Spinal FusionPhase 4NCT06744907
Safety and Efficacy of Subdermal Betadine During Posterior Spinal Fusion
A Phase 4 study testing 10% Povidone-Iodine Arm and Saline Arm in people with Spinal Fusion, run by Akron Children's Hospital at 1 site in United States.
Trial summary
Bacterial in the subdermal layer of the skin, such as in hair follicles and sweat glands, may contaminate surgical wounds. The goal of this study is to learn about povidone-iodine and its ability to prevent infections specifically in patients with scoliosis receiving a spinal fusion. Read more about this study
- Who is it for?
- Ages Up to 26 years
- Conditions the study is for
- Spinal Fusion
- What is being tested?
- 10% Povidone-Iodine Arm and Saline Arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2025to 1 Jul 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Up to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females
- Undergoing primary posterior spinal fusion of the thoracic and/or lumbar spine
- English Speaking
Who cannot join
- Patients who have undergone prior spinal surgery
- Undergoing procedures other than primary posterior spinal fusion of the thoracic and/or lumbar spine (cervical fusion, anterior surgery, growth-friendly instrumentation)
- Any contraindication to povidone-iodine, including pregnancy, allergy, or prior treatment with radioiodine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subdermal Betadine to Reduce Microbacterial Bioburden During Posterior Spinal Fusion
Bacterial in the subdermal layer of the skin, such as in hair follicles and sweat glands, may contaminate surgical wounds. The goal of this study is to learn about povidone-iodine and its ability to prevent infections specifically in patients with scoliosis receiving a spinal fusion.
Read the detailed description
This is a prospective, one site, randomized controlled trial. The goal of this project is to evaluate the efficacy of subdermal 10% povidone-iodine at reducing bacterial contamination from the subdermal layer of skin during posterior spinal fusion. The primary outcome of this study will be incidence of positive bacterial growth in several layers of the surgical wound. Secondary outcomes will be complications, including allergic reactions, contact dermatitis, surgical site infection and wound complications. Finally, patient and surgical variables that can effect microbial growth will be observed.
Once identified, the surgeon and coordinators will discuss risks, benefits, advantages, and disadvantages of this study to eligible patients. If the family wishes to enroll, the patient's family and patient will be consented. And automatically randomized to either povidone-iodine vs control group (predetermined according to the statistician). All patients will follow the standardized spine pathway including standard antibiotics and skin preparation with isopropyl alcohol followed by ChloraPrepTM and sterile draping. Five bacterial cultures will be obtained throughout the spinal fusion similarly for all patients by rubbing along the entirety of the posterior spinal incision. The first two cultures will be taken before the placement of an antimicrobial adhesive drape and after the initial incision in the subdermal layer. The surgeon will be notified which group the patients are in. Patients who were randomized to the povidone-iodine group will then have three topical applications of 10% povidone-iodine along the length of the subdermis, using each of the 3 swab sticks provided from the sterile single-use packet. Patients who were randomized to the control group will then have three applications of sterile saline along the length of the subdermis, using each of the 3 swab sticks soaked in sterile saline. Following the 10% povidone-iodine or saline application, the solution will be allowed to dry at least three minutes and a third culture will be obtained. Surgical exposure will proceed in all patients, and an additional culture will be obtained along the length of the deep wound after exposure, and a final culture along the length of the deep wound just prior to wound closure. The swabs will be cultured, and the final results will be reported however, the surgeons delivering patient care will be blinded to the results to mitigate competing interests. Routine postoperative care will follow standard of care no matter the culture results. A data safety monitor will assure no correlation between culture results and infection rate.
- Conditions
- Spinal Fusion
- Being tested
- 10% Povidone-Iodine Arm, Saline Arm
- Keywords
- Spinal Fusion, Lumbar Spine, Thoracic Spine, Subdermal Betadine, Microbacterial bioburden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% Povidone-Iodine ArmBiological
A second application of surgical antisepsis with a topical povidone-iodine in the subdermal layer after making an incision.
Saline ArmProcedure or surgery
An application of saline in the subdermal layer after making an incision.
| Study group | Role | What they receive |
|---|---|---|
| 10% Povidone-Iodine Arm | Active comparator | A single-use sealed packet of three 10% povidone-iodine swabs will be opened via standard sterile technique. Three topical applications of 10% povidone-iodine along the length of the subdermis, using each of the 3 swab sticks provided from the sterile single-use packet. The solution will be allowed to dry at least three minutes. A culture will be obtained by rubbing an Eswab along the incision in the subdermis. Surgical exposure will proceed. After exposure is complete, an additional culture will be obtained with an Eswab in the deep wound. After corrective maneuvers are complete a final culture will be obtained with an Eswab just prior to wound closure. Receives: Biological: 10% Povidone-Iodine Arm |
| Saline Arm | Active comparator | Three sterile swabs will be provided for soaking in sterile saline. Three applications of sterile saline along the length of the subdermis, using each of the 3 swabs soaked in sterile saline. The solution will be allowed to dry at least three minutes. A culture will be obtained by rubbing and Eswab along the incision in the subdermis. Surgical exposure will proceed. After exposure is complete, and additional culture will be obtained with and Eswab in the deep wound. After corrective maneuvers are complete a final culture will be obtained with and Eswab just prior to wound closure. Receives: Procedure: Saline Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the incidence of bacterial growth in five layers of the surgical wound between the treatment group (10% povidone-iodine) and the control group (saline).
- The skin, along the length of the planned incision
- The subdermis before application of povidone-iodine versus control with saline
- The subdermis after application of povidone-iodine versus control with saline)
- The deep surgical wound after exposure
- The deep surgical wound after all corrective maneuvers are complete, before closure
Measured: From enrollment to one year post operative.
Secondary outcomes (1)
To report the incidence of treatment-related and other adverse events, including allergic.
Secondary outcomes will be complications, including allergic reactions, contact dermatitis, surgical site infection and wound complications.
Measured: From enrollment to one year post operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start3 Jan 2025
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FusionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akron Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorena Floccari, Akron Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744907
- Sponsor's protocol ID
- 2024-114
- Status last verified
- Oct 2026
- First submitted
- 21 Nov 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subdermal Betadine to Reduce Microbacterial Bioburden During Posterior Spinal Fusion
- ClinicalTrials.gov ID
- NCT06744907
- Acronym / sponsor ID
- 2024-114
- Conditions
- Spinal Fusion
- Keywords
- Spinal Fusion, Lumbar Spine, Thoracic Spine, Subdermal Betadine, Microbacterial bioburden
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Akron Children's HospitalUniversity, hospital or other
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 20 Dec 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.
Bacterial in the subdermal layer of the skin, such as in hair follicles and sweat glands, may contaminate surgical wounds. The goal of this study is to learn about povidone-iodine and its ability to prevent infections specifically in patients with scoliosis receiving a spinal fusion.
Detailed description
This is a prospective, one site, randomized controlled trial. The goal of this project is to evaluate the efficacy of subdermal 10% povidone-iodine at reducing bacterial contamination from the subdermal layer of skin during posterior spinal fusion. The primary outcome of this study will be incidence of positive bacterial growth in several layers of the surgical wound. Secondary outcomes will be complications, including allergic reactions, contact dermatitis, surgical site infection and wound complications. Finally, patient and surgical variables that can effect microbial growth will be observed.
Once identified, the surgeon and coordinators will discuss risks, benefits, advantages, and disadvantages of this study to eligible patients. If the family wishes to enroll, the patient's family and patient will be consented. And automatically randomized to either povidone-iodine vs control group (predetermined according to the statistician). All patients will follow the standardized spine pathway including standard antibiotics and skin preparation with isopropyl alcohol followed by ChloraPrepTM and sterile draping. Five bacterial cultures will be obtained throughout the spinal fusion similarly for all patients by rubbing along the entirety of the posterior spinal incision. The first two cultures will be taken before the placement of an antimicrobial adhesive drape and after the initial incision in the subdermal layer. The surgeon will be notified which group the patients are in. Patients who were randomized to the povidone-iodine group will then have three topical applications of 10% povidone-iodine along the length of the subdermis, using each of the 3 swab sticks provided from the sterile single-use packet. Patients who were randomized to the control group will then have three applications of sterile saline along the length of the subdermis, using each of the 3 swab sticks soaked in sterile saline. Following the 10% povidone-iodine or saline application, the solution will be allowed to dry at least three minutes and a third culture will be obtained. Surgical exposure will proceed in all patients, and an additional culture will be obtained along the length of the deep wound after exposure, and a final culture along the length of the deep wound just prior to wound closure. The swabs will be cultured, and the final results will be reported however, the surgeons delivering patient care will be blinded to the results to mitigate competing interests. Routine postoperative care will follow standard of care no matter the culture results. A data safety monitor will assure no correlation between culture results and infection rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10% Povidone-Iodine Arm | Active comparator | Biological: 10% Povidone-Iodine ArmA single-use sealed packet of three 10% povidone-iodine swabs will be opened via standard sterile technique. Three topical applications of 10% povidone-iodine along the length of the subdermis, using each of the 3 swab sticks provided from the sterile single-use packet. The solution will be allowed to dry at least three minutes. A culture will be obtained by rubbing an Eswab along the incision in the subdermis. Surgical exposure will proceed. After exposure is complete, an additional culture will be obtained with an Eswab in the deep wound. After corrective maneuvers are complete a final culture will be obtained with an Eswab just prior to wound closure. |
| Saline Arm | Active comparator | Procedure: Saline ArmThree sterile swabs will be provided for soaking in sterile saline. Three applications of sterile saline along the length of the subdermis, using each of the 3 swabs soaked in sterile saline. The solution will be allowed to dry at least three minutes. A culture will be obtained by rubbing and Eswab along the incision in the subdermis. Surgical exposure will proceed. After exposure is complete, and additional culture will be obtained with and Eswab in the deep wound. After corrective maneuvers are complete a final culture will be obtained with and Eswab just prior to wound closure. |
Who may qualify
- Ages
- Up to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Males and females
- Undergoing primary posterior spinal fusion of the thoracic and/or lumbar spine
- English Speaking
Key exclusion criteria (3 listed)
- Patients who have undergone prior spinal surgery
- Undergoing procedures other than primary posterior spinal fusion of the thoracic and/or lumbar spine (cervical fusion, anterior surgery, growth-friendly instrumentation)
- Any contraindication to povidone-iodine, including pregnancy, allergy, or prior treatment with radioiodine
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 |
|---|---|---|
| 10% Povidone-Iodine ArmA second application of surgical antisepsis with a topical povidone-iodine in the subdermal layer after making an incision. | Biological | 10% Povidone-Iodine Arm |
| Saline ArmAn application of saline in the subdermal layer after making an incision. | Procedure or surgery | Saline Arm |
Primary outcome
To compare the incidence of bacterial growth in five layers of the surgical wound between the treatment group (10% povidone-iodine) and the control group (saline).
Time frame: From enrollment to one year post operative.
1. The skin, along the length of the planned incision 2. The subdermis before application of povidone-iodine versus control with saline 3. The subdermis after application of povidone-iodine versus control with saline) 4. The deep surgical wound after exposure 5. The deep surgical wound after all corrective maneuvers are complete, before closure
1 secondary outcome
To report the incidence of treatment-related and other adverse events, including allergic.
Time frame: From enrollment to one year post operative.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 10% Povidone-Iodine Arm and Saline Arm in people with Spinal Fusion, run by Akron Children's Hospital at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 27 Oct 2026. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the incidence of bacterial growth in five layers of the surgical wound between the treatment group (10% povidone-iodine) and the control group (saline). (time frame: From enrollment to one year post operative.). 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 27 Oct 2026.