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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number 2006-006575-20 |
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The current standard Swedish infection prophylaxis in colorectal surgery is intravenously administered cefuroxime and metronidazole. this combination is well studied. The disadvantages of the regimen is "collateral damage" resulting from treatment with a cephalosporine and that the combination also serves as the first line of treatment for abdominal surgical infections.
Serval Swedish surgical departments have for some years used a combination of orally administered trimethoprim-sulfamethoxazole and metronidazole.
The combination is economical and believed to be effective but hitherto the outcome have not been properly researched.
The aim of this study is to compare the efficacy of these two regimens in the prevention of infection after elective colorectal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ordinary per operative prophylaxis | Active Comparator | cefuroxime(1500mg) i.v.+ metronidazole (1500mg)i.v.given at the time point of induction of anesthesia |
|
| Per oral alternative | Experimental | Trimethoprim-sulfamethoxazole(160mg/800mg)p.o.+metronidazole (1200mg)p.o.given 06.00 am on the day of operation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trimethoprim-sulfamethoxazole + metronidazole | Drug | trimethoprim-sulfamethoxazole (160mg/800mg)p.o.+ metronidazole (1200mg)p.o. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cutaneous-,subcutaneous and intraabdominal infections | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Non infectious wound complications | 4 weeks | |
| Complications to the anastomosis | 4 weeks | |
| Adverse reaction of given drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claes Hjalmarsson, MD,PhD | Department of Surgery and Oncology, Halland Hospital Halmstad, 301 85 Halmstad, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, University hospital Sahlgrenska/Östra | Gothenburg | 416 85 | Sweden | |||
| Department of Surgery and oncology, Halland Hospital in Halmstad |
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| cefuroxime and metronidazole | Drug | cefuromime 1500mg i.v. + metronidazole 1500mg i.v. |
|
| 4 weeks |
| Other post operative infections | During hospital stay |
| Septicaemia | 4 weeks |
| Halmstad |
| 301 85 |
| Sweden |
| Department of surgery, Community Hospital i Karlskrona | Karlskrona | 371 85 | Sweden |
| Vrinnevi hospital | Norrköping | 601 82 | Sweden |
| Department of surgery | Skövde | 541 85 | Sweden |
| Department of Surgery, NU-hospitals | Uddevalla | 451 80 | Sweden |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| D008795 | Metronidazole |
| D002444 | Cefuroxime |
| ID | Term |
|---|---|
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D013843 | Thiazines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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