Postoperative Complications, Postoperative Infection
Conditions
Keywords
Betadine, Foot, Ankle, Nail fold, Scrub, Infection, Prevention, Postoperative
Brief summary
Infection and wound complications are the most common complications following orthopaedic foot and ankle procedures, and the infection rate following these procedures is higher than in procedures involving other areas of the body.The purpose of this randomized controlled trial is to determine whether a standard chlorhexidine prep can be augmented with a soak & scrub of the foot in dilute betadine to reduce the rate of positive cultures from the hallux nail fold prior to surgery.
Detailed description
Infection and wound complications are the most common complications following orthopaedic foot and ankle procedures, and the infection rate following these procedures is higher than in procedures involving other areas of the body. This is at least in part because the anatomy of the human foot presents inherent challenges for preoperative sterilization techniques due to the many folds and crevices associated with the toes. In particular, the nail folds of the toes are known to harbor large amounts of bacteria. A systematic review and meta-analysis of previous studies that have investigated the efficacy of various foot and ankle preparation agents (including alcohol, chlorhexidine, chloroxylenol, and iodine/iodophors) showed that no single agent or combination of agents eliminates positive culture growth to undetectable levels for all patients. Articles have suggested superiority of a chlorhexidine prep solution over other types of preps; hence, chlorhexidine prep is now considered the gold standard at many institutions. But even a chlorhexidine prepped foot has been shown to contain culturable bacteria in the nail folds in 30% of cases. The purpose of this randomized controlled trial is to determine whether a standard chlorhexidine prep can be augmented with a soak & scrub in dilute betadine to reduce the rate of positive cultures from the hallux nail fold. It is hypothesized that in comparison to feet receiving the standard chlorhexadine prep, feet receiving the standard prep plus the betadine soak & scrub will be less likely to have culture positive swabs of the hallux nail fold.
Interventions
PROCEDURESoak and Scrub
Betadine soak and scrub in addition to standard clorhexadine scrub (standard of care).
PROCEDUREClorhexadine scrub
Clorhexadine scrub (standard of care).
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
One group will be randomized to receive a betadine soak and scrub (in addition to the standard of care) prior to surgery. The control group will receive the standard of care.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥ 18 years of age 2. Patient requires a foot or ankle operative procedure 3. Patient provides informed consent
Exclusion criteria
1. Patient refuses 2. Patient is incarcerated, incapacitated, or otherwise unable to provide appropriate informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacterial Culture Growth | 1 day | Cotton swab of hallux nail fold. Culture of any microorganisms found. The results indicate the number of patients with positive bacterial culture growth. |
Countries
United States
Participant flow
Pre-assignment details
Patients were enrolled until protocol requirements were met.
Participants by arm
| Arm | Count |
|---|---|
| Control Subjects in this group will receive the standard chlorhexadine prep of the foot (standard of care) prior to surgery, and a cotton swab will be collected from the hallux nail fold.
Clorhexadine scrub: Clorhexadine scrub (standard of care). | 119 |
| Intervention In addition to the standard chlorhexadine prep of the foot prior to surgery, subjects in this group will also receive a betadine soak and scrub of the foot, and a cotton swab will be collected from the hallux nail fold.
Soak and Scrub: Betadine soak and scrub in addition to standard clorhexadine scrub (standard of care). | 123 |
| Total | 242 |
Baseline characteristics
| Characteristic | Control | Intervention | Total |
|---|---|---|---|
| Age, Continuous | 48.2 years STANDARD_DEVIATION 16.5 | 51.2 years STANDARD_DEVIATION 16.5 | 49.5 years STANDARD_DEVIATION 16.5 |
| Body mass index | 29.2 kg/m2 STANDARD_DEVIATION 6.8 | 29.3 kg/m2 STANDARD_DEVIATION 7.1 | 29.2 kg/m2 STANDARD_DEVIATION 7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 119 participants | 123 participants | 242 participants |
| Sex: Female, Male Female | 66 Participants | 69 Participants | 135 Participants |
| Sex: Female, Male Male | 53 Participants | 54 Participants | 107 Participants |
| Splint | 28 Participants | 27 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 119 | 0 / 123 |
| other Total, other adverse events | 8 / 119 | 9 / 123 |
| serious Total, serious adverse events | 0 / 119 | 0 / 123 |
Outcome results
Primary
Bacterial Culture Growth
Cotton swab of hallux nail fold. Culture of any microorganisms found. The results indicate the number of patients with positive bacterial culture growth.
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Bacterial Culture Growth | 32 Participants |
| Intervention | Bacterial Culture Growth | 33 Participants |