Surgical Site InfectionPhase 4NCT02527512
Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery
A Phase 4 study testing Povidone-Iodine and Normal Saline in people with Surgical Site Infection, run by Boston Children's Hospital at 2 sites in United States.
Trial summary
This study will evaluate the safety of povidone-iodine irrigation in pediatric spinal patients by collecting pre- and post-operative safety labwork. Furthermore, the efficacy of povidone-iodine and normal saline irrigation at reducing bacterial contamination of the surgical wound will be measured by collecting… Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Povidone-Iodine and Normal Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jul 2017to 12 Jul 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 3 to 18 years on day of surgery
- diagnosis of spinal deformity
- undergoing elective posterior spine multi-level instrumentation surgery
Who cannot join
- Documented renal failure
- documented allergy to iodine or shellfish
- previous spine fusion surgery
- undergoing elective posterior spine single-level instrumentation surgery
- undergoing anterior spine multi-level instrumentation surgery
- current antibiotic use.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Mercy Kansas City
Kansas City, Missouri, 64114
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Bacterial Wound Contamination Prior to Closure: Povidone-Iodine Versus Saline Irrigation in Pediatric Spine Fusion Surgery
This study will evaluate the safety of povidone-iodine irrigation in pediatric spinal patients by collecting pre- and post-operative safety labwork. Furthermore, the efficacy of povidone-iodine and normal saline irrigation at reducing bacterial contamination of the surgical wound will be measured by collecting cultures before and after irrigation.
Read the detailed description
Previous research has shown there is baseline bacterial contamination of surgical spinal wounds prior to closure. While this bacterial contamination may or may not lead to infection, recent adult studies demonstrated reduced infection rates by using povidone-iodine irrigation before closure. This study will determine the safety of using povidone-iodine irrigation in pediatric spinal patients and how effective it is at reducing bacterial contamination of the spinal surgical wound prior to closure, compared with normal saline. The investigators hypothesize povidone-iodine is both safe and effective. Understanding techniques that reduce the local bacterial load in the wound prior to closure after spinal fusion will give data to support measures that will ultimately reduce the rate of postoperative infections.
- Conditions
- Surgical Site Infection
- Being tested
- Povidone-Iodine, Normal Saline
- Keywords
- Scoliosis, Spine fusion, 0.35% povidone-iodine
- Medical subject headings
- Surgical Wound Infection, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-IodineDrug
Also called Betadine
Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine
Normal SalineOther
Also called NSS, NS or N/S
Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter
| Study group | Role | What they receive |
|---|---|---|
| Povidone-Iodine | Active comparator | 0.35% povidone-iodine ("Betadine") Receives: Drug: Povidone-Iodine |
| Normal Saline | Active comparator | Sterile sodium chloride (NaCl) solution Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Culture Positivity
Assess feasibility of a larger randomized controlled trial using significance of differences in the bacteriology and contamination rates of both treatment arms. Also measured baseline tissue colonization rates.
Measured: Cultures taken before and after irrigation during surgery
Secondary outcomes (1)
Risk Groups
Baseline (pre-irrigation) and post-irrigation tissue colonization rates and changes in culture positivity
Measured: Cultures taken before and after irrigation during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study start13 Jul 2017
- Primary completion1 Feb 2019
- Study completion12 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Boston Children's 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Glotzbecker, Boston Children's Hospital
- Investigators
- Michael Glotzbecker, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527512
- Sponsor's protocol ID
- IRB-P00015085
- Status last verified
- Apr 2021
- First submitted
- 7 Aug 2015
- Last updated
- 10 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dietz FR, Koontz FP, Found EM, Marsh JL. The importance of positive bacterial cultures of specimens obtained during clean orthopaedic operations. J Bone Joint Surg Am. 1991 Sep;73(8):1200-7.
PubMed 1890121Nandyala SV, Schwend RM. Prevalence of intraoperative tissue bacterial contamination in posterior pediatric spinal deformity surgery. Spine (Phila Pa 1976). 2013 Apr 15;38(8):E482-6. doi: 10.1097/BRS.0b013e3182893be1.
PubMed 23370682Chang FY, Chang MC, Wang ST, Yu WK, Liu CL, Chen TH. Can povidone-iodine solution be used safely in a spinal surgery? Eur Spine J. 2006 Jun;15(6):1005-14. doi: 10.1007/s00586-005-0975-6. Epub 2005 Aug 20.
PubMed 16133077Cheng MT, Chang MC, Wang ST, Yu WK, Liu CL, Chen TH. Efficacy of dilute betadine solution irrigation in the prevention of postoperative infection of spinal surgery. Spine (Phila Pa 1976). 2005 Aug 1;30(15):1689-93. doi: 10.1097/01.brs.0000171907.60775.85.
PubMed 16094267
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Wound Contamination Prior to Closure: Povidone-Iodine Versus Saline Irrigation in Pediatric Spine Fusion Surgery
- ClinicalTrials.gov ID
- NCT02527512
- Acronym / sponsor ID
- IRB-P00015085
- Conditions
- Surgical Site Infection
- Keywords
- Scoliosis, Spine fusion, 0.35% povidone-iodine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Posted 10 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety of povidone-iodine irrigation in pediatric spinal patients by collecting pre- and post-operative safety labwork. Furthermore, the efficacy of povidone-iodine and normal saline irrigation at reducing bacterial contamination of the surgical wound will be measured by collecting cultures before and after irrigation.
Detailed description
Previous research has shown there is baseline bacterial contamination of surgical spinal wounds prior to closure. While this bacterial contamination may or may not lead to infection, recent adult studies demonstrated reduced infection rates by using povidone-iodine irrigation before closure. This study will determine the safety of using povidone-iodine irrigation in pediatric spinal patients and how effective it is at reducing bacterial contamination of the spinal surgical wound prior to closure, compared with normal saline. The investigators hypothesize povidone-iodine is both safe and effective. Understanding techniques that reduce the local bacterial load in the wound prior to closure after spinal fusion will give data to support measures that will ultimately reduce the rate of postoperative infections.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Povidone-Iodine | Active comparator | Drug: Povidone-Iodine0.35% povidone-iodine ("Betadine") |
| Normal Saline | Active comparator | Other: Normal SalineSterile sodium chloride (NaCl) solution |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 3 to 18 years on day of surgery
- diagnosis of spinal deformity
- undergoing elective posterior spine multi-level instrumentation surgery
Key exclusion criteria (6 listed)
- Documented renal failure
- documented allergy to iodine or shellfish
- previous spine fusion surgery
- undergoing elective posterior spine single-level instrumentation surgery
- undergoing anterior spine multi-level instrumentation surgery
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-IodineAlso: BetadineChemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine | Drug | Povidone-Iodine |
| Normal SalineAlso: NSS, NS or N/SSolution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter | Other | Normal Saline |
Primary outcome
Culture Positivity
Time frame: Cultures taken before and after irrigation during surgery
Assess feasibility of a larger randomized controlled trial using significance of differences in the bacteriology and contamination rates of both treatment arms. Also measured baseline tissue colonization rates.
1 secondary outcome
Risk Groups
Time frame: Cultures taken before and after irrigation during surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1890121Dietz FR, Koontz FP, Found EM, Marsh JL. The importance of positive bacterial cultures of specimens obtained during clean orthopaedic operations. J Bone Joint Surg Am. 1991 Sep;73(8):1200-7.
- Background: PubMed 23370682Nandyala SV, Schwend RM. Prevalence of intraoperative tissue bacterial contamination in posterior pediatric spinal deformity surgery. Spine (Phila Pa 1976). 2013 Apr 15;38(8):E482-6. doi: 10.1097/BRS.0b013e3182893be1.
- Background: PubMed 16133077Chang FY, Chang MC, Wang ST, Yu WK, Liu CL, Chen TH. Can povidone-iodine solution be used safely in a spinal surgery? Eur Spine J. 2006 Jun;15(6):1005-14. doi: 10.1007/s00586-005-0975-6. Epub 2005 Aug 20.
- Background: PubMed 16094267Cheng MT, Chang MC, Wang ST, Yu WK, Liu CL, Chen TH. Efficacy of dilute betadine solution irrigation in the prevention of postoperative infection of spinal surgery. Spine (Phila Pa 1976). 2005 Aug 1;30(15):1689-93. doi: 10.1097/01.brs.0000171907.60775.85.
- 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.
Michael Glotzbecker, MD principal investigator
Boston Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Povidone-Iodine and Normal Saline in people with Surgical Site Infection, run by Boston Children's Hospital at 2 sites 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 6 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 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 10 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Culture Positivity (time frame: Cultures taken before and after irrigation during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02527512, which also lists 4 linked publications.
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 10 May 2021.