Trial Outcomes & Findings for Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery (NCT NCT02527512)
NCT ID: NCT02527512
Last Updated: 2021-05-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
173 participants
Primary outcome timeframe
Cultures taken before and after irrigation during surgery
Results posted on
2021-05-10
Participant Flow
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.
Participant milestones
| Measure |
Povidone-Iodine
0.35% povidone-iodine ("Betadine")
Povidone-Iodine: Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
82
|
|
Overall Study
COMPLETED
|
77
|
76
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery
Baseline characteristics by cohort
| Measure |
Povidone-Iodine
n=77 Participants
0.35% povidone-iodine ("Betadine")
Povidone-Iodine: Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine
|
Normal Saline
n=76 Participants
Sterile sodium chloride (NaCl) solution
Normal Saline: Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.6 years
STANDARD_DEVIATION 2.39 • n=5 Participants
|
14.8 years
STANDARD_DEVIATION 2.04 • n=7 Participants
|
14.7 years
STANDARD_DEVIATION 2.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
59 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black/ African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian/ Alakan Naitive
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian/ Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown/ Refused/ Missing
|
13 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
ASA
1
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
ASA
2
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
ASA
3
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
ASA
4
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Risk Group
Low risk (idiopathic)
|
59 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Risk Group
High risk (other etiologies)
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Cultures taken before and after irrigation during surgeryAssess 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.
Outcome measures
| Measure |
Povidone-Iodine
n=77 Participants
0.35% povidone-iodine ("Betadine")
Povidone-Iodine: Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine
|
Normal Saline
n=76 Participants
Sterile sodium chloride (NaCl) solution
Normal Saline: Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter
|
Low Risk Povidone-iodine
idiopathic deformities
|
Low Risk Saline
idiopathic deformities
|
|---|---|---|---|---|
|
Culture Positivity
pre-washout · bacteria present
|
14 Participants
|
13 Participants
|
—
|
—
|
|
Culture Positivity
pre-washout · bacteria absent
|
63 Participants
|
63 Participants
|
—
|
—
|
|
Culture Positivity
post-washout · bacteria present
|
12 Participants
|
14 Participants
|
—
|
—
|
|
Culture Positivity
post-washout · bacteria absent
|
65 Participants
|
62 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Cultures taken before and after irrigation during surgeryBaseline (pre-irrigation) and post-irrigation tissue colonization rates and changes in culture positivity
Outcome measures
| Measure |
Povidone-Iodine
n=18 Participants
0.35% povidone-iodine ("Betadine")
Povidone-Iodine: Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine
|
Normal Saline
n=19 Participants
Sterile sodium chloride (NaCl) solution
Normal Saline: Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter
|
Low Risk Povidone-iodine
n=59 Participants
idiopathic deformities
|
Low Risk Saline
n=57 Participants
idiopathic deformities
|
|---|---|---|---|---|
|
Risk Groups
pre-irrigation · positive
|
2 Participants
|
3 Participants
|
12 Participants
|
10 Participants
|
|
Risk Groups
pre-irrigation · negative
|
16 Participants
|
16 Participants
|
47 Participants
|
47 Participants
|
|
Risk Groups
post-irrigation · positive
|
5 Participants
|
4 Participants
|
7 Participants
|
10 Participants
|
|
Risk Groups
post-irrigation · negative
|
13 Participants
|
15 Participants
|
52 Participants
|
47 Participants
|
Adverse Events
Povidone-Iodine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lauren Hutchinson, Clinical Research Manager
Boston Children's Hospital
Phone: 6179191632
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place