Oxidized Regenerated Cellulose to Decrease Vaginal Cuff C... | NCT01584128

Studies
Oxidized Regenerated Cellulose to Decrease Vaginal Cuff Complications

NCT01584128

Sponsor

Milton S. Hershey Medical Center

Status

Completed

Last Update Posted

May 5, 2017Actual

Enrollment

101Actual

Phase

Not provided

Conditions

Vaginal Cuff Complications

Interventions

Not provided

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

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Mar 1, 2013Actual

Completion Date

Mar 1, 2013Actual

First Submitted Date

Apr 21, 2012

First Submission Date that Met QC Criteria

Apr 23, 2012

First Posted Date

Apr 24, 2012Estimated

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

May 2, 2017

Last Update Posted Date

May 5, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The goal of the investigators study is to determine whether the use of oxidized regenerated cellulose reduces the risk of vaginal cuff cellulitis, pelvic abscess, or vaginal cuff dehiscence in patients undergoing laparoscopic hysterectomy. The investigators hypothesize that the use of oxidized regenerated cellulose will reduce the risk of vaginal cuff cellulitis, pelvic abscess, and vaginal cuff dehiscence in patients undergoing laparoscopic hysterectomy.

Detailed Description

Structured non-woven absorbable hemostat (or oxidized regenerated cellulose) was designed and marketed for its hemostatic properties. It is used in our practice to achieve hemostasis at the site of the vaginal cuff closure during laparoscopic hysterectomy. While the hemostatic properties of oxidized regenerated cellulose are well known and documented, there is newer research to suggest that oxidized regenerated cellulose may have antimicrobial activity. One In vitro study investigated the antimicrobial activity of oxidized regenerated cellulose products against multiple antibiotic resistant microorganisms and found that the antimicrobial affect of the oxidized regenerated cellulose products was significantly greater than that of the controls. There are a limited number of studies investigating the antimicrobial activity of oxidized regenerated cellulose products in vivo (and none in gynecologic surgery).

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

101Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oxidized regenerated cellulose		Patients undergoing laparoscopic hysterectomy who have oxidized regenerated cellulose placed at the vaginal cuff at the time of their surgery.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of vaginal cuff complications	Incidence of vaginal cuff complicationsincluding vaginal cuff dehiscence, vaginal cuff cellulitis, and vaginal cuff abscess	postoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

female, ages 20-80, undergoing laparoscopic hysterectomy

Exclusion Criteria:

malignant indications for hysterectomy

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

women, age 20-80, undergoing laparoscopic hysterectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carrie A Hossler, MD	Hershey Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hershey Medical Center		Hershey	Pennsylvania	17033	United States