Wounds and InjuriesNCT02904200
Clinical Investigation of Two Different Wound Dressings
A study testing Silicon adhesive dressing and Acrylic adhesive dressing in people with Wounds and Injuries, run by Molnlycke Health Care AB at 2 sites in Sweden.
Trial summary
The primary objective of this investigation is to evaluate changes on Peri-Wound skin from baseline to termination when using two different wound dressings The secondary objectives are to evaluate pain before, during, and after dressing removal from baseline to termination Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Silicon adhesive dressing and Acrylic adhesive dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesSweden
- Study dates
- Oct 2016to May 2017
- 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
- Traumatic, surgical or dehisced wounds, Venous Leg Ulcer, Diabetic Foot Ulcer or Pressure Ulcer indicated for treatment with NPWT therapy
- In case of multiple wounds the target wound must be ≥10 cm distant from other wounds. Selection of the target wound is according to the investigator's preference.
- Peri-wound skin assessable and 5 cm of peri-wound skin present around the wound
- Male or female, 18 years of age and above
- Signed Informed Consent
Who cannot join
- Dressing sizes does not fit the target wound
- Unexplored blind tunnels or non-enteric fistula
- Untreated osteomyelitis
- Malignant wounds
- Subjects treated with systemic immunosuppressive or glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisolon/day or equivalent.
- Wounds with necrotic tissue or eschar (if not adequately debrided)
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- Significantly bleeding wounds, as judged by the investigator
- Subject not suitable for the investigation according to the investigator's judgment
- Subject included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator
- Known allergy/hypersensitivity to any of the components included into the investigation.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomized Open, Controlled Pilot Investigation Comparing Trauma to the Periwound Skin and Pain During Treatment With Avance NPWT System When Using Two Different Fixations
The primary objective of this investigation is to evaluate changes on Peri-Wound skin from baseline to termination when using two different wound dressings
The secondary objectives are to evaluate pain before, during, and after dressing removal from baseline to termination
Read the detailed description
A prospective randomized clinical investigation will be conducted at two sites in Sweden.
Male or female, 18 years or older with following wound types:
- traumatic, surgical or dehisced wounds,
- venous leg ulcer or pressure ulcer will be included into the clinical investigation. 32 evaluated subjects (i:e 16 subjects per arm) will be followed during maximum three weeks. The treatment arm (either silicon adhesive dressing or acrylic adhesive dressing). Patients will be randomized using optimal allocation (minimization) balancing for the following baseline variables type of skin (normal/dry/flaky/oily/moist) and age. Eligible patients will be randomized to receive either silicon adhesive dressing or acrylic adhesive dressing in a ratio of 1:1 provided.
- Conditions
- Wounds and Injuries
- Being tested
- Silicon adhesive dressing, Acrylic adhesive dressing
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicon adhesive dressingDevice
Sterile soft silicon adhesive dressing
Acrylic adhesive dressingDevice
Sterile acrylic adhesive dressing
| Study group | Role | What they receive |
|---|---|---|
| Silicon adhesive dressing | Experimental | Sterile soft silicon adhesive dressing Receives: Device: Silicon adhesive dressing |
| Acrylic adhesive dressing | Active comparator | Sterile acrylic adhesive dressing Receives: Device: Acrylic adhesive dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on Peri-Wound Skin
The primary objective of this investigation is to evaluate changes on Peri-Wound skin from baseline to termination when using two different wound dressings. The primary endpoint could not be calculated as intended because the baseline score was not evaluable due to missing values for the one subject that completed follow up. The primary outcome is therefore presented at 12 days. The total of the five scores provide a range from 0 to 15, with higher scores indicating a worse outcome.
The primary endpoint was assessed through the change in the sum of Peri-Wound Skin outcome scores (0-15) collected at each visit (Visit 1 (baseline), Visit 2 (day 4), Visit 3 (day 7), Visit 4 last visit (day 12)) from baseline to termination. The sum of scores will be obtained from five separate data scores, Redness/Irritation, Flaky, Maceration, Blistering, Skin tears, which will be scored separately with a value between 0 and 3 (None=0, Mild=1, Moderate=2, Severe=3).
Measured: Visit 4 last visit (day 12)
Secondary outcomes (1)
VAS Scale (0-100mm)
Pain level before, during and after dressing removal. A visual analog scale (VAS) was used by the subjects to assess pain, with a range from 0 to 100, where 100 indicates the worst possible pain.
Measured: 0-12 days. Visit 1 (baseline), Visit 2 (day 4), Visit 3 (day 7), Visit 4 last visit (day 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2017
- Study completionMay 2017
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 Wounds and InjuriesStudies 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marianne Bergstrom, Principal investigator, Sundsvalls Sjukhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904200
- Sponsor's protocol ID
- Avance 02
- Status last verified
- Sep 2020
- First submitted
- 13 Sep 2016
- Last updated
- 1 Apr 2021
- 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 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open, Controlled Pilot Investigation Comparing Trauma to the Periwound Skin and Pain During Treatment With Avance NPWT System When Using Two Different Fixations
- ClinicalTrials.gov ID
- NCT02904200
- Acronym / sponsor ID
- Avance 02
- Conditions
- Wounds and Injuries
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Posted 1 Apr 2021
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 changes on Peri-Wound skin from baseline to termination when using two different wound dressings
The secondary objectives are to evaluate pain before, during, and after dressing removal from baseline to termination
Detailed description
A prospective randomized clinical investigation will be conducted at two sites in Sweden.
Male or female, 18 years or older with following wound types:
- traumatic, surgical or dehisced wounds,
- venous leg ulcer or pressure ulcer will be included into the clinical investigation. 32 evaluated subjects (i:e 16 subjects per arm) will be followed during maximum three weeks. The treatment arm (either silicon adhesive dressing or acrylic adhesive dressing). Patients will be randomized using optimal allocation (minimization) balancing for the following baseline variables type of skin (normal/dry/flaky/oily/moist) and age. Eligible patients will be randomized to receive either silicon adhesive dressing or acrylic adhesive dressing 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 |
|---|---|---|
| Silicon adhesive dressing | Experimental | Device: Silicon adhesive dressingSterile soft silicon adhesive dressing |
| Acrylic adhesive dressing | Active comparator | Device: Acrylic adhesive dressingSterile acrylic adhesive 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)
- Traumatic, surgical or dehisced wounds, Venous Leg Ulcer, Diabetic Foot Ulcer or Pressure Ulcer indicated for treatment with NPWT therapy
- In case of multiple wounds the target wound must be ≥10 cm distant from other wounds. Selection of the target wound is according to the investigator's preference.
- Peri-wound skin assessable and 5 cm of peri-wound skin present around the wound
- Male or female, 18 years of age and above
- Signed Informed Consent
Key exclusion criteria (10 listed)
- Dressing sizes does not fit the target wound
- Unexplored blind tunnels or non-enteric fistula
- Untreated osteomyelitis
- Malignant wounds
- Subjects treated with systemic immunosuppressive or glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisolon/day or equivalent.
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 |
|---|---|---|
| Silicon adhesive dressingSterile soft silicon adhesive dressing | Device | Silicon adhesive dressing |
| Acrylic adhesive dressingSterile acrylic adhesive dressing | Device | Acrylic adhesive dressing |
Primary outcome
Changes on Peri-Wound Skin
Time frame: Visit 4 last visit (day 12)
The primary objective of this investigation is to evaluate changes on Peri-Wound skin from baseline to termination when using two different wound dressings. The primary endpoint could not be calculated as intended because the baseline score was not evaluable due to missing values for the one subject that completed follow up. The primary outcome is therefore presented at 12 days. The total of the five scores provide a range from 0 to 15, with higher scores indicating a worse outcome. The primary endpoint was assessed through the change in the sum of Peri-Wound Skin outcome scores (0-15) collected at each visit (Visit 1 (baseline), Visit 2 (day 4), Visit 3 (day 7), Visit 4 last visit (day 12)) from baseline to termination. The sum of scores will be obtained from five separate data scores, Redness/Irritation, Flaky, Maceration, Blistering, Skin tears, which will be scored separately with a value between 0 and 3 (None=0, Mild=1, Moderate=2, Severe=3).
1 secondary outcome
VAS Scale (0-100mm)
Time frame: 0-12 days. Visit 1 (baseline), Visit 2 (day 4), Visit 3 (day 7), Visit 4 last visit (day 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- 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.
Marianne Bergstrom principal investigator
Sundsvalls Sjukhus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silicon adhesive dressing and Acrylic adhesive dressing in people with Wounds and Injuries, run by Molnlycke Health Care AB at 2 sites in Sweden.
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 10 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: stopped early, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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 Apr 2021). 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?
Changes on Peri-Wound Skin (time frame: Visit 4 last visit (day 12)). 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 Apr 2021.