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Sponsored by: |
London School of Hygiene and Tropical Medicine |
Information provided by: | London School of Hygiene and Tropical Medicine |
ClinicalTrials.gov Identifier: | NCT00522860 |
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 |
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 |
Estimated Enrollment: | 1300 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | May 2010 |
Arms | Assigned Interventions |
A: Experimental
Vicryl sutures
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Procedure: Trichiasis surgery with absorbable sutures |
B: Active Comparator
Silk sutures
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Procedure: Trichiasis surgery with non-absorbable sutures |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Matthew J Burton, PhD MRCOphth | matthew.burton@lshtm.ac.uk | |
Contact: Saul N Rajak, MRCOphth | saul.rajak@lshtm.ac.uk |
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 |
London School of Hygiene and Tropical Medicine |
Principal Investigator: | Matthew J Burton, PhD MRCOphth | London School of Hygiene and Tropical Medicine |
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 |
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