The Treatment of Bartholin´s Cyst or Abscess With Silver Nitrate

Bartholin´s Cyst Clinical Trial

Official title:

The Treatment of Bartholin´s Cyst or Abscess With Silver Nitrate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00786461
• Other study ID #: 2005-000494-22
• Status: Recruiting
• Phase: Phase 4
• First received: November 5, 2008
• Last updated: November 5, 2008
• Start date: March 2007
• Est. completion date: December 2009

Study information

• Verified date: November 2008
• Source: University of Aarhus
• Contact: Pinar Bor, MD, Ph.d
• Phone: +45 89102503
• Email: pinarbor[@]yahoo.com
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Silver nitrate treatment of Bartholin's cyst or abscess will be compared to marsupialization treatment.

It is expected that silver nitrate treatment is effective, simple, inexpensive and the least anaesthetic requiring procedure, which can easily be carried out in the outpatient setting.

Description:

Background and objective:

Bartholin gland cysts and abscesses are common problems in women of reproductive age. The traditional treatment of Bartholin´s cyst or abscess is marsupialization, which has disadvantages, such as pain of long duration, scarring, risk of general anaesthesia and risk of recurrence. In the present study we use silver nitrate in the treatment of Bartholin's cyst or abscess and compare to marsupialization. We expect lower healing time, lower recurrence rate and less pain with the silver nitrate treatment.

Methods and materials:

30 patients with Bartholin´s cyst or abscess will be investigated. It is prospective randomized study. The silver nitrate treatment is performed under local anaesthesia on an outpatient basis. A simple vertical incision 1 cm in length is made in the vaginal mucosa and the underlying cyst or abscess wall. A crystalloid silver nitrate stick of 5 mm in diameter and 5 mm in length is inserted into the cyst or abscess cavity.

The standard marsupialization treatment is performed under general anaesthesia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Women with a age of 18-60 years

• Should read and understand Danish

• All women inclusive pregnant should have a Bartholins cyst or abscess

Exclusion Criteria:

• Subject who cannot give written informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bartholin´s Cyst
• Cysts

Intervention

Procedure:
• silver nitrate application to the Bartholin´s cyst
5 mm in diameter and 5 mm in length crystalloid silver nitrate stick is inserted into the cyst or abscess cavity.
• silver nitrat stick
The silver nitrate treatment is performed under local anaesthesia on an outpatient basis. A simple vertical incision 1 cm in length is made in the vaginal mucosa and the underlying cyst or abscess wall. A crystalloid silver nitrate stick of 5 mm in diameter and 5 mm in length is inserted into the cyst or abscess cavity.

Locations

Country	Name	City	State
Denmark	Randers Central Hospital	Randers

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Randers Regional Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recidive of bartholin´s cyst or abscess and Dyspareunia after treatment		up to one year after treatment	No
Secondary	Wound healing, local burning, sequelae, hospitalisation time		3-4 weeks after treatment	No