill vs. Mo... | NCT04906174

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

NCT04906174

Sponsor

M.D. Anderson Cancer Center

Status

Unknown status

Last Update Posted

Apr 12, 2023Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Liver and Intrahepatic Bile Duct Neoplasm

Interventions

Electronic Health Record Review

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2021-03485	Registry Identifier	CTRP (Clinical Trial Reporting Program)
2021-0258	Other Identifier	M D Anderson Cancer Center

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 10, 2021Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

May 12, 2021

First Submission Date that Met QC Criteria

May 27, 2021

First Posted Date

May 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2023

Last Update Posted Date

Apr 12, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational (medical record review)		Patients' medical records are reviewed retrospectively.	Other: Electronic Health Record Review

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Electronic Health Record Review	Other	Medical records are reviewed	Observational (medical record review)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Nicolas Vauthey	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
M D Anderson Cancer Center	Recruiting	Houston	Texas	77030	United States