Occlusive Skin Closure May Reduce Wound Drainage After Tumor Hip Arthroplasty

NCT03746717 | Completed

• 1 other identifier: PRINEO-RCT RH-MSKTS-ORTH
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Wound status

  time to dry wound status

  Up to hospital discharge (approximately 1-2 weeks) measured in number of days from intervention

Secondary Outcomes (1)

• Antibiotic Use

  Up to hospital discharge (approximately 1-2 weeks) measured in number of days from intervention

Other Outcomes (1)

• Hospital Stay

  Up to hospital discharge (approximately 1-2 weeks) measured in number of days from intervention

Study Arms (2)

Prineo

EXPERIMENTAL

Skin closure with Dermabond Prineo occlusive wound closure system

Device: occlusive wound closure

Staples

ACTIVE COMPARATOR

Skin closure with staples

Device: conventional wound closure

Interventions

occlusive wound closure DEVICE

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

Prineo

conventional wound closure DEVICE

wound closure with surgical staples

Staples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Ethicon, Inc.: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

Location

Study Officials

• Werner H Hettwer, MD, MSc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Orthopaedic Oncology Surgeon

Model Details: Open 2-arm prospective randomized controlled trial

Study Record Dates

• First Submitted: November 4, 2018
• First Posted: November 20, 2018
• Study Start: January 15, 2017
• Primary Completion: August 21, 2018
• Study Completion: November 3, 2018
• Last Updated: November 20, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)