wound healing
Conditions
Interventions
All subjects will be treated with negative-pressure wound therapy with
instillation and have their dressings changed once a week.
Safety
Wound healing
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Trauma patient who is at least 18 years old on the day the informed consent form will be signed. 2. Patient has an open wound with major skin tissue loss. 3. The wound can not be primarily closed and negative-pressure wound therapy is indicated. 4. The expected duration of treatment with negative-pressure wound therapy is at least two weeks. 5. Patient scores I to III in the American Society of Anesthesiologists physical status classification system (ASA I-III). 6. Patient provides informed consent. 7. Patient is willing and able to comply with the trial protocol.
Exclusion criteria
Exclusion criteria: 1. Open wounds with exposed blood vessels, evidence of ischemia, necrotic tissue requiring further débridement, infection or osteomyelitis. 2. Patients not treated in the RadboudUMC. 3. Pregnant women. 4. Patient has (a history of) a (chronic) pain syndrome that interferes with the interpretation of the pain score results. 5. Patient is or turns out to be allergic to one of the materials used in negative-pressure wound therapy. 6. Wounds in body surface areas that are technically difficult for applying negative-pressure wound therapy (i.e. on feet or around an external fixator). 7. Wounds with exposed organs. 8. Patient is unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy, patient safety and comfort will be evaluated by the investigator and an experienced wound consultant during dressing changes. Primarily by evaluating ingrowths of foam. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient safety and comfort will be evaluated by the investigator and an experienced wound consultant during dressing changes. Secondary by evaluating erythema of periwound skin, patients' clinical status, fluid collection beneath the dressing or other disruption of the dressing, occurrence of medical device failure and patient experience. | — |
Countries
The Netherlands
Outcome results
None listed