Trial Outcomes & Findings for Suture Contamination Rate in Adjustable Suture Strabismus Surgery (NCT NCT02424357)

Last Updated: 2017-11-30

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

65 participants

Primary outcome timeframe

48 hours

Results posted on

2017-11-30

Participant Flow

Participant milestones

Participant milestones
Measure	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	no Povidone-iodine Ophthalmic Solution patient received a routine antibiotic/steroid ointment to operated eye at surgery completion
Overall Study STARTED	35	30
Overall Study COMPLETED	35	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Suture Contamination Rate in Adjustable Suture Strabismus Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	5% Povidone Iodine Ophthalmic Solution n=35 Participants 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 n=30 Participants patient received a routine antibiotic/steroid ointment to operated eye at surgery completion	Total n=65 Participants Total of all reporting groups
Age, Continuous	48.5 years STANDARD_DEVIATION 16.8 • n=5 Participants	46.6 years STANDARD_DEVIATION 18.1 • n=7 Participants	47.6 years STANDARD_DEVIATION 17.3 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	10 Participants n=7 Participants	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	5% Povidone Iodine Ophthalmic Solution n=35 sutures 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 n=30 sutures patient received a routine antibiotic/steroid ointment to operated eye at surgery completion
Suture Colonization Rate in Adjustable Suture Strabismus Surgery	57 percentage sutures positive for bacteria	47 percentage sutures positive for bacteria

SECONDARY outcome

Timeframe: 48 hours

Comparison of suture colonization rates with and without instillation of a drop of povidone-iodine at surgery completion

Outcome measures

Outcome measures
Measure	5% Povidone Iodine Ophthalmic Solution n=65 sutures 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 patient received a routine antibiotic/steroid ointment to operated eye at surgery completion
Reduction of Contamination Rate Using Post-operative 5% Povidone Iodine	1.1 relative risk Interval 0.6 to 1.7	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	5% Povidone Iodine Ophthalmic Solution n=65 sutures 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 patient received a routine antibiotic/steroid ointment to operated eye at surgery completion
Identification of Bacterial Species Cultured From Suture Material Lactococcus lactis	1 number of positive bacterial isolates	—
Identification of Bacterial Species Cultured From Suture Material Staphylococcus epidermidis	40 number of positive bacterial isolates	—
Identification of Bacterial Species Cultured From Suture Material Staphylococcus lugdunensis	3 number of positive bacterial isolates	—
Identification of Bacterial Species Cultured From Suture Material Staphylococcus aureus	2 number of positive bacterial isolates	—
Identification of Bacterial Species Cultured From Suture Material Staphylococcus capitis	2 number of positive bacterial isolates	—
Identification of Bacterial Species Cultured From Suture Material Staphylococcus hominis	2 number of positive bacterial isolates	—
Identification of Bacterial Species Cultured From Suture Material Propionibacterium acnes	2 number of positive bacterial isolates	—
Identification of Bacterial Species Cultured From Suture Material Staphylococcus cohnii	1 number of positive bacterial isolates	—
Identification of Bacterial Species Cultured From Suture Material Staphylococcus warneri	1 number of positive bacterial isolates	—
Identification of Bacterial Species Cultured From Suture Material Staphylococcus xylosus	1 number of positive bacterial isolates	—
Identification of Bacterial Species Cultured From Suture Material Citrobacter koseri	1 number of positive bacterial isolates	—

Adverse Events

5% Povidone Iodine Ophthalmic Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

no Povidone-iodine Ophthalmic Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hilda Capo

University of Miami

Phone: 305-326-6555

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place