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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avance foam, abdominal dressing kit | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avance Foam dressing kit | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From 1 to 3 visit, depending on each subject/wound, up to 4 days. |
| Measure | Description | Time Frame |
|---|---|---|
| - Fascial/Skin Closure of the Open Abdomen | The performance objective is assessed through general application and removal questions after each investigational device handling. | End of treatment, up to 4 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University hospital | Gothenburg | 41345 | Sweden |
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| ID | Title | Description |
|---|---|---|
| FG000 | Avance Foam, Abdominal Dressing Kit | Avance Foam dressing kit |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Avance Foam, Abdominal Dressing Kit | Avance Foam dressing kit |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | - Fascial/Skin Closure of the Open Abdomen | The performance objective is assessed through general application and removal questions after each investigational device handling. | No. Analysed for efficacy ITT 10 , PP 9, | Posted | Number | participants | End of treatment, up to 4 days. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Avance Foam, Abdominal Dressing Kit | Avance Foam dressing kit |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| OCL migration | General disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| blistering of skin | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Marcus Langenskiöld | Sahlgrenska university Hospital | +46 709 433160 | marcus.langenskiold@vgregion.se |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | 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 | 10 patients were enrolled and individually analysed and presented in the study | Posted | Number | number of surgeons | From 1 to 3 visit, depending on each subject/wound, up to 4 days. |
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| 5 |
| 10 |
| 1 |
| 10 |
| bowel ischemia | Vascular disorders |
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| Title | Measurements |
|---|---|
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| Ease of application Not easy |
|
| Overall satisfaction with the kit, Very satisfied |
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| Overall satisfaction with the kit, Satisfied |
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| Overall satisfaction with the kit, Unsatisfied |
|