Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06284174
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-21
Brief Title:
Effectiveness of Povidone-Iodine Versus Chlorhexidine Gluconate Solutions in Reducing Microbial Contamination in Spinal Surgery Wounds During Intraoperative Soaking
Sponsor:
National Cheng-Kung University Hospital
Organization:
National Cheng-Kung University Hospital
Study Overview
Official Title:
Effectiveness of Povidone-Iodine Versus Chlorhexidine Gluconate Solutions in Reducing Microbial Contamination in Spinal Surgery Wounds During Intraoperative Soaking
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to assess the efficacy of intraoperative wound irrigation with iodine-containing and chlorhexidine-containing solutions in reducing bacterial colonization during spine surgery and to determine which solution is more effective Additionally we aim to evaluate any side effects associated with the use of these two antiseptic solutions for wound irrigation
Detailed Description:
Study Background Infection is a challenging complication in spinal surgery with various methods proposed to reduce intraoperative bacterial load and subsequently lower postoperative infection rates The use of iodine-containing solutions on surgical wounds has been shown to effectively reduce infection rates after spinal surgery However some studies suggest that iodine solutions may impair fibroblast activity affecting wound healing Chlorhexidine is another effective antimicrobial agent which compared to iodine solutions has similar antimicrobial efficacy without hindering wound recovery Its use for intraoperative irrigation in joint replacement surgery has been reported to effectively reduce postoperative infections Yet evidence of its effectiveness as an irrigation solution in spine surgery is lacking and previous studies have rarely focused on intraoperative wound sampling to investigate whether irrigation solutions can effectively reduce microbial residue
Study Objective The aim of this experiment is to evaluate whether the use of iodine-containing solutions and chlorhexidine for wound irrigation before closing spinal surgery wounds can effectively reduce the positive rate of bacterial cultures and to assess which has stronger functionality and any associated side effects
Study Methods This research will include patients diagnosed with lumbar spinal stenosis causing nerve compression who are scheduled for open spinal decompression and fusion surgery Patients will be randomly assigned to one of three groups a control group soaked with 09 normal saline an iodine group soaked with 35 povidone-iodine solution and a CHG group soaked with 005 chlorhexidine gluconate All groups will receive the same surgical pre-care preoperative disinfection and prophylactic antibiotics Before wound closure each group will undergo different irrigation solutions for soaking the wound for three minutes followed by rinsing with copious saline Samples from deep and superficial tissues and implants will be taken for bacterial culture and molecular biochip analysis
Study Significance Infections in spinal surgery have a significant impact on patient outcomes and healthcare costs This study aims to confirm whether pre-wound closure soaking with antimicrobial solutions can effectively reduce bacterial load inside and outside the wound to lower the risk of postoperative infection
Study Objective The aim of this experiment is to evaluate whether the use of iodine-containing solutions and chlorhexidine for wound irrigation before closing spinal surgery wounds can effectively reduce the positive rate of bacterial cultures and to assess which has stronger functionality and any associated side effects
Study Methods This research will include patients diagnosed with lumbar spinal stenosis causing nerve compression who are scheduled for open spinal decompression and fusion surgery Patients will be randomly assigned to one of three groups a control group soaked with 09 normal saline an iodine group soaked with 35 povidone-iodine solution and a CHG group soaked with 005 chlorhexidine gluconate All groups will receive the same surgical pre-care preoperative disinfection and prophylactic antibiotics Before wound closure each group will undergo different irrigation solutions for soaking the wound for three minutes followed by rinsing with copious saline Samples from deep and superficial tissues and implants will be taken for bacterial culture and molecular biochip analysis
Study Significance Infections in spinal surgery have a significant impact on patient outcomes and healthcare costs This study aims to confirm whether pre-wound closure soaking with antimicrobial solutions can effectively reduce bacterial load inside and outside the wound to lower the risk of postoperative infection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None