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Randomized, prospective, single-blind clinical trial comparing two static wound retractors - the Charnley retractor and the Alexis O-Ring retractor - in primary total hip arthroplasty (THA). The primary objective is to compare surgical site contamination rates between the two devices. Secondary objectives include comparison of incision length, surgical time, intraoperative skin lesions, and postoperative complications including periprosthetic joint infection. Patients will be randomized 1:1 to either retractor group. Surgical site contamination will be assessed through four intraoperative cultures taken at standardized timepoints. Follow-up will be conducted at 1 month postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alexis O-Ring retractor | Experimental |
| |
| Charnley retractor | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alexis O-Ring Wound Retractor | Device | Circular polyurethane wound retractor (Applied Medical, Rancho Santa Margarita, CA, USA). A rigid deep ring is placed beneath the fascia lata, and the polyurethane cylinder is rolled around the outer ring to retract wound edges and create a physical barrier between the skin and the surgical field. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site contamination rate | Intraoperative surgical site contamination assessed through four standardized cultures: (1) subcutaneous tissue immediately after incision, (2) deep tissue (joint capsule) before arthrotomy, (3) deep tissue after placement of definitive prosthetic components, and (4) subcutaneous tissue after retractor removal. | Intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar | Barcelona | 08024 | Spain |
No individual participant data sharing plan is foreseen for this study
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| Charnley Retractor | Device | Semi-rigid stainless steel ortostatic retractor consisting of a bow with two blades (one fixed, one adjustable). Placed around the incision at the level of the fascia lata to retract wound edges through elastic tension. Standard retractor currently used in total hip arthroplasty. |
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