Metastatic Bone Disease of the Proximal Femur Clinical Trial
Official title:
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)
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.
;