Oxidized Regenerated Cellulose to Decrease Vaginal Cuff Complications

NCT ID: NCT01584128

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 101 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-03-01

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).

Conditions

Vaginal Cuff Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Oxidized regenerated cellulose

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• female, ages 20-80, undergoing laparoscopic hysterectomy

Exclusion Criteria

• malignant indications for hysterectomy

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carrie A Hossler, MD

Role: PRINCIPAL_INVESTIGATOR

Hershey Medical Center

Locations

Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

38775EP

Identifier Type: -

Identifier Source: org_study_id