Trial Outcomes & Findings for Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia (NCT NCT01966380)

Results Overview

Absorption capacity measured subjectively: NA/POOR/GOOD/VERY GOOD/EXCELLENT

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

2-3 weeks

Results posted on

2015-12-23

Participant milestones
Measure	Cross-over Assignment Leia First intervention Leia, 5 Days, then second intervention Hydroactive surgical dressing 5 Days.	Cross-over Assignment Hydroactive Surgical Dressing First intervention Hydroactive surgical dressing 5 Days, then second intervention Leia, 5 Days..
Overall Study STARTED	3	3
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	0	1

Withdrawal data not reported

Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia

Baseline characteristics by cohort
Measure	Leia and Hydroactive Surgical Dressing n=6 Participants In the case of this study, participants served as their own control.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants
Age, Categorical >=65 years	5 Participants n=93 Participants
Age, Continuous	71 years n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	4 Participants n=93 Participants
Region of Enrollment Sweden	6 participants n=93 Participants

Timeframe: 2-3 weeks

Population: Participants served as their own controll, those the total amount of participants is reflekted in both of the outcome measurements.

Absorption capacity measured subjectively: NA/POOR/GOOD/VERY GOOD/EXCELLENT

Outcome measures
Measure	Leia n=20 Abosorbtion capacity of wounddressing Intervention: Device, Leia dressing Cross-over design, the patient was his own controll. 6 patients were treated in total.	Hydroactivate Surgical Dressing n=21 Abosorbtion capacity of wounddressing Intervention: Device, Hydroactivate surgical dressing. Cross-over design, the patient was his own controll. 6 patients were treated in total.
Absorption of Wound Exudates. Good	8 Total no. assess. in each wounddressing	7 Total no. assess. in each wounddressing
Absorption of Wound Exudates. Very good	5 Total no. assess. in each wounddressing	5 Total no. assess. in each wounddressing
Absorption of Wound Exudates. Excellent	0 Total no. assess. in each wounddressing	1 Total no. assess. in each wounddressing
Absorption of Wound Exudates. NA	7 Total no. assess. in each wounddressing	8 Total no. assess. in each wounddressing
Absorption of Wound Exudates. Poor	0 Total no. assess. in each wounddressing	0 Total no. assess. in each wounddressing

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Leia n=6 participants at risk Intervention: Device, Leia dressing Cross-over design, the patient was his own controll. 6 patients were treated in total.	Hydroactive Surgical Dressing n=6 participants at risk Intervention: Device: Hydroactive surgical dressing Cross-over design, the patient was his own controll. 6 patients were treated in total.
Skin and subcutaneous tissue disorders additional wound	50.0% 3/6	0.00% 0/6

Sahlgrenska university hospital

Phone: 031-3421000

Restriction type: OTHER