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A Trial of Non-Absorbable Versus Absorbable Sutures for Trichiasis Surgery
This study is ongoing, but not recruiting participants.
Sponsored by: London School of Hygiene and Tropical Medicine
Information provided by: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00522860
  Purpose

Trachoma is the leading infectious cause of blindness worldwide. Recurrent infection by Chlamydia trachomatis causes in-turning of the eyelids / lashes (trichiasis), leading to corneal damage and blindness. The WHO recommends corrective eyelid surgery for trichiasis. Unfortunately, trichiasis frequently returns following surgery. The purpose of this study is to compare the outcome of surgery (at one and two years) for trichiasis using two currently used alternative suture types: non-absorbable (silk) and absorbable (vicryl). We, the researchers, hypothesise that the supportive presence of the absorbable suture for a longer period produces more stable wound healing, leading to a better outcome.


Condition Intervention Phase
Trachomatous Trichiasis
Trachoma
Procedure: Trichiasis surgery with absorbable sutures
Procedure: Trichiasis surgery with non-absorbable sutures
Phase IV

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: A Randomised Controlled Trial of Non-Absorbable (Silk) Sutures Verses Absorbable (Vicryl) Sutures During the Surgical Treatment of Trachomatous Trichiasis

Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Recurrent trichiasis [ Time Frame: One and two years ]

Secondary Outcome Measures:
  • Visual acuity [ Time Frame: One and two years ]
  • Corneal opacity [ Time Frame: One and two years ]

Estimated Enrollment: 1300
Study Start Date: March 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Vicryl sutures
Procedure: Trichiasis surgery with absorbable sutures
B: Active Comparator
Silk sutures
Procedure: Trichiasis surgery with non-absorbable sutures

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major trichiasis: more than 5 lashes touching the eye

Exclusion Criteria:

  • Previous eyelid surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00522860

Locations
Ethiopia, Amhara
Bahir Dar Regional Health Bureau
Bahir Dar, Amhara, Ethiopia
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Investigators
Principal Investigator: Matthew J Burton, PhD MRCOphth London School of Hygiene and Tropical Medicine
  More Information

Study ID Numbers: 5025
Study First Received: August 28, 2007
Last Updated: December 18, 2008
ClinicalTrials.gov Identifier: NCT00522860  
Health Authority: United Kingdom: Research Ethics Committee;   Ethiopia: Ethiopia Science and Technology Commission;   United States: Institutional Review Board

Keywords provided by London School of Hygiene and Tropical Medicine:
Trichiasis
Trachoma
Surgery
Suture
Ethiopia

Study placed in the following topic categories:
Bacterial Infections
Corneal Diseases
Eye Infections, Bacterial
Conjunctivitis, Bacterial
Eye Diseases
Chlamydia Infections
Eye Infections
Conjunctivitis
Conjunctival Diseases
Gram-Negative Bacterial Infections
Trachoma

Additional relevant MeSH terms:
Chlamydiaceae Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009