A Phase 2/3 interventional study of External Suction Interface and a Silicon Film in Acute and Chronic Wounds, sponsored by Molnlycke Health Care AB. Completed at 3 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-18.
Sponsored by Molnlycke Health Care AB · Phase 2/3, Interventional, and Treatment
The aim of the investigation is to evaluate the function of two new device parts to be used in a NPWT system; an on-top suction device intended to transport exudate from the wound and a silicon cover film intended to fixate the wound filler and seal tight to the skin in order to keep a moist environment.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's planned enrollment of 15 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries 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.
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Evaluate the function of a new silicon cover film and an on-top suction device to be used in a NPWT system in the treatment of acute and chronic wounds.
To evaluate the transport of exudate from the wound bed to canister and thus distribute negative pressure in the wound site
Time frame: 144 - 288 hours
To investigate the practical properties and management of the device, to evaluate the ease of use for the subject and the care giver and to assess any undesirable effects with the suction part
Time frame: 144-288 hours
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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Molnlycke Health Care AB