Open Abdomen
Conditions
Brief 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. The secondary objectives are to collect and evaluate safety data, performance data and information on technical complications.
Interventions
DEVICEAvance Foam dressing kit
Sponsors
Molnlycke Health Care AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provision of written informed consent from subject or family member 2. Subjects with open abdomen suitable for temporary closure with NPWT therapy 3. Subjects where the viscera and/or abdominal organs need to be protected by an abdominal organ contact layer (OCL) 4. Subject which (at the time of the baseline visit) are planned to be cared for between dressing changes at Intensive Care Unit 5. Male or female, 18 years and above
Exclusion criteria
1. Synthetic mesh inserted in the abdomen 2. Non-enteric fistulae or unexplored fistulas 3. Untreated osteomyelitis 4. Malignant wounds 5. Abdominal wall hernia 6. Subjects previously treated with an NPWT abdominal dressing 7. Known allergy or hypersensitivity to any of the components in the dressing 8. Pregnancy 9. Subjects not suitable for the investigation according to the investigator's judgement 10. Subjects included in other ongoing clinical investigation at present which could interfere with this investigation, as judged by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate the Performance of the Dressing Kit as Part of a Negative Pressure System in Post Market Clinical Follow-up Settings | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| - Fascial/Skin Closure of the Open Abdomen | End of treatment, up to 4 days. | The performance objective is assessed through general application and removal questions after each investigational device handling. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Avance Foam, Abdominal Dressing Kit Avance Foam dressing kit | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | post op.ref. of subject to other hospita | 1 |
| Overall Study | Protocol Violation | 4 |
Baseline characteristics
| Characteristic | Avance Foam, Abdominal Dressing Kit |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 74.8 years STANDARD_DEVIATION 3.7 |
| Region of Enrollment Sweden | 10 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 10 |
| serious Total, serious adverse events | 5 / 10 |
Outcome results
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
Time frame: From 1 to 3 visit, depending on each subject/wound, up to 4 days.
Population: 10 patients were enrolled and individually analysed and presented in the study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Avance Foam, Abdominal Dressing Kit | To Evaluate the Performance of the Dressing Kit as Part of a Negative Pressure System in Post Market Clinical Follow-up Settings | ease of application Very easy | 4 number of surgeons |
| Avance Foam, Abdominal Dressing Kit | To Evaluate the Performance of the Dressing Kit as Part of a Negative Pressure System in Post Market Clinical Follow-up Settings | Ease of application Easy | 3 number of surgeons |
| Avance Foam, Abdominal Dressing Kit | To Evaluate the Performance of the Dressing Kit as Part of a Negative Pressure System in Post Market Clinical Follow-up Settings | Ease of application Some what easy | 2 number of surgeons |
| Avance Foam, Abdominal Dressing Kit | To Evaluate the Performance of the Dressing Kit as Part of a Negative Pressure System in Post Market Clinical Follow-up Settings | Ease of application Not easy | 1 number of surgeons |
| Avance Foam, Abdominal Dressing Kit | To Evaluate the Performance of the Dressing Kit as Part of a Negative Pressure System in Post Market Clinical Follow-up Settings | Overall satisfaction with the kit, Very satisfied | 3 number of surgeons |
| Avance Foam, Abdominal Dressing Kit | To Evaluate the Performance of the Dressing Kit as Part of a Negative Pressure System in Post Market Clinical Follow-up Settings | Overall satisfaction with the kit, Satisfied | 5 number of surgeons |
| Avance Foam, Abdominal Dressing Kit | To Evaluate the Performance of the Dressing Kit as Part of a Negative Pressure System in Post Market Clinical Follow-up Settings | Overall satisfaction with the kit, Unsatisfied | 2 number of surgeons |
Secondary
- Fascial/Skin Closure of the Open Abdomen
The performance objective is assessed through general application and removal questions after each investigational device handling.
Time frame: End of treatment, up to 4 days.
Population: No. Analysed for efficacy ITT 10 , PP 9,
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Avance Foam, Abdominal Dressing Kit | - Fascial/Skin Closure of the Open Abdomen | Closed fascia | 5 participants |
| Avance Foam, Abdominal Dressing Kit | - Fascial/Skin Closure of the Open Abdomen | insertion of synthetic mesh | 3 participants |