Surgical Site Infection
Conditions
Keywords
Scoliosis, Spine fusion, 0.35% povidone-iodine
Brief 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 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.
Interventions
DRUGPovidone-Iodine
Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine
OTHERNormal Saline
Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 3 to 18 years on day of surgery 2. diagnosis of spinal deformity 3. undergoing elective posterior spine multi-level instrumentation surgery
Exclusion criteria
1. Documented renal failure 2. documented allergy to iodine or shellfish 3. previous spine fusion surgery 4. undergoing elective posterior spine single-level instrumentation surgery 5. undergoing anterior spine multi-level instrumentation surgery 6. current antibiotic use.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Culture Positivity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk Groups | Cultures taken before and after irrigation during surgery | Baseline (pre-irrigation) and post-irrigation tissue colonization rates and changes in culture positivity |
Countries
United States
Participant flow
Pre-assignment details
There were 6 patients that were ineligible after enrollment and were excluded prior to group assignment. The reasons included: fused fewer levels than planned(\< 6 levels), surgeon forgot to take swap samples, excessive bleeding and transfusion, put on antibiotic after enrollment and one family asked to be removed after enrollment. Thus, a total of 167 subjects were assigned to treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Povidone-Iodine 0.35% povidone-iodine (Betadine)
Povidone-Iodine: Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine | 77 |
| Normal Saline Sterile sodium chloride (NaCl) solution
Normal Saline: Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter | 76 |
| Total | 153 |
Baseline characteristics
| Characteristic | Total | Normal Saline | Povidone-Iodine |
|---|---|---|---|
| Age, Continuous | 14.7 years STANDARD_DEVIATION 2.28 | 14.8 years STANDARD_DEVIATION 2.04 | 14.6 years STANDARD_DEVIATION 2.39 |
| ASA 1 | 43 Participants | 20 Participants | 23 Participants |
| ASA 2 | 68 Participants | 34 Participants | 34 Participants |
| ASA 3 | 41 Participants | 22 Participants | 19 Participants |
| ASA 4 | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race American Indian/ Alakan Naitive | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 3 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Black/ African American | 9 Participants | 5 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian/ Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Unknown/ Refused/ Missing | 33 Participants | 20 Participants | 13 Participants |
| Race/Ethnicity, Customized Race White | 108 Participants | 49 Participants | 59 Participants |
| Risk Group High risk (other etiologies) | 37 Participants | 19 Participants | 18 Participants |
| Risk Group Low risk (idiopathic) | 116 Participants | 57 Participants | 59 Participants |
| Sex: Female, Male Female | 122 Participants | 60 Participants | 62 Participants |
| Sex: Female, Male Male | 31 Participants | 16 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 77 | 0 / 76 |
| other Total, other adverse events | 0 / 77 | 0 / 76 |
| serious Total, serious adverse events | 0 / 77 | 0 / 76 |
Outcome results
Primary
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.
Time frame: Cultures taken before and after irrigation during surgery
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Povidone-Iodine | Culture Positivity | pre-washout | bacteria present | 14 Participants |
| Povidone-Iodine | Culture Positivity | pre-washout | bacteria absent | 63 Participants |
| Povidone-Iodine | Culture Positivity | post-washout | bacteria present | 12 Participants |
| Povidone-Iodine | Culture Positivity | post-washout | bacteria absent | 65 Participants |
| Normal Saline | Culture Positivity | post-washout | bacteria absent | 62 Participants |
| Normal Saline | Culture Positivity | pre-washout | bacteria present | 13 Participants |
| Normal Saline | Culture Positivity | post-washout | bacteria present | 14 Participants |
| Normal Saline | Culture Positivity | pre-washout | bacteria absent | 63 Participants |
Secondary
Risk Groups
Baseline (pre-irrigation) and post-irrigation tissue colonization rates and changes in culture positivity
Time frame: Cultures taken before and after irrigation during surgery
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Povidone-Iodine | Risk Groups | pre-irrigation | positive | 2 Participants |
| Povidone-Iodine | Risk Groups | pre-irrigation | negative | 16 Participants |
| Povidone-Iodine | Risk Groups | post-irrigation | negative | 13 Participants |
| Povidone-Iodine | Risk Groups | post-irrigation | positive | 5 Participants |
| Normal Saline | Risk Groups | pre-irrigation | positive | 3 Participants |
| Normal Saline | Risk Groups | pre-irrigation | negative | 16 Participants |
| Normal Saline | Risk Groups | post-irrigation | positive | 4 Participants |
| Normal Saline | Risk Groups | post-irrigation | negative | 15 Participants |
| Low Risk Povidone-iodine | Risk Groups | post-irrigation | positive | 7 Participants |
| Low Risk Povidone-iodine | Risk Groups | pre-irrigation | positive | 12 Participants |
| Low Risk Povidone-iodine | Risk Groups | post-irrigation | negative | 52 Participants |
| Low Risk Povidone-iodine | Risk Groups | pre-irrigation | negative | 47 Participants |
| Low Risk Saline | Risk Groups | pre-irrigation | positive | 10 Participants |
| Low Risk Saline | Risk Groups | post-irrigation | positive | 10 Participants |
| Low Risk Saline | Risk Groups | pre-irrigation | negative | 47 Participants |
| Low Risk Saline | Risk Groups | post-irrigation | negative | 47 Participants |