Suture Contamination Rate in Adjustable Suture Strabismus Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Suture Colonization Rate in Adjustable Suture Strabismus Surgery
研究概览
简要总结
- 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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All strabismus patients age ≥ 18 years scheduled for strabismus surgery with adjustable sutures at the Bascom Palmer Eye Institute will be invited to participate.
排除标准
- •Patient who has a history of allergy to povidone-iodine.
- •Disorders affecting immune function.
- •Patient who is unwilling to participate in the study
研究组 & 干预措施
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
干预措施: 5%povidone iodine ophthalmic solution (Drug)
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
干预措施: routine post-operative ophthalmic ointment (Drug)
no povidone-iodine ophthalmic solution
patient received a routine antibiotic/steroid ointment to operated eye at surgery completion
干预措施: routine post-operative ophthalmic ointment (Drug)
结局指标
主要结局
Suture Colonization Rate in Adjustable Suture Strabismus Surgery
时间窗: 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
次要结局
- Identification of Bacterial Species Cultured From Suture Material(7 days plus 24 to 48 hours)
- Reduction of Contamination Rate Using Post-operative 5% Povidone Iodine(48 hours)
研究者
Hilda Capo
Professor of Clinical
University of Miami