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| Name | Class |
|---|---|
| Thunder Bay Regional Health Sciences Centre | OTHER |
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This study will assess the efficacy of two of the most commonly used surgical skin-preparation solutions: Chloraprep (chlorhexidine-alcohol) and Duraprep (iodine-alcohol) at eliminating bacteria from the hip site by evaluating the residual bacteria present following surgical skin-preparation.
Post-operative infections, although rare, can lead to significant patient morbidity and cost. A potential risk factor for the development of post-operative wound infection is the amount of bacterial skin flora present at the operative site at the time of surgery. Therefore, the use of an effective anti-microbial preoperative skin-preparation solution is essential in preventing the contamination of the surgical site and in turn the surgical wound.
Several different types of anti-microbial skin preparation solutions are presently used pre-operatively. However, there is currently no consensus on which solution is superior. Previous studies have investigated the efficacy of commonly used solutions in the shoulder, foot and spine, however the bacterial flora from these areas are likely different from the hip region. Thus the findings in the literature are not necessarily applicable to surgery involving the hip.
Because of the potentially devastating consequences of a surgical wound infection, ensuring effective skin preparation prior to surgery is critical. Therefore the identification of a superior skin-preparation solution for the elimination of bacterial pathogens, specific to the hip region, could potentially have considerable impact on the clinical care of patients undergoing hip arthroplasty surgery.
This study will assess the efficacy of two of the most commonly used surgical skin-preparation solutions: Chloraprep (chlorhexidine-alcohol) and Duraprep (iodine-alcohol), at eliminating bacteria from the hip site by evaluating the residual bacteria present following surgical skin-preparation.The primary outcome is as follows: positive culture rates of residual bacteria following surgical skin preparation. Secondary outcomes that will be evaluated is culture rates post-surgery (following skin closure) and acute (within 3 months) post-operative wound complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duraprep Surgical Solution | Experimental | Surgical site (hip) is prepared with Duraprep (iodine-alcohol) prior to surgery according to package instructions. |
|
| Chloraprep Surgical Solution | Experimental | Surgical site (hip) is prepared with Chloraprep (chlorhexidine-alcohol) prior to surgery according to package instructions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DuraPrep | Drug | DuraPrep surgical solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-preparation skin swab | bacterial culture rates following surgical skin preparation | 4 minutes post-skin preparation |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative skin swab | bacterial culture rates following surgery | immediately after closure of the incision, before drape is removed from operative site |
| Post-operative wound complications | wound complications at follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kurt Droll, MD | TBRHSC | Principal Investigator |
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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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| ID | Term |
|---|---|
| C515331 | DuraPrep |
| D019840 | 2-Propanol |
| D002710 | Chlorhexidine |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D020005 | Propanols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D001645 | Biguanides |
| D006146 |
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Blinding of the participants and care providers after the assignment of the intervention is not possible as the two solutions are distinct, and one creates a unique discolouration of the skin. Those performing the laboratory analysis and reporting the results of the bacterial culture of will be blind to which treatment the participant was assigned (i.e. the label will not identify which group the participant belongs to).
| ChloraPrep | Drug | ChloraPrep surgical solution |
|
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| 3 months post-surgery |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Guanidines |
| D000578 | Amidines |