Suture Strabismus SurgeryNCT02424357
Suture Contamination Rate in Adjustable Suture Strabismus Surgery
A study testing 5%povidone iodine ophthalmic solution and routine post-operative ophthalmic ointment in people with Suture Strabismus Surgery, run by University of Miami at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suture Strabismus Surgery
- What is being tested?
- 5%povidone iodine ophthalmic solution and routine post-operative ophthalmic ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All strabismus patients age ≥ 18 years scheduled for strabismus surgery with adjustable sutures at the Bascom Palmer Eye Institute will be invited to participate.
Who cannot join
- Patient who has a history of allergy to povidone-iodine.
- Disorders affecting immune function.
- Patient who is unwilling to participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Bascom Palmer Eye Institute, University of Miami
Miami, Florida, 33136
About this study
- To establish the culture positivity rate in adjustable suture strabismus surgery
- To identify bacterial species and antibiotic susceptibility patterns of microorganisms cultured from suture material
- To compare suture contamination rates with techniques to reduce the suture contamination rate
Read the 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.
- Conditions
- Suture Strabismus Surgery
- Being tested
- 5%povidone iodine ophthalmic solution, routine post-operative ophthalmic ointment
- Keywords
- Adjustable strabismus surgery, suture contamination, 5%povidone iodine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5%povidone iodine ophthalmic solutionDrug
Also called 5%Betadine ophthalmic drop
one drop of 5% povidone iodine instilled into the conjunctival fornix.
routine post-operative ophthalmic ointmentDrug
patient received a routine antibiotic/steroid ointment to operated eye at surgery completion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: 5%povidone iodine ophthalmic solution; Drug: routine post-operative ophthalmic ointment |
| no povidone-iodine ophthalmic solution | Active comparator | patient received a routine antibiotic/steroid ointment to operated eye at surgery completion Receives: Drug: routine post-operative ophthalmic ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours
Secondary outcomes (2)
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
Measured: 48 hours
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.
Measured: 7 days plus 24 to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Suture Strabismus SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilda Capo, University of Miami
- Investigators
- Hilda Capo, MD, Principal investigator, Bascom Palmer Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424357
- Sponsor's protocol ID
- 20150111
- Status last verified
- Nov 2017
- First submitted
- 20 Apr 2015
- Last updated
- 30 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22909077Olitsky 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.
PubMed 10532751Carothers 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.
PubMed 12765540Apt 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.
PubMed 7540363Rossetto 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.
PubMed 27561000
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suture Contamination Rate in Adjustable Suture Strabismus Surgery
- ClinicalTrials.gov ID
- NCT02424357
- Acronym / sponsor ID
- 20150111
- Conditions
- Suture Strabismus Surgery
- Keywords
- Adjustable strabismus surgery, suture contamination, 5%povidone iodine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Posted 30 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To establish the culture positivity rate in adjustable suture strabismus surgery
- To identify bacterial species and antibiotic susceptibility patterns of microorganisms cultured from suture material
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5% povidone iodine ophthalmic solution | Experimental | Drug: 5%povidone iodine ophthalmic solution, Drug: routine post-operative ophthalmic ointmentpatient 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 | Drug: routine post-operative ophthalmic ointmentpatient received a routine antibiotic/steroid ointment to operated eye at surgery completion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All strabismus patients age ≥ 18 years scheduled for strabismus surgery with adjustable sutures at the Bascom Palmer Eye Institute will be invited to participate.
Key exclusion criteria (3 listed)
- Patient who has a history of allergy to povidone-iodine.
- Disorders affecting immune function.
- Patient who is unwilling to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5%povidone iodine ophthalmic solutionAlso: 5%Betadine ophthalmic dropone drop of 5% povidone iodine instilled into the conjunctival fornix. | Drug | 5% povidone iodine ophthalmic solution |
| routine post-operative ophthalmic ointmentpatient received a routine antibiotic/steroid ointment to operated eye at surgery completion | Drug | 5% povidone iodine ophthalmic solution, no povidone-iodine ophthalmic solution |
Primary outcome
Suture Colonization Rate in Adjustable Suture Strabismus Surgery
Time frame: 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
2 secondary outcomes
Reduction of Contamination Rate Using Post-operative 5% Povidone Iodine
Time frame: 48 hours
Identification of Bacterial Species Cultured From Suture Material
Time frame: 7 days plus 24 to 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22909077Eustis 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.
- Background: PubMed 10532751Olitsky 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.
- Background: PubMed 12765540Carothers 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.
- Background: PubMed 7540363Apt 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.
- Derived from this study: PubMed 27561000Rossetto 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilda Capo, MD principal investigator
Bascom Palmer Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5%povidone iodine ophthalmic solution and routine post-operative ophthalmic ointment in people with Suture Strabismus Surgery, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suture Colonization Rate in Adjustable Suture Strabismus Surgery (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02424357, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.