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The majority of elderly patients with a displaced fracture of the proximal femur are now treated with a hemiarthroplasty. Prosthetic joint infection is a devastating complication, and the infection rate is high in this group of elderly patients. Local application of gentamicin produces high antibiotic concentrations in the wound. The aim of this study is to determine whether locally administered collagen-gentamicin in the joint perioperatively in addition to routine IV prophylaxis with beta-lactam antibiotics can reduce the early postoperative infection rate (< 4 weeks postoperative)after hemiarthroplasty in proximal femoral fractures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collagen-gentamicin sponges | Active Comparator | Two sponges of collagen-gentamicin will be inserted into the hip immediately before closure of the wound. Each sponge (10 by 10 cm) contains 280 mg of collagen and 130 mg of gentamicin. |
|
| No intervention | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagen-gentamicin sponge | Device | A 10 by 10 cm sponge consisting of 280 mg collagen and 130 mg gentamicin.Two sponges are inserted during hemiarthroplasty surgery, one in the joint and one underneath the fascia at the time of surgical closure. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with postoperatively infection after hemiarthroplasty to evaluate locally administered collagen-gentamicin peroperatively | A randomized multicentre trial | Within 4 weeks after prosthetic surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Finnur Snorrason, Ph.D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buskerud Hospital, Drammen | Drammen | Drammen | 3004 | Norway | ||
| Elverum Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25737375 | Derived | Westberg M, Frihagen F, Brun OC, Figved W, Grogaard B, Valland H, Wangen H, Snorrason F. Effectiveness of gentamicin-containing collagen sponges for prevention of surgical site infection after hip arthroplasty: a multicenter randomized trial. Clin Infect Dis. 2015 Jun 15;60(12):1752-9. doi: 10.1093/cid/civ162. Epub 2015 Mar 3. |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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|
| Elverum |
| Elverum |
| 2408 |
| Norway |
| Oslo University Hospital, Ullevål | Oslo | Oslo | 0407 | Norway |
| Asker and Bærum Hospital | Bærum | Rud | 1309 | Norway |
| Diakonhjemmets Hospital | Oslo | 0784 | Norway |
| D013568 |
| Pathological Conditions, Signs and Symptoms |