Clinical Data Gentamicin Surgical Implant
CollaRx® Gentamicin Surgical Implant (excluding the US) is a perioperative surgical implant comprised of a lyophilized collagen matrix impregnated with the broad spectrum antibiotic, gentamicin (as the sulfate salt).
Mechanism of Action
CollaRx Gentamicin Surgical Implant achieves very high local concentrations of drug far in excess of the MIC (minimum inhibitory concentration) for gentamicin susceptible micro-organisms (~ 4 μg/ml), yet maintains systemic levels well below the toxicity threshold (10 to 12 μg/ml); refer to Figure 1.
Gentamicin's antibacterial action is concentration dependent and there is evidence to support that such high local concentrations (typically orders of magnitude above the MIC for the first 12 to 24 hours) can eradicate bacteria normally considered gentamicin resistant such as MRSE and MRSA. In addition to its antibacterial action, CollaRx Gentamicin Surgical Implant also benefits from the natural haemostasis and wound healing benefits of the fibrillar collagen sponge matrix.
There are at least 62 prospective clinical trials and published case reports involving more than 7,500 patients and covering various surgical procedures that support the safety and efficacy of our CollaRx Gentamicin Surgical Implant.
Figure 1: Pharmacokinetics of CollaRx Gentamicin Surgical Implant in Osteomyelitis Patients
|
Surgical Procedure |
No. of trials |
Total Patients |
|
21 |
963 |
|
|
17 |
1606 |
|
|
6 |
2614 |
|
|
5 |
117 |
|
|
3 |
1764 |
|
|
1 |
24 |
|
|
3 |
339 |
|
|
4 |
173 |
|
|
2 |
76 |
|
|
Total |
62 |
7626 |
For more information on this product, or to discuss partnership opportunities, please contact our business development team.