NCT01584128

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

11 months

First QC Date

April 21, 2012

Last Update Submit

May 2, 2017

Conditions

Vaginal Cuff Complications

Outcome Measures

Primary Outcomes (1)

  • Incidence of vaginal cuff complications

    Incidence of vaginal cuff complicationsincluding vaginal cuff dehiscence, vaginal cuff cellulitis, and vaginal cuff abscess

    postoperative

Study Arms (1)

Oxidized regenerated cellulose

Patients undergoing laparoscopic hysterectomy who have oxidized regenerated cellulose placed at the vaginal cuff at the time of their surgery.

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women, age 20-80, undergoing laparoscopic hysterectomy

You may qualify if:

  • female, ages 20-80, undergoing laparoscopic hysterectomy

You may not qualify if:

  • malignant indications for hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Study Officials

  • Carrie A Hossler, MD

    Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 21, 2012

First Posted

April 24, 2012

Study Start

April 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

May 5, 2017

Record last verified: 2017-05

Locations

US(1)