Clinical trial · Interventional
Occlusive Skin Closure May Reduce Wound Drainage After Tumor Hip Arthroplasty
Use of an Occlusive Skin Closure System May Reduce Post-operative Wound Drainage After Tumor Arthroplasty of the Hip
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Bone Disease of the Proximal Femur | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional wound closure | Device | — | UNRESOLVED |
| occlusive wound closure | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prineo
- description
- Skin closure with Dermabond Prineo occlusive wound closure system
- interventionNames
- Device: occlusive wound closure
- type
- ACTIVE_COMPARATOR
- label
- Staples
- description
- Skin closure with staples
- interventionNames
- Device: conventional wound closure
Primary outcomes (1)
- measure
- Wound status
- timeFrame
- Up to hospital discharge (approximately 1-2 weeks) measured in number of days from intervention
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Bone resection and endoprosthetic reconstruction for metastatic tumors of 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 DERMABONDTM PRINEOTM contraindications (see 5.1.3.) * Underlying infection * Total femur replacements * Implant revision procedures
References
Publications (0)
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