Hip Surgery CorrectiveMxBPo02NCT02653183
Prospective, Randomized Clinical Investigation of Two Different Postoperative Wound Dressings
A study testing Active Comparator: Aquacel Surgical and Experimental: Mepilex Border Post-Op in people with Hip Surgery Corrective and Knee Injuries, run by Molnlycke Health Care AB at 3 sites in 2 countries.
Trial summary
The primary objective of this investigation is to evaluate if complications related to surgical wound are more common in the treatment group compared to the control group starting from operation day until last visit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Surgery Corrective, Knee Injuries
- What is being tested?
- Active Comparator: Aquacel Surgical and Experimental: Mepilex Border Post-Op
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Dec 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age ≥ 18 years
- Have an expected total length of stay of 4 postoperative days or more
- Plan for elective primary arthroplasty of the hip or knee
- Plan for incision size > 18 cm
- Give their written informed consent to participate
- 1. Undergoing elective primary arthroplasty of the hip or knee
Who cannot join
- Known allergy or hypersensitivity to any of the components of the dressings
- Multitrauma
- Undergoing arthroplasty due to tumour
- Wound at the surgical site prior to surgery
- Neurological deficit of operated side ,hemiplegia, etc.
- Documented skin disease at time of enrolment, as judged by the investigator
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- Previously enrolled in the present investigation
- Included in another ongoing investigation at present which can interfere with the result of the dressing, judged by the investigator
- Involvement in the planning and conduct of the clinical investigation, applies to all Molnlycke Health Care staff, investigational site staff and third party vendor.
- Dressing size does not fit the incision area, over 18 cm
- Complications that would increase wound risks if investigation dressing is applied
- Postoperative drain
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Belgium2 sites
University Hospital Gent, Belgium
Ghent, 9000 Gent
Medisch Centrum Latem
Sint-Martens-Latem, 9830
About this study
Official title: A Prospective, Randomized, Controlled Clinical Investigation, Comparing Two Postoperative Wound Dressings Used After Elective Hip and Knee Replacement
The primary objective of this investigation is to evaluate if complications related to surgical wound are more common in the treatment group compared to the control group starting from operation day until last visit.
The secondary objectives are to evaluate:
- the performance of the dressing
- the comfort, conformability and the acceptability of the dressing
- pain before and during dressing removal on the last visit
Read the detailed description
A prospective, randomized clinical investigation will be conducted at two to three sites in Belgium and Sweden.
Male or female, 18 years and older undergoing primary hip or knee arthroplasty with an expected hospital stay of 4 days or longer will be included in to the clinical investigation.
100 evaluable patients (i.e. 50 subjects per arm). The treatment arm (either Mepilex Border Post-Op or Aquacel Surgical) Patient eligibility will be established before treatment randomization. Patients will be randomized using optimal allocation (minimization) balancing for the following baseline variables type of surgery (hip or knee), age and skin status. Eligible patients will be randomized to receive Mepilex Border Post-Op or Aquacel surgical in a ratio of 1:1 provided.
- Conditions
- Hip Surgery Corrective, Knee Injuries
- Being tested
- Active Comparator: Aquacel Surgical, Experimental: Mepilex Border Post-Op
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: Aquacel SurgicalDevice
Post-operative all-in-one self-adherent soft silicone coated foam dressing. Duration of treatment: Total 5 days included the day of surgery and 4 post-operative days.
Experimental: Mepilex Border Post-OpDevice
Aquacel Surgical is a sterile, one piece post-operative dressing.Duration of treatment:
Total 5 days included the day of surgery and 4 post-operative days.
| Study group | Role | What they receive |
|---|---|---|
| Device Aquacel Surgical | Active comparator | Aquacel Surgical is a sterile, one piece post-operative dressing from Convatec.
Duration of treatment:
Total 5 days included the day of surgery and 4 post-operative days. Receives: Device: Experimental: Mepilex Border Post-Op |
| Device Mepilex Border Post-Op | Experimental | Post-operative all-in-one self-adherent soft silicone coated foam dressing.
Duration of treatment:
Total 5 days included the day of surgery and 4 post-operative days. Receives: Device: Active Comparator: Aquacel Surgical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing
Scale range from 0 (no dressing failure) to 7 ( complete dressing failure).
Measured: 0-5 days
Secondary outcomes (7)
Dressings Adherence to the Staples/Sutures
Dressings adherence to the staples/sutures? Yes/No
Measured: 0-5 days
Itching Feeling Under the Dressing
Itching feeling under the dressing? Yes/No
Measured: 0-5 days
Patients Satisfaction With Wearing the Dressing
4 point rating scale ( poor, good, very good,excellent)
Measured: 0-5 days
Nurses/Doctors Satisfaction With Applying the Dressing
4 point rating scale ( poor, good, very good,excellent)
Measured: 0-5 days
Patients Mobility After Operation
4 point rating scale ( poor, good, very good,excellent)
Measured: 0-5 days
Local/Systemic Infection
Local/systemic infection? Yes/No
Measured: 0-5 days
Pain Level Before and During Dressing Removal
Different adhesive on the dressings, can any difference be identified during dressing removal.
Pain level before dressing removal and pain level during dressing removal. Only measured on the last visit, with this point, the patient has not so much pain from the hip/knee joint replacement, which can have an effect on the result of dressing removal pain VAS scale (0-100 mm) 0= No pain, 100= Moste intense pain imainable.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hip Surgery CorrectiveStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653183
- Sponsor's protocol ID
- MxB Po 02
- Acronym
- MxBPo02
- Status last verified
- Sep 2017
- First submitted
- 11 Dec 2015
- Last updated
- 1 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Clinical Investigation, Comparing Two Postoperative Wound Dressings Used After Elective Hip and Knee Replacement
- ClinicalTrials.gov ID
- NCT02653183
- Acronym / sponsor ID
- MxBPo02 / MxB Po 02
- Conditions
- Hip Surgery Corrective, Knee Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Posted 1 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this investigation is to evaluate if complications related to surgical wound are more common in the treatment group compared to the control group starting from operation day until last visit.
The secondary objectives are to evaluate:
- the performance of the dressing
- the comfort, conformability and the acceptability of the dressing
- pain before and during dressing removal on the last visit
Detailed description
A prospective, randomized clinical investigation will be conducted at two to three sites in Belgium and Sweden.
Male or female, 18 years and older undergoing primary hip or knee arthroplasty with an expected hospital stay of 4 days or longer will be included in to the clinical investigation.
100 evaluable patients (i.e. 50 subjects per arm). The treatment arm (either Mepilex Border Post-Op or Aquacel Surgical) Patient eligibility will be established before treatment randomization. Patients will be randomized using optimal allocation (minimization) balancing for the following baseline variables type of surgery (hip or knee), age and skin status. Eligible patients will be randomized to receive Mepilex Border Post-Op or Aquacel surgical in a ratio of 1:1 provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device Aquacel Surgical | Active comparator | Device: Experimental: Mepilex Border Post-OpAquacel Surgical is a sterile, one piece post-operative dressing from Convatec. Duration of treatment: Total 5 days included the day of surgery and 4 post-operative days. |
| Device Mepilex Border Post-Op | Experimental | Device: Active Comparator: Aquacel SurgicalPost-operative all-in-one self-adherent soft silicone coated foam dressing. Duration of treatment: Total 5 days included the day of surgery and 4 post-operative days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Have an expected total length of stay of 4 postoperative days or more
- Plan for elective primary arthroplasty of the hip or knee
- Plan for incision size > 18 cm
- Give their written informed consent to participate
Key exclusion criteria (12 listed)
- Known allergy or hypersensitivity to any of the components of the dressings
- Multitrauma
- Undergoing arthroplasty due to tumour
- Wound at the surgical site prior to surgery
- Neurological deficit of operated side ,hemiplegia, etc.
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 |
|---|---|---|
| Active Comparator: Aquacel SurgicalPost-operative all-in-one self-adherent soft silicone coated foam dressing. Duration of treatment: Total 5 days included the day of surgery and 4 post-operative days. | Device | Device Mepilex Border Post-Op |
| Experimental: Mepilex Border Post-OpAquacel Surgical is a sterile, one piece post-operative dressing.Duration of treatment: Total 5 days included the day of surgery and 4 post-operative days. | Device | Device Aquacel Surgical |
Primary outcome
Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing
Time frame: 0-5 days
Scale range from 0 (no dressing failure) to 7 ( complete dressing failure).
7 secondary outcomes
Dressings Adherence to the Staples/Sutures
Time frame: 0-5 days
Itching Feeling Under the Dressing
Time frame: 0-5 days
Patients Satisfaction With Wearing the Dressing
Time frame: 0-5 days
Nurses/Doctors Satisfaction With Applying the Dressing
Time frame: 0-5 days
Patients Mobility After Operation
Time frame: 0-5 days
Local/Systemic Infection
Time frame: 0-5 days
Pain Level Before and During Dressing Removal
Time frame: Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator: Aquacel Surgical and Experimental: Mepilex Border Post-Op in people with Hip Surgery Corrective and Knee Injuries, run by Molnlycke Health Care AB at 3 sites in 2 countries.
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 6 inclusion and 12 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 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Sweden. 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?
Yes. Results are posted in the registry (first posted 1 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing (time frame: 0-5 days). 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 1 Jul 2019.