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

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)

Study Overview

• Status: Completed
• Conditions: Metastatic Bone Disease of the Proximal Femur
• Intervention / Treatment: Device: occlusive wound closure; Device: conventional wound closure

Detailed Description

Background:

Patients undergoing bone tumor resection and subsequent endoprosthetic reconstruction are at significant risk of developing prosthetic joint infection (PJI)Additionally, numerous factors contribute to a significant predisposition of these patients to wound healing complications, including the burden of their primary disease, associated comorbidities, previous or ongoing treatment often involving chemotherapy and or radiotherapy, and the extent of the necessary surgical procedure. In a retrospective review of this specific patient population treated at the investigators institution during recent years, the investigators have found a very high prevalence of persistent discharge from the surgical wound, when routine wound closure with skin staples was used. This is of particular concern, as an association of this post-operative complication with a higher incidence of PJI has been clearly established in several large studies on conventional total hip arthroplasty. Another previous study showed that prolonged wound discharge (PWD) will often lead to increased length of hospital stay and increased use of antibiotics to prevent infection. In the same study, the investigators were able to demonstrate a substantial reduction of PWD, use of intra-venous antibiotics and length of hospital stay, with use of an alternative skin closure method, combining intradermal suture and Steristrips for optimal wound edge apposition and a topical skin adhesive (2-octyl cyanoacrylate) as a sealant. However, more extensive data on the prevalence of persistent surgical wound discharge and the preventive effect of skin adhesives as an adjunct to wound closure in high-risk patient populations are lacking in the literature.

Investigational Product:

The DERMABOND PRINEO Skin Closure System has been specifically developed with the goal to achieve fast and secure closure of long incisions. It consists of two components, a pressure sensitive adhesive (PSA) initiated flexible mesh, designed for wound edge approximation and a cyanoacrylate based topical skin adhesive for occlusive wound closure. Intradermal suture is not necessary, as this system has been shown to support wound closure strength equivalent to subcuticular 3-0 sutures and is able to provide even distribution of tension across the entire incision length to ensure wound edge approximation throughout the wound healing process. Furthermore, compared to subcuticular suture, it has demonstrated equivalent wound healing and cosmesis at 90 days, while reducing wound closure time by up to 70%. It also provides an immediately effective occlusive barrier with documented antimicrobial properties, enabling patients to shower directly following a procedure and can be easily removed after the patient's natural wound healing process is complete, estimated at anywhere between 12 to 25 days.

Aims of this study:

The investigators aim to evaluate wound closure with the DERMABOND PRINEO Skin Closure System in comparison to conventional wound closure with staples in 70 patients undergoing endoprosthetic joint replacement surgery for a metastatic bone tumor, involving the proximal femur or acetabular region, in a prospective randomized study and hypothesize that:

1. Skin closure with the DERMABOND PRINEO Skin Closure System will lead to a decreased PWD during the early post operative period.
2. Skin closure with the DERMABOND PRINEO Skin Closure System will lead to a decreased use of antibiotics during the early post operative period.
3. Skin closure with the DERMABOND PRINEO Skin Closure System will lead to shorter hospital stay.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Region Hovedstaden
    • Copenhagen, Region Hovedstaden, Denmark, 2100
      • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prineo; Skin closure with Dermabond Prineo occlusive wound closure system	Device: occlusive wound closure; skin closure with a commercially available wound closure product consisting of a synthetic adhesive mesh and cyanoacrylate based skin glue
Active Comparator: Staples; Skin closure with staples	Device: conventional wound closure; wound closure with surgical staples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound status	time to dry wound status	Up to hospital discharge (approximately 1-2 weeks) measured in number of days from intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotic Use	time during which prophylactic antibiotics are administered	Up to hospital discharge (approximately 1-2 weeks) measured in number of days from intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Stay	time to discharge from hospital	Up to hospital discharge (approximately 1-2 weeks) measured in number of days from intervention

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Ethicon, Inc.
• Investigators: Principal Investigator: Werner H Hettwer, MD, MSc, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2017
• Primary Completion (Actual): August 21, 2018
• Study Completion (Actual): November 3, 2018

Study Registration Dates

• First Submitted: November 4, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): November 20, 2018
• Last Update Submitted That Met QC Criteria: November 15, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases
• Other Study ID Numbers: PRINEO-RCT RH-MSKTS-ORTH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: It is not planned to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No