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Trial record 1 of 1 for:    NCT00522860
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A Trial of Non-absorbable Versus Absorbable Sutures for Trichiasis Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00522860
First Posted: August 30, 2007
Last Update Posted: January 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Non-absorbable (Silk) Sutures Verses Absorbable (Vicryl) Sutures During the Surgical Treatment of Trachomatous Trichiasis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Recurrent trichiasis [ Time Frame: One and two years ]
    Recurrent trichiasis, defined as one or more eyelashes touching the globe or evidence of epilation (lash stubs) on examination, or a history of repeat trichiasis surgery since the baseline surgery, at one year.


Secondary Outcome Measures:
  • Entropion [ Time Frame: One and two years ]
  • Corneal opacity [ Time Frame: One and two years ]
  • Visual Acuity Change [ Time Frame: One and Two years ]
  • Conjunctivilisation of the lid margin grade [ Time Frame: One and two years ]
  • Repeat Trichiasis Surgery [ Time Frame: At any time during two years followup. ]

Enrollment: 1300
Study Start Date: March 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vicryl Suture
Vicryl sutures, 5/0, 3/8 curved cutting needle
Procedure: Trichiasis surgery with absorbable sutures
Posterior lamellar tarsal rotation. Vicryl sutures, 5/0, 3/8 curved needle, cutting. Three everting sutures.
Active Comparator: Silk Suture
Silk suture, 4/0, 3/8 curved cutting needle
Procedure: Trichiasis surgery with non-absorbable sutures
Posterior lamellar tarsal rotation. Silk sutures. 4/0. 3/8 curved cutting needle. Three sets of everting sutures.

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  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major trichiasis: more than 5 lashes touching the eye

Exclusion Criteria:

  • Previous eyelid surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00522860


Locations
Ethiopia
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 FRCOphth London School of Hygiene and Tropical Medicine
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00522860     History of Changes
Other Study ID Numbers: 5025
First Submitted: August 28, 2007
First Posted: August 30, 2007
Last Update Posted: January 12, 2012
Last Verified: January 2012

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

Additional relevant MeSH terms:
Trachoma
Trichiasis
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections
Infection
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Eyelid Diseases