A Trial of Non-absorbable Versus Absorbable Sutures for Trichiasis Surgery
A Randomised Controlled Trial of Non-absorbable (Silk) Sutures Verses Absorbable (Vicryl) Sutures During the Surgical Treatment of Trachomatous Trichiasis
Sponsor study identifier
interventional
1,300
1 country
1
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2010
Actual (reported)Study Completion
May 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2010
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 28, 2007
Actual (reported)August 30, 2007
Actual (reported)March 2008
Date type not reportedThis date has not been verified as actual or estimated.
May 2010
Actual (reported)May 2010
Actual (reported)Recurrent trichiasis
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.
One and two years
Entropion
One and two years
Corneal opacity
One and two years
Visual Acuity Change
One and Two years
Conjunctivilisation of the lid margin grade
One and two years
Repeat Trichiasis Surgery
At any time during two years followup.
Vicryl sutures, 5/0, 3/8 curved cutting needle
Silk suture, 4/0, 3/8 curved cutting needle
Posterior lamellar tarsal rotation. Vicryl sutures, 5/0, 3/8 curved needle, cutting. Three everting sutures.
Posterior lamellar tarsal rotation. Silk sutures. 4/0. 3/8 curved cutting needle. Three sets of everting sutures.
Bahir Dar Regional Health Bureau
Bahir Dar, Amhara, Ethiopia
Rajak SN, Habtamu E, Weiss HA, Kello AB, Gebre T, Genet A, Bailey RL, Mabey DC, Khaw PT, Gilbert CE, Emerson PM, Burton MJ. Absorbable versus silk sutures for surgical treatment of trachomatous trichiasis in Ethiopia: a randomised controlled trial. PLoS Med. 2011 Dec;8(12):e1001137. doi: 10.1371/journal.pmed.1001137. Epub 2011 Dec 13.
Gower EW, Munoz B, Rajak S, Habtamu E, West SK, Merbs SL, Harding JC, Alemayehu W, Callahan EK, Emerson PM, Gebre T, Burton MJ. Pre-operative trichiatic eyelash pattern predicts post-operative trachomatous trichiasis. PLoS Negl Trop Dis. 2019 Oct 7;13(10):e0007637. doi: 10.1371/journal.pntd.0007637. eCollection 2019 Oct.
Matthew J Burton, PhD FRCOphth
London School of Hygiene and Tropical Medicine
1,300 participants (actual enrollment reported by the registry).
First Submitted
August 28, 2007
First Posted
August 30, 2007
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Azithromycin in Control of Trachoma II
Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Rajak SN, Habtamu E, Weiss HA, Bedri A, Zerihun M, Gebre T, Gilbert CE, Emerson PM, Burton MJ. Why do people not attend for treatment for trachomatous trichiasis in Ethiopia? A study of barriers to surgery. PLoS Negl Trop Dis. 2012;6(8):e1766. doi: 10.1371/journal.pntd.0001766. Epub 2012 Aug 28.
Primary Completion
May 2010
Actual (reported)Study Completion
May 2010
Actual (reported)Last Updated
January 12, 2012
Record last verified: 2012-01
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Source: ClinicalTrials.gov.
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