Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The local application of gentamicin-containing collagen implants reduces the incidence of surgical site infections in high-risk cardiac surgery patients compared to standard prophylactic measures alone.
Surgical procedure:
(Gentamycincontaining collagen will be applied to retrosternal and between both sternal halves similar to bone wax just prior to sternal wiring (T-SHAPED. ) Control Group: Patients in this group sternum will be closed without application of local Gentamycin containing collagen.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gentamycin | Experimental | Patients in this group had local sternal Gentamycin containing collagen between two edges of the sternum |
|
| control | Active Comparator | Patients in this group sternum will be closed without application of local Gentamycin containing collagen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gentamycin | Procedure | Patients in this group had local sternal Gentamycin containing collagen between two edges of the sternum. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of infection severity (superficial and deep infections) | during first 3 months post operative | |
| Incidence of adverse effects of gentamicin implants | during first 3 months post operative | |
| Length of hospital stay | during first 3 months post operative | |
| short-term surgical outcome checklist | Reduce mediastinits and improve sternum healing in relation to different types of of sternum closure. | during first 3 months post operative |
| assess degree of healing | non contrast C.T.chest done to assess degree of healing by The 6-Point CT Score (Stacy Score): 0 Non-union No evidence of bone bridging; wide gap.
| after 3 months non contrast C.T.chest done to assess degree of healing by the Six Points Scale |
Not provided
Not provided
Inclusion Criteria:. Old age > 60 years old.
Exclusion Criteria:
o Patients with known allergies to gentamicin.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| amr tawfeek | cardiothoracic surgery department-faculty of medecine-Zagazig univeristy-Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| cardiothorathic surgery department -faculty of medecine-zagazig univeristy- Egypt | Zagazig | Sharqia Province | 44519 | Egypt |
by publication of the study
after publication of the study
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D005839 | Gentamicins |
| C055480 | bone wax |
| ID | Term |
|---|---|
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
Not provided
Not provided
Gentamycin Group: Patients in this group had local sternal Gentamycin containing collagen between two edges of the sternum.
(Gentamycincontaining collagen will be applied to retrosternal and between both sternal halves similar to bone wax just prior to sternal wiring (T-SHAPED. )
Not provided
Not provided
Not provided
| bone wax | Procedure | Patients in this group sternum will be closed without application of local Gentamycin containing collagen. |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |