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Occlusive Skin Closure May Reduce Wound Drainage After Tumor Hip Arthroplasty

NCT03746717 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2018-11-20

No results posted yet for this study

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)

Conditions

  • Metastatic Bone Disease of the Proximal Femur

Interventions

DEVICE

occlusive wound closure

skin closure with a commercially available wound closure product consisting of a synthetic adhesive mesh and cyanoacrylate based skin glue

DEVICE

conventional wound closure

wound closure with surgical staples

Sponsors & Collaborators

  • Ethicon, Inc.

    collaborator INDUSTRY

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Werner H Hettwer, MD, MSc · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-15
Primary Completion
2018-08-21
Completion
2018-11-03

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03746717 on ClinicalTrials.gov