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Oxidized Regenerated Cellulose to Decrease Vaginal Cuff Complications

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Penn State Health

Status

Completed

Conditions

Vaginal Cuff Complications

Study type

Observational

Funder types

Other

Identifiers

NCT01584128
38775EP

Details and patient eligibility

About

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.

Full 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).

Enrollment

101 patients

Sex

Female

Ages

20 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • female, ages 20-80, undergoing laparoscopic hysterectomy

Exclusion criteria

  • malignant indications for hysterectomy

Trial design

101 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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