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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5% povidone iodine ophthalmic solution | Experimental | patient received 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion |
|
| no povidone-iodine ophthalmic solution | Active Comparator | patient received a routine antibiotic/steroid ointment to operated eye at surgery completion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5%povidone iodine ophthalmic solution | Drug | one drop of 5% povidone iodine instilled into the conjunctival fornix. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Suture Colonization Rate in Adjustable Suture Strabismus Surgery | 1 cm section of the suture proximal to the knot will be harvested and placed in a tube with 2 ml of trypticase soy broth (TSB).The TSB tubes will be monitored for growth of bacteria at 48 hours | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Contamination Rate Using Post-operative 5% Povidone Iodine | Comparison of suture colonization rates with and without instillation of a drop of povidone-iodine at surgery completion | 48 hours |
| Identification of Bacterial Species Cultured From Suture Material |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hilda Capo, MD | Bascom Palmer Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bascom Palmer Eye Institute, University of Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22909077 | Background | 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. | |
| 10532751 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 5% Povidone Iodine Ophthalmic Solution | patient received 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion |
| FG001 | no Povidone-iodine Ophthalmic Solution | patient received a routine antibiotic/steroid ointment to operated eye at surgery completion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 5% Povidone Iodine Ophthalmic Solution | patient received 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion |
| BG001 | no Povidone-iodine Ophthalmic Solution |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Suture Colonization Rate in Adjustable Suture Strabismus Surgery | 1 cm section of the suture proximal to the knot will be harvested and placed in a tube with 2 ml of trypticase soy broth (TSB).The TSB tubes will be monitored for growth of bacteria at 48 hours | Posted | Number | percentage sutures positive for bacteria | 48 hours | sutures | sutures |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 5% Povidone Iodine Ophthalmic Solution | patient received 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hilda Capo | University of Miami | 305-326-6555 | hcapo@med.miami.edu |
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The surgeon will be unaware of the randomization until the end of the surgery. All microbiology personnel and patients will be unaware of the interventional group
| routine post-operative ophthalmic ointment | Drug | patient received a routine antibiotic/steroid ointment to operated eye at surgery completion |
|
The collected sutures will be monitored for bacterial growth for up to 7 days. When bacterial growth is observed, 1 mL of the solution will be inoculated on chocolate, MacConkey, and anaerobic blood agars and incubated for an additional 24 to 48 hours to identify organisms and quantify growth. In vitro susceptibility patterns will be determined. |
| 7 days plus 24 to 48 hours |
| 12765540 | Background | 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. |
| 7540363 | Background | 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. |
| 27561000 | Derived | 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. |
patient received a routine antibiotic/steroid ointment to operated eye at surgery completion |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
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| Secondary | Reduction of Contamination Rate Using Post-operative 5% Povidone Iodine | Comparison of suture colonization rates with and without instillation of a drop of povidone-iodine at surgery completion | Posted | Number | 95% Confidence Interval | relative risk | 48 hours | sutures | sutures |
|
|
|
| Secondary | Identification of Bacterial Species Cultured From Suture Material | The collected sutures will be monitored for bacterial growth for up to 7 days. When bacterial growth is observed, 1 mL of the solution will be inoculated on chocolate, MacConkey, and anaerobic blood agars and incubated for an additional 24 to 48 hours to identify organisms and quantify growth. In vitro susceptibility patterns will be determined. | All 65 participants were analyzed: 53 sutures had positive cultures (34 of the adjustable sutures and 19 of the control sutures). The relative risk between the two treatment arms indicated no difference in colonization rate, the bacterial species were not analyzed separately. Three of the sutures yielded 2 bacterial species. | Posted | Number | number of positive bacterial isolates | 7 days plus 24 to 48 hours | sutures | sutures |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | no Povidone-iodine Ophthalmic Solution | patient received a routine antibiotic/steroid ointment to operated eye at surgery completion | 0 | 30 | 0 | 30 |
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| Title | Measurements |
|---|---|
|
| Staphylococcus capitis |
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| Staphylococcus hominis |
|
| Propionibacterium acnes |
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| Staphylococcus cohnii |
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| Staphylococcus warneri |
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| Staphylococcus xylosus |
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| Citrobacter koseri |
|
| Lactococcus lactis |
|