Hip-arthroplastywounddressingNCT02771015
Performance of Flexible Self-adherent Absorbent Dressing Coated With a Soft Silicone Layer After Hip -,Knee- Arthroplasty,Primary Spine Surgery in Comparison to a Standard Wound Dressing
A study testing Mepilex Border® and Cosmopor steril® in people with Hip-arthroplasty and Knee-arthroplasty, run by University of Cologne at 1 site in Germany.
Trial summary
Male or female subjects, 18 years and above, undergoing hip, knee or spinal surgery with an expected hospital stay for 4 days or more will be included in the trial. Individual trial duration will be for 7 days (follow-up). Two hundred subjects will be included in the trial, i.e. 100 subjects per arm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip-arthroplasty, Knee-arthroplasty, Spine Surgery
- What is being tested?
- Mepilex Border® and Cosmopor steril®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2014to May 2016
- 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
- Age ≥18years
- Have an expected total length of stay of 4 or more days
- Undergoing elective primary arthroplasty of the hip or knee or spinal surgery
- Undergoing hip surgery with a standard access
- Give their written informed consent to participate
Who cannot join
- Dressing size does not fit the incision area
- Known allergy/hypersensitivity to any of the components of the dressing
- Multi-trauma
- Undergoing arthroplasty due to tumor
- Fractures
- Wound at the surgical site prior to surgery
- Neurological deficit of operated side (hemiplegia, etc.)
- Subject has documented skin disease at time of enrolment, as judged by the investigator
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Cologne
Cologne, North Rhine-Westphalia, 50931
About this study
Official title: A Mono-centre, Post CE-mark, Prospective-randomized Clinical Trial to Evaluate the Performance of a Flexible Self-adherent Absorbent Dressing Coated With a Soft Silicone Layer After Hip or Knee Arthroplasty or Primary Spine Surgery in Comparison to a Standard Wound Dressing (Cosmopor E®Steril, Fa. Hartmann)
Male or female subjects, 18 years and above, undergoing hip, knee or spinal surgery with an expected hospital stay for 4 days or more will be included in the trial. Individual trial duration will be for 7 days (follow-up). Two hundred subjects will be included in the trial, i.e. 100 subjects per arm. The treatment arm (either new or standard wound dressing) will be assigned by randomization stratified by type of surgery (i.e. hip, knee or spine).
Read the detailed description
At the baseline visit:
- Subject demographic details
- Inclusion and exclusion criteria
- Vital signs
- Medical and surgical history
- Skin status at incision site
- Mobilisation (subject mobility, mobilisation in bed and chair)
- Medication
- AE/ADE/ SAE/SADE/DD
- Informed consent
- Randomization
At visit 2:
- Type of surgery
- Length of incision
- Intraoperative antibiotic given
- Length of anesthesia
At each visit from visit 3:
- Surgical incision condition (condition under the dressing, condition outside the dressing, exudates amount, exudates nature, wound odour, dressing capacity of handling blood, signs of systemic infection, systemic antibiotic given for the systematic infection, blistering, skin stripping
- Skin status at incision site (type of skin, skin temperature, skin perspiration, oedema, tissue consistency, sensation)
- Mobilisation (subject mobility, mobilisation in bed and chair)
- Dressing change (application and removal)
- Drainage (drainage used, application of the drainage)
- Compression Medication (pain medication and systematic antibiotic treatment)
- Photo (photo before and after dressing removal and if signs of infection)
- Investigator/nurse evaluation (ease of application of the dressing, size of the dressing, shape of the dressing, visibility beneath the dressing, notice any pain at dressing change, ease of removal of the dressing, overall experience)
- Patient evaluation (the patient's overall experience of the dressing, comfort when wearing the dressing).
- Contentious pain - measured by Visual Analog Scale (VAS) Prüfplan: CLOSE 2.0F 28.10.2013 5(40)
- Product application (time application start, time application ended, staff involved, material)
- AE/ADE/SAE/SADE/DD
- Conditions
- Hip-arthroplasty, Knee-arthroplasty, Spine Surgery
- Being tested
- Mepilex Border®, Cosmopor steril®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepilex Border®Device
randomization
Cosmopor steril®Device
randomization
| Study group | Role | What they receive |
|---|---|---|
| Mepilex Border® | Active comparator | Mepilex Border® wound dressing at patients after hip-knee or primary spine surgery Receives: Device: Mepilex Border® |
| Cosmopor steril® | Active comparator | Standard wound dressing at patients after hip-knee or primary spine surgery Receives: Device: Cosmopor steril® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimize the Risk of the Development of Blistering
Number of participants without blisters at study visit
Measured: 7 days after surgery
Secondary outcomes (4)
Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing
The comfort, conformability and the acceptability of the dressing were measured on all visit in the study, by a study nurses. The patient had to answer questions regarding, the size of the dressing, shape of the dressing, Visibility beneath the dressing, ease of the application of the dressing, ease of removal of the dressing, overall experience of the use of the dressing, notice any pain at dressing change, Comfort of their dressing, overall experience of their dressing. The patient could chose between 1 Good, 2 Very good, 3 Excellent.In most cases, the patient chose very good to excellent for both hip and knee surgery
Measured: 7 days
Comfort, Comformability, Acceptability of the Dressing
The comfort, conformability and the acceptability of the dressing were measured on all visit in the study, by a study nurses. The patient had to answer questions regarding, the size of the dressing, shape of the dressing, Visibility beneath the dressing, ease of the application of the dressing, ease of removal of the dressing, overall experience of the use of the dressing, notice any pain at dressing change, Comfort of their dressing, overall experience of their dressing. The patient could chose between 1 Good, 2 Very good, 3 Excellent
Measured: 7 days
Change From Baseline in Pain on the visual analog scale
Scores range from 0 [no pain] to 10 [worst possible pain]
Measured: 7 days
the overall cost regarding dressing wear time
bill of material costs
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startAug 2014
- Primary completionDec 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip-arthroplastyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Bredow, University of Cologne
- Investigators
- Jan Bredow, Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771015
- Sponsor's protocol ID
- Uni-Köln_2013-01
- Acronym
- wounddressing
- Status last verified
- May 2016
- First submitted
- 8 Sep 2015
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mono-centre, Post CE-mark, Prospective-randomized Clinical Trial to Evaluate the Performance of a Flexible Self-adherent Absorbent Dressing Coated With a Soft Silicone Layer After Hip or Knee Arthroplasty or Primary Spine Surgery in Comparison to a Standard Wound Dressing (Cosmopor E®Steril, Fa. Hartmann)
- ClinicalTrials.gov ID
- NCT02771015
- Acronym / sponsor ID
- wounddressing / Uni-Köln_2013-01
- Conditions
- Hip-arthroplasty, Knee-arthroplasty, Spine Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 12 May 2016 (estimated)
- 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.
Male or female subjects, 18 years and above, undergoing hip, knee or spinal surgery with an expected hospital stay for 4 days or more will be included in the trial. Individual trial duration will be for 7 days (follow-up). Two hundred subjects will be included in the trial, i.e. 100 subjects per arm. The treatment arm (either new or standard wound dressing) will be assigned by randomization stratified by type of surgery (i.e. hip, knee or spine).
Detailed description
At the baseline visit:
- Subject demographic details
- Inclusion and exclusion criteria
- Vital signs
- Medical and surgical history
- Skin status at incision site
- Mobilisation (subject mobility, mobilisation in bed and chair)
- Medication
- AE/ADE/ SAE/SADE/DD
- Informed consent
- Randomization
At visit 2:
- Type of surgery
- Length of incision
- Intraoperative antibiotic given
- Length of anesthesia
At each visit from visit 3:
- Surgical incision condition (condition under the dressing, condition outside the dressing, exudates amount, exudates nature, wound odour, dressing capacity of handling blood, signs of systemic infection, systemic antibiotic given for the systematic infection, blistering, skin stripping
- Skin status at incision site (type of skin, skin temperature, skin perspiration, oedema, tissue consistency, sensation)
- Mobilisation (subject mobility, mobilisation in bed and chair)
- Dressing change (application and removal)
- Drainage (drainage used, application of the drainage)
- Compression Medication (pain medication and systematic antibiotic treatment)
- Photo (photo before and after dressing removal and if signs of infection)
- Investigator/nurse evaluation (ease of application of the dressing, size of the dressing, shape of the dressing, visibility beneath the dressing, notice any pain at dressing change, ease of removal of the dressing, overall experience)
- Patient evaluation (the patient's overall experience of the dressing, comfort when wearing the dressing).
- Contentious pain - measured by Visual Analog Scale (VAS) Prüfplan: CLOSE 2.0F 28.10.2013 5(40)
- Product application (time application start, time application ended, staff involved, material)
- AE/ADE/SAE/SADE/DD
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mepilex Border® | Active comparator | Device: Mepilex Border®Mepilex Border® wound dressing at patients after hip-knee or primary spine surgery |
| Cosmopor steril® | Active comparator | Device: Cosmopor steril®Standard wound dressing at patients after hip-knee or primary spine surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18years
- Have an expected total length of stay of 4 or more days
- Undergoing elective primary arthroplasty of the hip or knee or spinal surgery
- Undergoing hip surgery with a standard access
- Give their written informed consent to participate
Key exclusion criteria (8 listed)
- Dressing size does not fit the incision area
- Known allergy/hypersensitivity to any of the components of the dressing
- Multi-trauma
- Undergoing arthroplasty due to tumor
- Fractures
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 |
|---|---|---|
| Mepilex Border®randomization | Device | Mepilex Border® |
| Cosmopor steril®randomization | Device | Cosmopor steril® |
Primary outcome
Minimize the Risk of the Development of Blistering
Time frame: 7 days after surgery
Number of participants without blisters at study visit
4 secondary outcomes
Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing
Time frame: 7 days
Comfort, Comformability, Acceptability of the Dressing
Time frame: 7 days
Change From Baseline in Pain on the visual analog scale
Time frame: 7 days
the overall cost regarding dressing wear time
Time frame: 7 days
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 12 May 2016.
Related trials for Hip-arthroplasty
Enrolling by invitation
Comparison of Functional Results of ADM X3-MoP Cup (Stryker) and a CoC Cup (Zimmer) in Young Patients
Arthroplasties, Hip Replacement
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Recruiting
Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator
Hip Osteoarthritis
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.
Jan Bredow principal investigator
University Hospital of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mepilex Border® and Cosmopor steril® in people with Hip-arthroplasty and Knee-arthroplasty, run by University of Cologne at 1 site in Germany.
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 5 inclusion and 8 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 12 May 2016. 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 Germany. 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?
Minimize the Risk of the Development of Blistering (time frame: 7 days after surgery). 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 12 May 2016.