Occlusive Skin Closure May Reduce Wound Drainage After Tumor Hip Arthroplasty

Plain-language summary

Study Type: Investigator initiated, non-significant risk Study Objective(s): To establish the effect of occlusive wound closure with the DERMABONDTM PRINEO skin closure system, compared to routine wound closure with skin staples, on post-operative wound discharge (PWD) after tumor arthroplasty of the hip Study Population: Patients with secondary tumors of bone, undergoing tumor resection and primary endoprosthetic reconstruction involving the hip joint Inclusion Criteria: * Bone resection and endoprosthetic reconstruction for metastatic bone lesions involving the proximal femur or acetabulum * Imminent, or de-facto pathologic fractures of proximal femur and/or acetabulum, requiring endoprosthetic reconstruction (with or without bone resection) involving the hip joint Exclusion Criteria: * Minors * Pregnant and breast-feeding women * Skin defects and wound conditions not amenable to primary wound closure and other DERMABOND PRINEO contraindications * Underlying infection * Total femur replacements * Implant revision procedures Structure: Open 2-arm prospective randomized controlled trial. Duration of Study: 18 -24 months Multi-center: No Masking/Blinding: No Method of Subject Assignment: Block Randomization (10 in each block) Concurrent Control: Active - wound closure with skin staples Estimated Total Sample Size: 70 subjects will be enrolled in this study Statistical Rationale Provided: Yes Statistical Methods: Student t test for unpaired data Study Endpoints: * Time to dry wound status (in post-operative days) * Duration of antibiotic use (in post-operative days) * Length of hospital stay (in post-operative days)

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