Oxidized Regenerated Cellulose to Decrease Vaginal Cuff Complications

Completed

• Conditions: Vaginal Cuff Complications

• Registration Number: NCT01584128
• Lead Sponsor: Milton S. Hershey Medical Center

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).

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-21
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-24
• Primary Completion: 2013-03-01
• Study Completion: 2013-03-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 101

Inclusion Criteria

• female, ages 20-80, undergoing laparoscopic hysterectomy

Exclusion Criteria

• malignant indications for hysterectomy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of vaginal cuff complications	postoperative	Incidence of vaginal cuff complicationsincluding vaginal cuff dehiscence, vaginal cuff cellulitis, and vaginal cuff abscess

Trial Locations

Locations (1)

Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States