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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by University of Aarhus.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Department of Gynaecology and Obstetrics, Randers Hospital
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00786461
First received: November 5, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Bartholin´s Cyst
 Procedure: silver nitrate application to the Bartholin´s cyst
Procedure: silver nitrat stick
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Treatment of Bartholin´s Cyst or Abscess With Silver Nitrate

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Recidive of bartholin´s cyst or abscess and Dyspareunia after treatment [ Time Frame: up to one year after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Wound healing, local burning, sequelae, hospitalisation time [ Time Frame: 3-4 weeks after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Procedure: 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.
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786461

Contacts
Contact: Pinar Bor, MD, Ph.d +45 89102503 pinarbor@yahoo.com

Locations
Denmark
Randers Central Hospital Recruiting
Randers, Denmark, 8900
Contact: Pinar Bor, MD, PhD     004589102503     pinarbor@yahoo.com    
Sponsors and Collaborators
University of Aarhus
Department of Gynaecology and Obstetrics, Randers Hospital
  More Information

No publications provided

Responsible Party: Pinar Bor, M.D, Randers Hospital
ClinicalTrials.gov Identifier: NCT00786461     History of Changes
Other Study ID Numbers: 2005-000494-22
Study First Received: November 5, 2008
Last Updated: November 5, 2008
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Aarhus:
silver nitrate
marsupialisation

Additional relevant MeSH terms:
Cysts
Neoplasms
Pathological Conditions, Anatomical
Silver Nitrate
 Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013