Suture Contamination Rate in Adjustable Suture Strabismus Surgery

Suture Strabismus Surgery Clinical Trial

Official title:

Suture Contamination Rate in Adjustable Suture Strabismus Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02424357
• Other study ID #: 20150111
• Status: Completed
• Phase: N/A
• First received: April 20, 2015
• Last updated: November 29, 2017
• Start date: July 2015
• Est. completion date: February 2016

Study information

• Verified date: November 2017
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Strabismus
• Suture Strabismus Surgery

Intervention

Drug:
• 5%povidone iodine ophthalmic solution
one drop of 5% povidone iodine instilled into the conjunctival fornix.
• routine post-operative ophthalmic ointment
patient received a routine antibiotic/steroid ointment to operated eye at surgery completion

Locations

Country	Name	City	State
United States	Bascom Palmer Eye Institute, University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View Citation

Olitsky SE, Vilardo M, Awner S, Reynolds JD. Needle sterility during strabismus surgery. J AAPOS. 1998 Jun;2(3):151-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	48 hours
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	48 hours
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.	7 days plus 24 to 48 hours