Oxidized Regenerated Cellulose to Decrease Vaginal Cuff Complications

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Milton S. Hershey Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Carrie Hossler, MD, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01584128
First received: April 21, 2012
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

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.


Condition
Vaginal Cuff Complications

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Structured Non-woven Absorbable Hemostat (or Oxidized Regenerated Cellulose) to Decrease Vaginal Cuff Dehiscence Rate in Laparoscopic Hysterectomy

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Incidence of vaginal cuff complications [ Time Frame: postoperative ] [ Designated as safety issue: No ]
    Incidence of vaginal cuff complicationsincluding vaginal cuff dehiscence, vaginal cuff cellulitis, and vaginal cuff abscess


Estimated Enrollment: 250
Study Start Date: April 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Oxidized regenerated cellulose
Patients undergoing laparoscopic hysterectomy who have oxidized regenerated cellulose placed at the vaginal cuff at the time of their surgery.

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).

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

women, age 20-80, undergoing laparoscopic hysterectomy

Criteria

Inclusion Criteria:

  • female, ages 20-80, undergoing laparoscopic hysterectomy

Exclusion Criteria:

  • malignant indications for hysterectomy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01584128

Contacts
Contact: Carrie A Hossler, MD 717-968-6477 chossler@hmc.psu.edu

Locations
United States, Pennsylvania
Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Carrie A Hossler, MD    717-968-6477    chossler@hmc.psu.edu   
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Carrie A Hossler, MD Hershey Medical Center
  More Information

No publications provided

Responsible Party: Carrie Hossler, MD, Resident, PGY 2, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01584128     History of Changes
Other Study ID Numbers: 38775EP
Study First Received: April 21, 2012
Last Updated: April 23, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 23, 2014