An observational study in Critical Illness, sponsored by Molnlycke Health Care AB. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-09.
Sponsored by Molnlycke Health Care AB · Observational
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.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 24 is below the median of 130 across 867 observational studies indexed under Critical Illness.
Browse Critical Illness studies →Molnlycke Health Care AB is the lead sponsor of 58 studies on the registry; 7 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Critically ill patients at ICU.
Exclusion Criteria:
Erythema (No/Yes)
Measure number of skin breakdown during from enrolment to termination.
Time frame: During 5 days
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
The recruitment period was from 17 May 2011 - 29 June 2011. The study was conducted at four intensive care units in Sweden.
| Milestone | Window |
|---|---|
| Started | 24 |
| Completed | 21 |
| Not completed | 3 |
| Withdrew: Discharge from the hospital | 2 |
| Withdrew: Protocol violation | 1 |
Measure number of skin breakdown during from enrolment to termination.
| participants | Window |
|---|---|
| No | 21 |
| Yes | 3 |
Overall experience of use of the dressing rated on a scale from Very Poor, Poor, Good, Very Good, Excellent
| participants | Window |
|---|---|
| Very poor | 1 |
| Poor | 3 |
| Good | 10 |
| Very good | 9 |
| Excellent | 1 |
Collected over Adverse Event were collected from enrollment to termination ( 5 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Window | — | 1/24 (4.2%) | 7/24 (29.2%) |
| Event | Window |
|---|---|
| DeathVascular disorders | 1/24 |
| Event | Window |
|---|---|
| Pressure UlcerSkin and subcutaneous tissue disorders | 4/24 |
| Brady cardiaCardiac disorders | 1/24 |
| PneumoniRespiratory, thoracic and mediastinal disorders | 1/24 |
| Tachy CardiaCardiac disorders | 1/24 |
| Arterial FlutterCardiac disorders | 1/24 |
| Thromboflebitis in right armInfections and infestations | 1/24 |
| BronchospasmRespiratory, thoracic and mediastinal disorders | 1/24 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/24 |
| Age, Continuous(years) | Window |
|---|---|
| Mean | 62.1 ± 17.1 |
| Sex: Female, Male(Participants) | Window |
|---|---|
| Female | 9 |
| Male | 15 |
| Region of Enrollment(participants) | Window |
|---|---|
| Sweden | 24 |
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Molnlycke Health Care AB