Safety and Efficacy of Subdermal Betadine During Posterior Spinal Fusion
ConditionSpinal Fusion
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeUp to 26
SponsorAkron Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males and females
Undergoing primary posterior spinal fusion of the thoracic and/or lumbar spine
English Speaking
Disqualifiers
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 design
Design model
Factorial
Treatments tested in this trial
10% Povidone-Iodine Arm
Biological/VaccineA second application of surgical antisepsis with a topical povidone-iodine in the subdermal layer after making an incision.
Saline Arm
Procedure/SurgeryAn application of saline in the subdermal layer after making an incision.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: 10% Povidone-Iodine ArmActive comparator 1 intervention
Group B: Saline ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
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
Time frame
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.
Time frame
From enrollment to one year post operative.Other outcomes
1
To perform statistical correlations among locations/conditions and between treatment groups will be conducted in a generalized linear mixed model (GLMM) framework with a binomial distribution and a logit link function.
* Age * Gender * Comorbidities * Body mass index (BMI) * Operative time * Blood loss * Fusion levels * Scoliosis etiology * Curve type * Curve magnitude (Cobb angle) * Use of prophylactic antibiotics * Hospital length of stay * Complications, including readmissions and reoperations.
Time frame
From enrollment to one year post operative.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov