None listed
Conditions
Brief summary
The research project is studying a new type of dressing for wound to the lower leg, that requires a skin graft. The new dressing is called a PICO dressing. We aim to show that PICO dressing is as efficient as the standard dressing in terms of graft take rate, while giving participants a better quallity of life during healing and a reduced lenght of hospital stay.
Interventions
Negative-pressure wound therapy system called PICO.
PICO is a small portable device that is used to treat wounds. The PICO is carried by the patient in a back pants pocket or wherever it is the most confortable for them.
The device is left switched on for 7 consecutive days. There are no dressing changes during that period.
The PICO devive can be disconnected from the dressing for showering.
The PICO pump maintains negative pressure wound therapy at 80 mmHg (nominal) +/- 20 mmHg to the wound
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Negative-pressure wound therapy system called PICO. PICO is a small portable device that is used to treat wounds. The PICO is carried by the patient in a back pants pocket or wherever it is the most confortable for them. The device is left switched on for 7 consecutive days. There are no dressing changes during that period. The PICO devive can be disconnected from the dressing for showering. The PICO pump maintains negative pressure wound therapy at 80 mmHg (nominal) +/- 20 mmHg to the wound surface.
Sponsors
Peninsula Health
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1/ Male or female more than 18 years of age 2/ Presents with a lower leg lesion or wound requiring split thickness skin graft
Exclusion criteria
Has malignancy in the wound bed or margins of the wound (except in palliative care to enhance quality of life). Has previously confirmed and untreated osteomyelitis. Has non-enteric and unexplored fistulas. Has necrotic tissue with eschar present. Has exposed arteries, veins, nerves, bones, tendon or organs. Has anastomotic sites. Has emergency airway aspiration. Has pleural, mediastinal or chest tube drainage. Has surgical suction. Has a wound that is currently clinically infected, i.e. cellulitic or malodorous discharge. Has a wound greater than 15 x 20 cm or more than 2cm deep. Is not able to bear weight or mobilise due to underlying fractures or other injuries or illnesses.
Outcome results
None listed