Effectiveness of Povidone-Iodine Versus Chlorhexidine Gluconate Solutions in Reducing Microbial Contamination in Spinal Surgery Wounds During Intraoperative Soaking.

NCT06284174 | Recruiting DMC

• 1 other identifier: B-BR-109-054-T
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Spine Infection

Keywords

Spine surgery, Providine-iodine, Chlorohexidine gluconate, surgical wound infection

Outcome Measures

Primary Outcomes (1)

• Bacteria culture and Polymerase chain reaction exam

  Samples from deep and superficial tissues and implants will be taken for bacterial culture and PCR analysis. Positive means bacterial growth.

  one week postoperatively.

Secondary Outcomes (1)

• Post operative infection

  within 6 months after surgery

Study Arms (3)

control group

PLACEBO COMPARATOR

Before wound closure, patients will undergo 0.9% normal saline irrigation solutions for soaking the wound for three minutes followed by rinsing with copious saline.

Drug: Povidone-iodine solution; chlorhexidine gluconate

povidone-iodine group

EXPERIMENTAL

Before wound closure, patients will undergo 3.5% povidone-iodine solutions for soaking the wound for three minutes followed by rinsing with copious saline.

Drug: Povidone-iodine solution; chlorhexidine gluconate

CHG group

EXPERIMENTAL

Before wound closure, patients will undergo 0.05% chlorhexidine gluconate (CHG) solution for soaking the wound for three minutes followed by rinsing with copious saline.

Drug: Povidone-iodine solution; chlorhexidine gluconate

Interventions

Povidone-iodine solution; chlorhexidine gluconate DRUG

Before wound closure, each group will undergo different irrigation solutions for soaking the wound for three minutes followed by rinsing with copious saline.

CHG group; control group; povidone-iodine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were diagnosed with lumbar spinal stenosis need to undergo posterior lumbar decompression with fusion surgery.

You may not qualify if:

• People who are allergic to disinfectants (Providine or CHG)
• The surgical site has been operated before.
• Patients under active infection status.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan, 704, Taiwan

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomly assigned by computer to one of three groups: a control group (soaked with 0.9% normal saline), an iodine group (soaked with 3.5% povidone-iodine solution), and a CHG group (soaked with 0.05% chlorhexidine gluconate). All groups will receive the same surgical pre-care, preoperative disinfection, and prophylactic antibiotics. All patients understood the experimental process and signed the consent form. The patients did not know the group they were assigned to during the whole process. The bacterial culturers, examiners and clinical outcome assessors did not know the patient group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 0.9% normal saline), an iodine group (soaked with 3.5% povidone-iodine solution), and a CHG group (soaked with 0.05% 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 Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: January 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: May 31, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

TW (1)