Critical Illness
Conditions
Brief summary
The rational for the study is to add a thin self-adherent dressing on critically ill patients. Evaluate if the dressing might protect the skin for further breakdown.Participants will be followed for the duration of hospital stay, an expected average of 5 days.
Interventions
None listed
Sponsors
Molnlycke Health Care AB
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of written informed consent * Braden total score ≤ 12 at enrolment * Male or female, ≥ 18 at enrolment * No skin- breakdown * Subject or family member is able to understand and comply with the requirements of the study, judged by the investigator
Exclusion criteria
* Risk area dosen´t fit the dressing size * Documented skin disease * Kown allergy to any of the components in the dressing * Previous enroled in present study * Subject included in other ongoing clinical investigation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erythema (No/Yes) | During 5 days | Measure number of skin breakdown during from enrolment to termination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Experience of Use of the Dressing | During 5 days | Overall experience of use of the dressing rated on a scale from Very Poor, Poor, Good, Very Good, Excellent |
Countries
Sweden
Participant flow
Recruitment details
The recruitment period was from 17 May 2011 - 29 June 2011. The study was conducted at four intensive care units in Sweden.
Pre-assignment details
There was no wash-out or run-in phase included in the study.
Participants by arm
| Arm | Count |
|---|---|
| Window WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.
Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | discharge from the hospital | 2 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Window |
|---|---|
| Age, Continuous | 62.1 years STANDARD_DEVIATION 17.1 |
| Region of Enrollment Sweden | 24 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 24 |
| serious Total, serious adverse events | 1 / 24 |
Outcome results
Primary
Erythema (No/Yes)
Measure number of skin breakdown during from enrolment to termination.
Time frame: During 5 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Window | Erythema (No/Yes) | No | 21 participants |
| Window | Erythema (No/Yes) | Yes | 3 participants |
Secondary
Overall Experience of Use of the Dressing
Overall experience of use of the dressing rated on a scale from Very Poor, Poor, Good, Very Good, Excellent
Time frame: During 5 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Window | Overall Experience of Use of the Dressing | Very good | 9 participants |
| Window | Overall Experience of Use of the Dressing | Excellent | 1 participants |
| Window | Overall Experience of Use of the Dressing | Poor | 3 participants |
| Window | Overall Experience of Use of the Dressing | Good | 10 participants |
| Window | Overall Experience of Use of the Dressing | Very poor | 1 participants |