Open AbdomenNCT01968811
Post Market Clinical Follow Up Study of Avance Foam Abdominal Dressing Kit in Open Abdomen
A study testing Avance Foam dressing kit in people with Open Abdomen, run by Molnlycke Health Care AB at 1 site in Sweden.
Trial summary
The investigation is a Post Marketing Follow-Up Study for the Avance Foam Abdominal Dressing Kit conducted as part of Mölnlycke Health Care's quality system. The primary objective is to evaluate the dressing kit as part of a negative pressure system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Abdomen
- What is being tested?
- Avance Foam dressing kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2013to Mar 2014
- 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
- Provision of written informed consent from subject or family member
- Subjects with open abdomen suitable for temporary closure with NPWT therapy
- Subjects where the viscera and/or abdominal organs need to be protected by an abdominal organ contact layer (OCL)
- Subject which (at the time of the baseline visit) are planned to be cared for between dressing changes at Intensive Care Unit
- Male or female, 18 years and above
Who cannot join
- Synthetic mesh inserted in the abdomen
- Non-enteric fistulae or unexplored fistulas
- Untreated osteomyelitis
- Malignant wounds
- Abdominal wall hernia
- Subjects previously treated with an NPWT abdominal dressing
Show all 10Show fewer
- Known allergy or hypersensitivity to any of the components in the dressing
- Pregnancy
- Subjects not suitable for the investigation according to the investigator's judgement
- Subjects included in other ongoing clinical investigation at present which could interfere with this investigation, as judged by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Centre, Post CE Mark, Open Clinical Investigation to Evaluate an Abdominal NPWT (Negative Pressure Wound Therapy) System (Avance® Pump and Avance® Foam Abdominal Dressing Kit) in Subjects With Open Abdominal Wounds
The investigation is a Post Marketing Follow-Up Study for the Avance Foam Abdominal Dressing Kit conducted as part of Mölnlycke Health Care's quality system. The primary objective is to evaluate the dressing kit as part of a negative pressure system. The secondary objectives are to collect and evaluate safety data, performance data and information on technical complications.
- Conditions
- Open Abdomen
- Being tested
- Avance Foam dressing kit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avance Foam dressing kitDevice
| Study group | Role | What they receive |
|---|---|---|
| Avance foam, abdominal dressing kit | Experimental | Not described Receives: Device: Avance Foam dressing kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate the Performance of the Dressing Kit as Part of a Negative Pressure System in Post Market Clinical Follow-up Settings
Outcome of each subject was evaluated and presented individually. Questionnaires answered by surgeon at application and removal of the kit; Baseline Overall ease of application of the kit: No. of surgeons rated as; Very easy= 4/Easy=3/Somewhat easy=2/Not easy Overall satisfaction with the kit:No. of surgeons rated as Very satisfied=3/ Satisfied=5/ Unsatisfied=2/ Very unsatisfied=0
Questionnaires were answered by surgeon at application and removal of the kit; Visit 2 Overall ease of application of the kit:No.of surgeons rated as Very easy= 2/Easy=5/Somewhat easy=0/Not easy=1 Overall satisfaction with the kit: No.of surgeons rated as Very satisfied=1/ Satisfied=3/ Unsatisfied=4/ Very unsatisfied=0 Visit 3 Overall ease of application of the kit: No.of surgeons rated as Very easy= 0/Easy=6/Somewhat easy=0/Not easy=0 Overall satisfaction. No of surgeons rated as Very satisfied=0, satisfied=4, unsatisfied=2, very unsatisfied=0
Measured: From 1 to 3 visit, depending on each subject/wound, up to 4 days.
Secondary outcomes (1)
- Fascial/Skin Closure of the Open Abdomen
The performance objective is assessed through general application and removal questions after each investigational device handling.
Measured: End of treatment, up to 4 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2014
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 Open AbdomenStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT01968811
- Sponsor's protocol ID
- Avance A01
- Status last verified
- May 2014
- First submitted
- 14 Oct 2013
- Last updated
- 11 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 Multi-Centre, Post CE Mark, Open Clinical Investigation to Evaluate an Abdominal NPWT (Negative Pressure Wound Therapy) System (Avance® Pump and Avance® Foam Abdominal Dressing Kit) in Subjects With Open Abdominal Wounds
- ClinicalTrials.gov ID
- NCT01968811
- Acronym / sponsor ID
- Avance A01
- Conditions
- Open Abdomen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Mar 2014 (actual)
- First posted
- 24 Oct 2013 (estimated)
- Results
- Posted 11 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigation is a Post Marketing Follow-Up Study for the Avance Foam Abdominal Dressing Kit conducted as part of Mölnlycke Health Care's quality system. The primary objective is to evaluate the dressing kit as part of a negative pressure system. The secondary objectives are to collect and evaluate safety data, performance data and information on technical complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avance foam, abdominal dressing kit | Experimental | Device: Avance Foam dressing kit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of written informed consent from subject or family member
- Subjects with open abdomen suitable for temporary closure with NPWT therapy
- Subjects where the viscera and/or abdominal organs need to be protected by an abdominal organ contact layer (OCL)
- Subject which (at the time of the baseline visit) are planned to be cared for between dressing changes at Intensive Care Unit
- Male or female, 18 years and above
Key exclusion criteria (10 listed)
- Synthetic mesh inserted in the abdomen
- Non-enteric fistulae or unexplored fistulas
- Untreated osteomyelitis
- Malignant wounds
- Abdominal wall hernia
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 |
|---|---|---|
| Avance Foam dressing kit | Device | Avance foam, abdominal dressing kit |
Primary outcome
To Evaluate the Performance of the Dressing Kit as Part of a Negative Pressure System in Post Market Clinical Follow-up Settings
Time frame: From 1 to 3 visit, depending on each subject/wound, up to 4 days.
Outcome of each subject was evaluated and presented individually. Questionnaires answered by surgeon at application and removal of the kit; Baseline Overall ease of application of the kit: No. of surgeons rated as; Very easy= 4/Easy=3/Somewhat easy=2/Not easy Overall satisfaction with the kit:No. of surgeons rated as Very satisfied=3/ Satisfied=5/ Unsatisfied=2/ Very unsatisfied=0 Questionnaires were answered by surgeon at application and removal of the kit; Visit 2 Overall ease of application of the kit:No.of surgeons rated as Very easy= 2/Easy=5/Somewhat easy=0/Not easy=1 Overall satisfaction with the kit: No.of surgeons rated as Very satisfied=1/ Satisfied=3/ Unsatisfied=4/ Very unsatisfied=0 Visit 3 Overall ease of application of the kit: No.of surgeons rated as Very easy= 0/Easy=6/Somewhat easy=0/Not easy=0 Overall satisfaction. No of surgeons rated as Very satisfied=0, satisfied=4, unsatisfied=2, very unsatisfied=0
1 secondary outcome
- Fascial/Skin Closure of the Open Abdomen
Time frame: End of treatment, up to 4 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avance Foam dressing kit in people with Open Abdomen, run by Molnlycke Health Care AB at 1 site 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: 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 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 11 May 2016). 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?
To Evaluate the Performance of the Dressing Kit as Part of a Negative Pressure System in Post Market Clinical Follow-up Settings (time frame: From 1 to 3 visit, depending on each subject/wound, up to 4 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 11 May 2016.