Clinical trial NCT02424357: Suture Contamination Rate in Adjustable Suture Strabismus Surgery
Official title: Suture Contamination Rate in Adjustable Suture Strabismus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suture Strabismus Surgery
Keywords: Adjustable strabismus surgery
suture contamination
5%povidone iodine
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2015-04-23
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 1. To establish the culture positivity rate in adjustable suture strabismus surgery
2. To identify bacterial species and antibiotic susceptibility patterns of microorganisms cultured from suture material
3. To compare suture contamination rates with techniques to reduce the suture contamination rate

Detailed description: Patients will be randomized into 1 of 2 groups: those who received 1 drop of 5% povidone-iodine instilled directly over the sliding noose at surgery completion (group 1) and those who did not receive povidone-iodine at the end of the surgery (group 2).

Institutional standard surgical preparation will be performed in all patients with 5% povidone-iodine solution on the periocular skin and eyelid margins, followed by instillation of 1 drop of 5% povidone-iodine into the conjunctival cul-de-sac.

All operations will be performed using a sliding noose technique with a polyglactin 6-0 suture (Vicryl, Ethicon Inc). If a patient undergoes surgery on more than 1 muscle in the same eye, a 1-cm section of suture proximal to the knot will be collected from the nonadjustable suture as a control. The control suture will be placed in a tube with 2 mL of trypticase soy broth and agitated for 1 minute. At the end of surgery, patients in group 1 will receive a drop of povidone-iodine. A strip of neomycin sulfate, polymyxin B sulfate, and dexamethasone ophthalmic ointment will be then applied into the lower conjunctival fornix to patients in both groups.

Eligibility criteria: Inclusion Criteria:

* All strabismus patients age ≥ 18 years scheduled for strabismus surgery with adjustable sutures at the Bascom Palmer Eye Institute will be invited to participate.

Exclusion Criteria:

* Patient who has a history of allergy to povidone-iodine.
* Disorders affecting immune function.
* Patient who is unwilling to participate in the study

Primary outcomes:
measure: Suture Colonization Rate in Adjustable Suture Strabismus Surgery
timeFrame: 48 hours
Secondary outcomes:
measure: Reduction of Contamination Rate Using Post-operative 5% Povidone Iodine
timeFrame: 48 hours
measure: Identification of Bacterial Species Cultured From Suture Material
timeFrame: 7 days plus 24 to 48 hours
Other outcomes:
Locations:
city: Miami
country: United States
facility: Bascom Palmer Eye Institute, University of Miami
state: Florida
Study officials:
affiliation: Bascom Palmer Eye Institute
name: Hilda Capo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eustis HS, Rhodes A. Suture contamination in strabismus surgery. J Pediatr Ophthalmol Strabismus. 2012 Jul-Aug;49(4):206-9. doi: 10.3928/01913913-20110920-01.
citation: Olitsky SE, Vilardo M, Awner S, Reynolds JD. Needle sterility during strabismus surgery. J AAPOS. 1998 Jun;2(3):151-2. doi: 10.1016/s1091-8531(98)90006-4.
citation: Carothers TS, Coats DK, McCreery KM, Rossman SN, Wilson P, Wu TG, Paysse EA. Quantification of incidental needle and suture contamination during strabismus surgery. Binocul Vis Strabismus Q. 2003;18(2):75-9.
citation: Apt L, Isenberg SJ, Yoshimori R, Chang A, Lam GC, Wachler B, Neumann D. The effect of povidone-iodine solution applied at the conclusion of ophthalmic surgery. Am J Ophthalmol. 1995 Jun;119(6):701-5. doi: 10.1016/s0002-9394(14)72773-4.
citation: Rossetto JD, Suwannaraj S, Cavuoto KM, Spierer O, Miller D, McKeown CA, Capo H. Evaluation of Postoperative Povidone-Iodine in Adjustable Suture Strabismus Surgery to Reduce Suture Colonization: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Oct 1;134(10):1151-1155. doi: 10.1001/jamaophthalmol.2016.2926.