NCT03917134

Prevention of Vaginal Cellulitis or Vaginal Cuff Abscess After Laparoscopic Hysterectomy

Status unknown NA Last updated 16 April 2019

What this trial tests

NA trial testing cephalosporin + Metronidazole Vaginal in Hysterectomy in 600 participants. Status unknown.

Timeline

1 May 2019

Primary endpoint
30 January 2020

30 January 2020

Quick facts

Lead sponsor	CES University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	600
Start date	1 May 2019
Primary completion	30 January 2020
Estimated completion	30 January 2020
Sites	2 locations across Colombia

Drugs / interventions tested

• cephalosporin + Metronidazole Vaginal — full drug profile →
• cephalosporin + Placebos — full drug profile →

Conditions studied

• Hysterectomy — all drugs for Hysterectomy →
• Cellulitis — all drugs for Cellulitis →
• Vaginosis — all drugs for Vaginosis →
• Abscess — all drugs for Abscess →

Sponsor

CES University

Who can join

Adults 18 to 55, female only, with Hysterectomy or Cellulitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Operative site infection remains the most common complication after performing a gynecological procedure, and has a great implication in the morbidity and mortality of patients. Gynecological procedures, including laparoscopic hysterectomy, represent a unique challenge due to the amount of microorganisms found at the skin level of the vagina or the endocervix.

However, there is no clear evidence that the complication decreases with the use of postoperative antibiotics.

With the completion of this study, a multicentre triple-blind controlled randomized controlled trial is intended to determine the behavior of the application of this intervention.

Patients who attend an outpatient clinic with benign pathology will be selected, in which indication of laparoscopic hysterectomy, consents are completed and research content is widely explained. Prior to surgery, the sample is taken for a gram of vaginal discharge and in the post-surgical phase delivery of the medication will be performed. Follow-up will be carried out by surgical control and by telephone.

The investigator intend to find that with the prophylaxis not only of presurgical cephalosporin, but with the formulation of metronidazole ovules in the postoperative, the incidence of laparoscopic post-hysterectomy vaginal abscess and cellulitis of cuff is reduced.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.