Spine InfectionNCT06284174
Effectiveness of Povidone-Iodine Versus Chlorhexidine Gluconate Solutions in Reducing Microbial Contamination in Spinal Surgery Wounds During Intraoperative Soaking.
A study testing Povidone-iodine solution; chlorhexidine gluconate in people with Spine Infection, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Infection
- What is being tested?
- Povidone-iodine solution; chlorhexidine gluconate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2021to 31 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients who were diagnosed with lumbar spinal stenosis need to undergo posterior lumbar decompression with fusion surgery.
Who cannot join
- People who are allergic to disinfectants (Providine or CHG)
- The surgical site has been operated before.
- Patients under active infection status.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Wei-Ren Su, M.D., M.Sc., 886-6-2766689, suwr@ms28.hinet.net
About this study
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.
Read the 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 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 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.
- Conditions
- Spine Infection
- Being tested
- Povidone-iodine solution; chlorhexidine gluconate
- Keywords
- Spine surgery, Providine-iodine, Chlorohexidine gluconate, surgical wound infection
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-iodine solution; chlorhexidine gluconateDrug
Before wound closure, each group will undergo different irrigation solutions for soaking the wound for three minutes followed by rinsing with copious saline.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Povidone-iodine solution; chlorhexidine gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one week postoperatively.
Secondary outcomes (1)
Post operative infection
Patient develops symptomatic wound infection will be recorded
Measured: within 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Jan 2021
- Primary completion31 Dec 2024
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine InfectionStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- 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
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284174
- Sponsor's protocol ID
- B-BR-109-054-T
- Status last verified
- May 2025
- First submitted
- 21 Feb 2024
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Can share de-identified data
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Povidone-Iodine Versus Chlorhexidine Gluconate Solutions in Reducing Microbial Contamination in Spinal Surgery Wounds During Intraoperative Soaking.
- ClinicalTrials.gov ID
- NCT06284174
- Acronym / sponsor ID
- B-BR-109-054-T
- Conditions
- Spine Infection
- Keywords
- Spine surgery, Providine-iodine, Chlorohexidine gluconate, surgical wound infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: Povidone-iodine solution; chlorhexidine gluconateBefore wound closure, patients will undergo 0.9% normal saline irrigation solutions for soaking the wound for three minutes followed by rinsing with copious saline. |
| povidone-iodine group | Experimental | Drug: Povidone-iodine solution; chlorhexidine gluconateBefore wound closure, patients will undergo 3.5% povidone-iodine solutions for soaking the wound for three minutes followed by rinsing with copious saline. |
| CHG group | Experimental | Drug: Povidone-iodine solution; chlorhexidine gluconateBefore wound closure, patients will undergo 0.05% chlorhexidine gluconate (CHG) solution for soaking the wound for three minutes followed by rinsing with copious saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who were diagnosed with lumbar spinal stenosis need to undergo posterior lumbar decompression with fusion surgery.
Key exclusion criteria (3 listed)
- People who are allergic to disinfectants (Providine or CHG)
- The surgical site has been operated before.
- Patients under active infection status.
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 |
|---|---|---|
| Povidone-iodine solution; chlorhexidine gluconateBefore wound closure, each group will undergo different irrigation solutions for soaking the wound for three minutes followed by rinsing with copious saline. | Drug | CHG group, control group, povidone-iodine group |
Primary outcome
Bacteria culture and Polymerase chain reaction exam
Time frame: one week postoperatively.
Samples from deep and superficial tissues and implants will be taken for bacterial culture and PCR analysis. Positive means bacterial growth.
1 secondary outcome
Post operative infection
Time frame: within 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: Undecided. Can share de-identified data
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Povidone-iodine solution; chlorhexidine gluconate in people with Spine Infection, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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: looking for participants now, as of the sponsor's last update on 29 May 2025. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacteria culture and Polymerase chain reaction exam (time frame: one week postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2025.