Hip-surgeryCloseNCT01988818
Prospective, Randomized Study of 2 Different Wound Dressings
A study testing Mepilex® Border Post-Op and standard wound dressing in people with Hip-surgery and Knee-surgery, run by University of Cologne at 1 site in Germany.
Trial summary
The primary objective of this investigation is to evaluate the performance of a self-adhesive absorbent post-operative dressing coated with a soft silicone layer in minimize the risk of the development of blistering in subjects after hip or knee arthroplasty or spinal surgery in comparison to a standard wound dressing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip-surgery, Knee-surgery, Spinal-surgery
- What is being tested?
- Mepilex® Border Post-Op and standard wound dressing
- 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
- Apr 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 or spine surgery due to tumour or infection?
- 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.
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)
The primary objective of this investigation is to evaluate the performance of a self-adhesive absorbent post-operative dressing coated with a soft silicone layer in minimize the risk of the development of blistering in subjects after hip or knee arthroplasty or spinal surgery in comparison to a standard wound dressing The secondary objectives are to evaluate:
- the performance of the dressing
- the comfort, conformability and the acceptability of the dressing
- pain before, during and after dressing removal
- the overall cost regarding dressing wear time, time to do dressing change and personal resources needed
Read the detailed description
A monocentre, post CE-mark, randomized clinical trial will be conducted at the University of Cologne, Department of Orthopedics and Trauma Surgery.
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).
AEs/ADEs/unexpected events with the device may be documented by relevant photos at time. All photos shall include a sticker marked with subject code, visit number/date and time.
Outcome Measures
Primary variable:
- Development of blistering from day 0 to day 6 post surgery Photo documentation will be evaluated in a blinded manner by the Clinical Evaluation Committee (CEC).
Secondary variables:
- Other wound complications (i.e. leakage, inflammation, infection)
- Number of dressing changes
- Pain before, during and after dressing removal (VA scale)
- Performance and acceptability of the dressing (4 point rating scale)
- Conditions
- Hip-surgery, Knee-surgery, Spinal-surgery
- Being tested
- Mepilex® Border Post-Op, standard wound dressing
- Keywords
- wound dressing, silicone, standard wound dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepilex® Border Post-OpDevice
Also called Mepilex® Border Post-Op with Safetac®Technology
wound dressing with Mepilex® Border Post-Op with Safetac®Technology, self-adherent soft silicone surgical dressing
standard wound dressingDevice
Also called As comparator will be used a standard Cosmopor E®adhesive, island wound dressing (Paul Hartmann LTD)
standard wound dressing after hip-knee or spinal surgery
| Study group | Role | What they receive |
|---|---|---|
| Standard wound dressing | Active comparator | As comparator will be used a standard Cosmopor E®adhesive, island wound dressing (Paul Hartmann LTD)after hip or knee arthroplasty or spinal surgery Receives: Device: standard wound dressing |
| Mepilex® Border Post-Op | Experimental | wound dressing with Mepilex® Border Post-Op with Safetac®Technology, self-adherent soft silicone surgical dressing Receives: Device: Mepilex® Border Post-Op |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blistering
Development of blistering from day 0 to day 6 post surgery Photo documentation will be evaluated in a blinded manner by the Clinical Evaluation Committee (CEC).
Measured: 0-6 days
Secondary outcomes (4)
wound complications
Other wound complications (i.e. leakage, inflammation, infection)
Measured: 0-6 days
dressing changes
Number of dressing changes
Measured: 0-6 days
pain
Pain before, during and after dressing removal (VA scale)
Measured: 0-6 days
performance and acceptability
Performance and acceptability of the dressing (4 point rating scale)
Measured: 0-6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startApr 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip-surgeryStudies 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
- 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, physician, Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988818
- Sponsor's protocol ID
- Uni-Köln_2013-02
- Other IDs
- University Hospital Cologne
- Acronym
- Close
- Status last verified
- May 2016
- First submitted
- 13 Nov 2013
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bredow J, Hoffmann K, Oppermann J, Hellmich M, Eysel P, Zarghooni K. Evaluation of Absorbent Versus Conventional Wound Dressing. Dtsch Arztebl Int. 2018 Mar 30;115(13):213-219. doi: 10.3238/arztebl.2018.0213.
PubMed 29669676Bredow J, Oppermann J, Hoffmann K, Hellmich M, Wenk B, Simons M, Eysel P, Zarghooni K. Clinical trial to evaluate the performance of a flexible self-adherent absorbent dressing coated with a soft silicone layer compared to a standard wound dressing after orthopedic or spinal surgery: study protocol for a randomized controlled trial. Trials. 2015 Mar 7;16:81. doi: 10.1186/s13063-015-0599-z.
PubMed 25873529
Study at a glance
From the registry record, last updated by the sponsor on 11 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
- NCT01988818
- Acronym / sponsor ID
- Close / Uni-Köln_2013-02
- Conditions
- Hip-surgery, Knee-surgery, Spinal-surgery
- Keywords
- wound dressing, silicone, standard wound dressing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 20 Nov 2013 (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.
The primary objective of this investigation is to evaluate the performance of a self-adhesive absorbent post-operative dressing coated with a soft silicone layer in minimize the risk of the development of blistering in subjects after hip or knee arthroplasty or spinal surgery in comparison to a standard wound dressing The secondary objectives are to evaluate:
- the performance of the dressing
- the comfort, conformability and the acceptability of the dressing
- pain before, during and after dressing removal
- the overall cost regarding dressing wear time, time to do dressing change and personal resources needed
Detailed description
A monocentre, post CE-mark, randomized clinical trial will be conducted at the University of Cologne, Department of Orthopedics and Trauma Surgery.
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).
AEs/ADEs/unexpected events with the device may be documented by relevant photos at time. All photos shall include a sticker marked with subject code, visit number/date and time.
Outcome Measures
Primary variable:
- Development of blistering from day 0 to day 6 post surgery Photo documentation will be evaluated in a blinded manner by the Clinical Evaluation Committee (CEC).
Secondary variables:
- Other wound complications (i.e. leakage, inflammation, infection)
- Number of dressing changes
- Pain before, during and after dressing removal (VA scale)
- Performance and acceptability of the dressing (4 point rating scale)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard wound dressing | Active comparator | Device: standard wound dressingAs comparator will be used a standard Cosmopor E®adhesive, island wound dressing (Paul Hartmann LTD)after hip or knee arthroplasty or spinal surgery |
| Mepilex® Border Post-Op | Experimental | Device: Mepilex® Border Post-Opwound dressing with Mepilex® Border Post-Op with Safetac®Technology, self-adherent soft silicone surgical dressing |
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 or spine surgery due to tumour or infection?
- 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 Post-OpAlso: Mepilex® Border Post-Op with Safetac®Technologywound dressing with Mepilex® Border Post-Op with Safetac®Technology, self-adherent soft silicone surgical dressing | Device | Mepilex® Border Post-Op |
| standard wound dressingAlso: As comparator will be used a standard Cosmopor E®adhesive, island wound dressing (Paul Hartmann LTD)standard wound dressing after hip-knee or spinal surgery | Device | Standard wound dressing |
Primary outcome
Blistering
Time frame: 0-6 days
Development of blistering from day 0 to day 6 post surgery Photo documentation will be evaluated in a blinded manner by the Clinical Evaluation Committee (CEC).
4 secondary outcomes
wound complications
Time frame: 0-6 days
dressing changes
Time frame: 0-6 days
pain
Time frame: 0-6 days
performance and acceptability
Time frame: 0-6 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 11 May 2016.
- Derived from this study: PubMed 29669676Bredow J, Hoffmann K, Oppermann J, Hellmich M, Eysel P, Zarghooni K. Evaluation of Absorbent Versus Conventional Wound Dressing. Dtsch Arztebl Int. 2018 Mar 30;115(13):213-219. doi: 10.3238/arztebl.2018.0213.
- Derived from this study: PubMed 25873529Bredow J, Oppermann J, Hoffmann K, Hellmich M, Wenk B, Simons M, Eysel P, Zarghooni K. Clinical trial to evaluate the performance of a flexible self-adherent absorbent dressing coated with a soft silicone layer compared to a standard wound dressing after orthopedic or spinal surgery: study protocol for a randomized controlled trial. Trials. 2015 Mar 7;16:81. doi: 10.1186/s13063-015-0599-z.
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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.
Jan Bredow, physician 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 Post-Op and standard wound dressing in people with Hip-surgery and Knee-surgery, 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 11 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?
Blistering (time frame: 0-6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01988818, which also lists 2 linked publications.
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 11 May 2016.