Metastatic Bone Disease of the Proximal FemurNCT03746717
Occlusive Skin Closure May Reduce Wound Drainage After Tumor Hip Arthroplasty
A study testing occlusive wound closure and conventional wound closure in people with Metastatic Bone Disease of the Proximal Femur, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Bone Disease of the Proximal Femur
- What is being tested?
- occlusive wound closure and conventional wound closure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jan 2017to 3 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read more
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)
Read the 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:
- Skin closure with the DERMABOND PRINEO Skin Closure System will lead to a decreased PWD during the early post operative period.
- Skin closure with the DERMABOND PRINEO Skin Closure System will lead to a decreased use of antibiotics during the early post operative period.
- Skin closure with the DERMABOND PRINEO Skin Closure System will lead to shorter hospital stay.
- Being tested
- occlusive wound closure, conventional wound closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occlusive wound closureDevice
skin closure with a commercially available wound closure product consisting of a synthetic adhesive mesh and cyanoacrylate based skin glue
conventional wound closureDevice
wound closure with surgical staples
| Study group | Role | What they receive |
|---|---|---|
| Prineo | Experimental | Skin closure with Dermabond Prineo occlusive wound closure system Receives: Device: occlusive wound closure |
| Staples | Active comparator | Skin closure with staples Receives: Device: conventional wound closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound status
time to dry wound status
Measured: Up to hospital discharge (approximately 1-2 weeks) measured in number of days from intervention
Secondary outcomes (1)
Antibiotic Use
time during which prophylactic antibiotics are administered
Measured: Up to hospital discharge (approximately 1-2 weeks) measured in number of days from intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start15 Jan 2017
- Primary completion21 Aug 2018
- Study completion3 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Bone Disease of the Proximal FemurStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open 2-arm prospective randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon, Inc.
- Responsible party
- Principal investigator, Werner Hettwer, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Werner H Hettwer, MD, MSc, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746717
- Sponsor's protocol ID
- PRINEO-RCT RH-MSKTS-ORTH
- Status last verified
- Nov 2018
- First submitted
- 4 Nov 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not planned to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Occlusive Skin Closure System May Reduce Post-operative Wound Drainage After Tumor Arthroplasty of the Hip
- ClinicalTrials.gov ID
- NCT03746717
- Acronym / sponsor ID
- PRINEO-RCT RH-MSKTS-ORTH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Ethicon, Inc.
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 21 Aug 2018 (actual)
- Study completion
- 3 Nov 2018 (actual)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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:
- Skin closure with the DERMABOND PRINEO Skin Closure System will lead to a decreased PWD during the early post operative period.
- Skin closure with the DERMABOND PRINEO Skin Closure System will lead to a decreased use of antibiotics during the early post operative period.
- Skin closure with the DERMABOND PRINEO Skin Closure System will lead to shorter hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open 2-arm prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Prineo | Experimental | Device: occlusive wound closureSkin closure with Dermabond Prineo occlusive wound closure system |
| Staples | Active comparator | Device: conventional wound closureSkin closure with staples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| occlusive wound closureskin closure with a commercially available wound closure product consisting of a synthetic adhesive mesh and cyanoacrylate based skin glue | Device | Prineo |
| conventional wound closurewound closure with surgical staples | Device | Staples |
Primary outcome
Wound status
Time frame: Up to hospital discharge (approximately 1-2 weeks) measured in number of days from intervention
time to dry wound status
1 secondary outcome
Antibiotic Use
Time frame: Up to hospital discharge (approximately 1-2 weeks) measured in number of days from intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Individual participant dataSharing planned: No. It is not planned to share IPD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Werner H Hettwer, MD, MSc principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing occlusive wound closure and conventional wound closure in people with Metastatic Bone Disease of the Proximal Femur, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound status (time frame: Up to hospital discharge (approximately 1-2 weeks) measured in number of days from intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018; AzTrials last refreshed its copy on 7 Nov 2026.