DAC®, a Hyaluronan Derivative in the Form of a Gel, Is Effective in Preventing Periprosthetic Joint Infection During Arthroplasty Revision in Patients with Comorbidities: A Retrospective, Observational, 1:1-Matched Case–Control Clinical Investigation
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Design and Patient Enrollment
2.2. DAC® Gel Coating and Standard Treatment
2.3. Assessment of PJI
2.4. Statistical Analysis
3. Results
3.1. Patients’ Baseline Characteristics
3.2. PJIs and Adverse Event Assessment
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Abbreviations
BMI | Body Mass Index |
CODP | Chronic Obstructive Pulmonary Disease |
CDC | Centers for Disease Control |
DAC® | Defensive Antibacterial Coating |
DAIR | Debridement, Antibiotics, and Implant Retention |
F | Female |
HY | Hyaluronan |
IAFF | Infection After Fracture Fixation |
M | Male |
NS | Not Significant |
PDLLA | Poly-D, L-Lactic Acid |
PJIs | Periprosthetic Joint Infections |
PLA | Poly-Lactic Acid |
PMMA | Polymethylmethacrylate |
SD | Standard Deviation |
SSI | Surgical Site Infection |
THA | Total Hip Arthroplasty |
TKA | Total Knee Arthroplasty |
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Variables | DAC® Group n = 96 | Control Group n = 96 | p-Value |
---|---|---|---|
Basic data | |||
Age, years, median (IQR) | 63 (12.5) | 63 (9) | 0.7898 ⴕ |
Gender, n male/female | 82/68 | 82/68 | 1 * |
Body mass index (kg/m2), median (IQR) | 25.6 (3.3) | 25.7 (3.1) | 0.7307 ⴕ |
Prevalent comorbidities n (%) | |||
Smoke | 19 (19.8%) | 8 (8.3%) | 0.0224 * |
Diabetes | 18 (18.8%) | 13 (13.5%) | 0.3268 * |
Obesity | 16 (16.7%) | 10 (10.4%) | 0.2057 * |
Cardiovascular disease | 10 (10.4%) | 10(10.4%) | 1 * |
Hypertension | 7 (7.3%) | 7 (7.3%) | 1 * |
CODP | 7 (7.3%) | 9 (9.4%) | 0.6015 * |
Risk factor, mean (SD) | 3.8 ± 2.3 | 4.5 ± 3.1 | 0.0768 ⴕⴕ |
Revision n (%) | |||
Hip | 78 (81.3%) | 78 (81.3%) | 1 * |
Knee | 18 (18.8%) | 18 (18.8%) | 1 * |
Septic | 5 (5.2%) | 4 (4.2%) | 0.7328 * |
Aseptic | 91 (94.7%) | 92 (95.8%) | 0.7328 * |
Length of surgery (min.), median (IQR) | 80 (20) | 90 (15) | 0.0001 ⴕ |
Variables | DAC® Group n = 96 | Control Group n = 96 | p-Value |
---|---|---|---|
3-month follow-up | |||
Follow-up (days), median (IQR) | 95 (12) | 105 (4) | 0.0001 ⴕ |
Infection n (%) | 0 | 5 (5.2%) | 0.0235 * |
Pathogen | |||
Methicillin-Susceptible S. aureus (MSSA) | - | 3 | |
S. Epidermidis | - | 1 | |
Methicillin-Resistant S. Aureus (MRSA) | - | 1 | |
Onset of infection (days), mean (SD) | 54 ± 14 | ||
Surgical wound | |||
Regular | 92 (95.8%) | 89 (93%) | 0.3515 * |
Dehiscence | 0 | 3 (3.1%) | 0.0809 * |
Exudate | 1 (1%) | 0 | 0.3160 * |
Swelling | 0 | 2 (2.1%) | 0.1551 * |
Redness | 2 (2.1%) | 1 (1%) | 0.5606 * |
Delayed wound healing | 0 | 1 (1.3%) | 0.3160 * |
Requiring advanced wound medication | 1 (1%) | 0 | 0.3160 * |
Other complications, n (%) | |||
DAIR | 0 | 2 (2.1%) | 0.1551 * |
Prolonged antibiotic therapy | 0 | 5 (5.2%) | 0.0235 * |
6 m follow-up | |||
Follow-up (days), median (IQR) | 182.5 (14) | 192 (3.5) | 0.0001 ⴕ |
Surgical wound | |||
Regular | 96 (100%) | 96 (100%) | 1 * |
Other complications, n (%) | |||
Revision (implant removal) | 0 | 3 (3.1%) | 0.0809 * |
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Ricciardi, G.; Giuliani, G.; Armando, A.; Quitadamo, R.; Demita, R.; Stigliani, C. DAC®, a Hyaluronan Derivative in the Form of a Gel, Is Effective in Preventing Periprosthetic Joint Infection During Arthroplasty Revision in Patients with Comorbidities: A Retrospective, Observational, 1:1-Matched Case–Control Clinical Investigation. Biomedicines 2025, 13, 2408. https://doi.org/10.3390/biomedicines13102408
Ricciardi G, Giuliani G, Armando A, Quitadamo R, Demita R, Stigliani C. DAC®, a Hyaluronan Derivative in the Form of a Gel, Is Effective in Preventing Periprosthetic Joint Infection During Arthroplasty Revision in Patients with Comorbidities: A Retrospective, Observational, 1:1-Matched Case–Control Clinical Investigation. Biomedicines. 2025; 13(10):2408. https://doi.org/10.3390/biomedicines13102408
Chicago/Turabian StyleRicciardi, Giuseppe, Giancarlo Giuliani, Arminio Armando, Raffaele Quitadamo, Rosario Demita, and Costantino Stigliani. 2025. "DAC®, a Hyaluronan Derivative in the Form of a Gel, Is Effective in Preventing Periprosthetic Joint Infection During Arthroplasty Revision in Patients with Comorbidities: A Retrospective, Observational, 1:1-Matched Case–Control Clinical Investigation" Biomedicines 13, no. 10: 2408. https://doi.org/10.3390/biomedicines13102408
APA StyleRicciardi, G., Giuliani, G., Armando, A., Quitadamo, R., Demita, R., & Stigliani, C. (2025). DAC®, a Hyaluronan Derivative in the Form of a Gel, Is Effective in Preventing Periprosthetic Joint Infection During Arthroplasty Revision in Patients with Comorbidities: A Retrospective, Observational, 1:1-Matched Case–Control Clinical Investigation. Biomedicines, 13(10), 2408. https://doi.org/10.3390/biomedicines13102408