Trial Outcomes & Findings for Post Market Clinical Follow Up Study of Avance Foam Abdominal Dressing Kit in Open Abdomen (NCT NCT01968811)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

From 1 to 3 visit, depending on each subject/wound, up to 4 days.

Results posted on

2016-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Avance Foam, Abdominal Dressing Kit Avance Foam dressing kit
Overall Study STARTED	10
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Avance Foam, Abdominal Dressing Kit Avance Foam dressing kit
Overall Study Protocol Violation	4
Overall Study post op.ref. of subject to other hospita	1

Baseline Characteristics

Post Market Clinical Follow Up Study of Avance Foam Abdominal Dressing Kit in Open Abdomen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Avance Foam, Abdominal Dressing Kit n=10 Participants Avance Foam dressing kit
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age, Continuous	74.8 years STANDARD_DEVIATION 3.7 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment Sweden	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Avance Foam, Abdominal Dressing Kit n=10 Participants Avance Foam 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
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
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
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
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
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
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 outcome

Timeframe: End of treatment, up to 4 days.

Population: No. Analysed for efficacy ITT 10 , PP 9,

The performance objective is assessed through general application and removal questions after each investigational device handling.

Outcome measures

Outcome measures
Measure	Avance Foam, Abdominal Dressing Kit n=10 Participants Avance Foam dressing kit
- Fascial/Skin Closure of the Open Abdomen Closed fascia	5 participants
- Fascial/Skin Closure of the Open Abdomen insertion of synthetic mesh	3 participants

Adverse Events

Avance Foam, Abdominal Dressing Kit

Serious events: 5 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Avance Foam, Abdominal Dressing Kit n=10 participants at risk Avance Foam dressing kit
General disorders OCL migration	30.0% 3/10 • Number of events 3
Vascular disorders bowel ischemia	20.0% 2/10 • Number of events 2

Other adverse events

Other adverse events
Measure	Avance Foam, Abdominal Dressing Kit n=10 participants at risk Avance Foam dressing kit
Skin and subcutaneous tissue disorders blistering of skin	10.0% 1/10 • Number of events 1

Additional Information

Dr Marcus Langenskiöld

Sahlgrenska university Hospital

Phone: +46 709 433160

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place