Table 1. Baseline Characteristics of the Patients in the WIFI Trial.
| Characteristics | No. of Patients/Total (%) | |
|---|---|---|
| Cefazolin Group (n = 228) |
Saline Group (n = 242) |
|
| Men | 93/228 (40.8) | 109/242 (45.0) |
| Age, mean (SD), y | 43.4 (14.8) | 45.0 (15.4) |
| BMI, mean (SD)a | 26.5 (5.4) | 26.8 (5.5) |
| Diabetes mellitus | 5/228 (2.2) | 7/242 (1.7) |
| Any nicotine use | 56/218 (24.6) | 62/231 (26.8) |
| Any alcohol use | 57/211 (27.0) | 65/224 (29.0) |
| Illegal drug use | 6/228 (2.6) | 10/242 (4.1) |
| SSI following ORIF | 15/222 (6.8) | 12/238 (5.0) |
| Reason for removal of orthopedic implantb | ||
| Pain | 163/228 (71.5) | 182/242 (75.2) |
| Implant failure | 7/228 (3.1) | 8/242 (3.3) |
| Functional problem | 15/228 (6.6) | 12/242 (5.0) |
| Patients request | 111/228 (48.9) | 113/242 (46.7) |
| Planned procedure | 30/228 (13.2) | 30/242 (12.4) |
| Time to removal of orthopedic implant, median (IQR), mo |
11 (7-16) | 11 (7-17) |
| Location removal of orthopedic implantc | ||
| Forefoot or midfoot | 15/228 (6.6) | 12/242 (5.0) |
| Tarsus | 30/228 (13.2) | 29/242 (12.0) |
| Ankle | 124/228 (54.4) | 149/242 (61.6) |
| Lower leg (tibia or fibula) | 59/228 (25.9) | 52/242 (21.5) |
| Type of removal of orthopedic implantb | ||
| Intramedullary nail | 28/228 (12.3) | 11/242 (4.4) |
| Syndesmotic screw | 24/228 (10.5) | 29/242 (12.0) |
| Screw only | 52/228 (22.8) | 49/242 (20.2) |
| Plate and screws | 132/228 (57.9) | 163/242 (67.4) |
| Kirschner wire | 11/228 (4.8) | 13/242 (5.4) |
| Duration of surgery, mean (SD), mind | 35.2 (18.5) | 34.8 (20.2) |
| Resident performing surgery | 167/227 (74.6) | 173/242 (71.5) |
| Tourniquet use | 28/225 (12.4) | 31/237 (13.1) |
| Incomplete removal of orthopedic implant | 170/228 (74.6) | 172/242 (71.1) |
| Preoperative quality-of-life scores, mean (95% CI) | ||
| Health-related quality of lifee | 0.71 (0.68-0.74) | 0.71 (0.68-0.75) |
| Self-reported quality of lifef | 77.92 (74.67-81.17) | 75.56 (72.67-78.45) |
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); IQR, interquartile range; ORIF, open reduction and internal fixation; SSI, surgical site infection; VAS, visual analog scale.
A BMI of 30 or higher was defined as obese. Data are missing for 20 patients in the cefazolin group and 25 patients in the saline group.
More than 1 option was possible.
The location of the orthopedic implant removal was the same as the location of the index fracture.
The duration of the surgery was from the time of incision to the time of wound closure. Data are missing for 7 patients in the cefazolin group and 44 patients in the saline group.
Measured by the EuroQol 5-Dimension 3-Level questionnaire (index range, 0-1; 1 indicates maximal health-related quality of life).
Measured using a visual analog scale score ranging from 0 (lowest self-reported state of health) to 100 (maximum self-reported state of health).