Oxidized Regenerated Cellulose to Decrease Vaginal Cuff Complications

Use of Structured Non-woven Absorbable Hemostat (or Oxidized Regenerated Cellulose) to Decrease Vaginal Cuff Dehiscence Rate in Laparoscopic Hysterectomy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01584128

Enrollment

101

Registered

2012-04-24

Start date

2012-04-30

Completion date

2013-03-01

Last updated

2017-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Cuff Complications

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* female, ages 20-80, undergoing laparoscopic hysterectomy

Exclusion criteria

* malignant indications for hysterectomy

Design outcomes

Primary

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

Countries

United States

Outcome results