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A Trial of Non-Absorbable Versus Absorbable Sutures for Trichiasis Surgery

This study is not yet open for participant recruitment.
Verified by London School of Hygiene and Tropical Medicine, August 2007

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:   October 2007
Estimated Study Completion Date:   May 2010

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

Contacts
Contact: Matthew J Burton, PhD MRCOphth     matthew.burton@lshtm.ac.uk    
Contact: Saul N Rajak, MRCOphth     saul.rajak@lshtm.ac.uk    

Locations
Ethiopia, Amhara
Bahir Dar Regional Health Bureau     Not yet recruiting
      Bahir Dar, Amhara, Ethiopia
      Contact: Saul N Rajak, MRCOphth         saul.rajak@lshtm.ac.uk    
      Principal Investigator: Saul N Rajak, MRCOphth            

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
First Received:   August 28, 2007
Last Updated:   January 30, 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 October 10, 2008




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