Clinical trial NCT06744907: Safety and Efficacy of Subdermal Betadine During Posterior Spinal Fusion
Official title: Subdermal Betadine to Reduce Microbacterial Bioburden During Posterior Spinal Fusion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Spinal Fusion
Keywords: Spinal Fusion
Lumbar Spine
Thoracic Spine
Subdermal Betadine
Microbacterial bioburden
Lead sponsor: Akron Children's Hospital
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 60
Sex: ALL
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria

* Males and females
* Undergoing primary posterior spinal fusion of the thoracic and/or lumbar spine
* English Speaking

Exclusion Criteria

* 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

Primary outcomes:
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).
timeFrame: From enrollment to one year post operative.
Secondary outcomes:
measure: To report the incidence of treatment-related and other adverse events, including allergic.
timeFrame: From enrollment to one year post operative.
Other outcomes:
measure: 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.
timeFrame: From enrollment to one year post operative.
Locations:
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
Study officials:
References: