Suture Strabismus Surgery
Conditions
Keywords
Adjustable strabismus surgery, suture contamination, 5%povidone iodine
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.
Interventions
DRUG5%povidone iodine ophthalmic solution
one drop of 5% povidone iodine instilled into the conjunctival fornix.
DRUGroutine post-operative ophthalmic ointment
patient received a routine antibiotic/steroid ointment to operated eye at surgery completion
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Suture Colonization Rate in Adjustable Suture Strabismus Surgery | 48 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Contamination Rate Using Post-operative 5% Povidone Iodine | 48 hours | Comparison of suture colonization rates with and without instillation of a drop of povidone-iodine at surgery completion |
| Identification of Bacterial Species Cultured From Suture Material | 7 days plus 24 to 48 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 35 |
| no Povidone-iodine Ophthalmic Solution patient received a routine antibiotic/steroid ointment to operated eye at surgery completion | 30 |
| Total | 65 |
Baseline characteristics
| Characteristic | 5% Povidone Iodine Ophthalmic Solution | no Povidone-iodine Ophthalmic Solution | Total |
|---|---|---|---|
| Age, Continuous | 48.5 years STANDARD_DEVIATION 16.8 | 46.6 years STANDARD_DEVIATION 18.1 | 47.6 years STANDARD_DEVIATION 17.3 |
| Sex: Female, Male Female | 18 Participants | 20 Participants | 38 Participants |
| Sex: Female, Male Male | 17 Participants | 10 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 30 |
| serious Total, serious adverse events | 0 / 35 | 0 / 30 |
Outcome results
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
Time frame: 48 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5% Povidone Iodine Ophthalmic Solution | Suture Colonization Rate in Adjustable Suture Strabismus Surgery | 57 percentage sutures positive for bacteria |
| no Povidone-iodine Ophthalmic Solution | Suture Colonization Rate in Adjustable Suture Strabismus Surgery | 47 percentage sutures positive for bacteria |
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.
Time frame: 7 days plus 24 to 48 hours
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 5% Povidone Iodine Ophthalmic Solution | Identification of Bacterial Species Cultured From Suture Material | Staphylococcus epidermidis | 40 number of positive bacterial isolates |
| 5% Povidone Iodine Ophthalmic Solution | Identification of Bacterial Species Cultured From Suture Material | Staphylococcus lugdunensis | 3 number of positive bacterial isolates |
| 5% Povidone Iodine Ophthalmic Solution | Identification of Bacterial Species Cultured From Suture Material | Staphylococcus aureus | 2 number of positive bacterial isolates |
| 5% Povidone Iodine Ophthalmic Solution | Identification of Bacterial Species Cultured From Suture Material | Staphylococcus capitis | 2 number of positive bacterial isolates |
| 5% Povidone Iodine Ophthalmic Solution | Identification of Bacterial Species Cultured From Suture Material | Staphylococcus hominis | 2 number of positive bacterial isolates |
| 5% Povidone Iodine Ophthalmic Solution | Identification of Bacterial Species Cultured From Suture Material | Propionibacterium acnes | 2 number of positive bacterial isolates |
| 5% Povidone Iodine Ophthalmic Solution | Identification of Bacterial Species Cultured From Suture Material | Staphylococcus cohnii | 1 number of positive bacterial isolates |
| 5% Povidone Iodine Ophthalmic Solution | Identification of Bacterial Species Cultured From Suture Material | Staphylococcus warneri | 1 number of positive bacterial isolates |
| 5% Povidone Iodine Ophthalmic Solution | Identification of Bacterial Species Cultured From Suture Material | Staphylococcus xylosus | 1 number of positive bacterial isolates |
| 5% Povidone Iodine Ophthalmic Solution | Identification of Bacterial Species Cultured From Suture Material | Citrobacter koseri | 1 number of positive bacterial isolates |
| 5% Povidone Iodine Ophthalmic Solution | Identification of Bacterial Species Cultured From Suture Material | Lactococcus lactis | 1 number of positive bacterial isolates |
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
Time frame: 48 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5% Povidone Iodine Ophthalmic Solution | Reduction of Contamination Rate Using Post-operative 5% Povidone Iodine | 1.1 relative risk |