To proof the instillation technique prevents foam ingrowth and obstruction and investigate patient safety and comfort when reducing dressing changes in negative-pressure therapy with instillation.
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Negative pressure wound therapy is an esteemed and effective form of wound
treatment. Following current standard protocol the bandage is renewed twice per
week. This is both time-consuming and stressful for the patient and health care
professional. A new device combines negative pressure with an instillation
system reducing ingrowth and adhesion of tissue in the used foam and dressings.
Suggesting dressing changes could be reduced to once per week.
Study objective
To proof the instillation technique prevents foam ingrowth and obstruction and
investigate patient safety and comfort when reducing dressing changes in
negative-pressure therapy with instillation.
Study design
A prospective observational case series that will be performed at the Radboud
University Medical Center Nijmegen, with a sample size of n=5.
Intervention
All subjects will be treated with negative-pressure wound therapy with
instillation and have their dressings changed once a week.
Study burden and risks
Included patients could directly benefit from participation in the study;
dressing changes are time consuming and sometimes painful. Reducing the amount
of changes can be described as a benefit.
Based on our experience with the NPWT with instillation technique thus far we
do not expect any risks for patients* health or wound healing. However minor
delay in wound healing or slightly increased painful dressing changes can not
be excluded.
Based on the above, our estimation is that in our study there is a small chance
(*kleine kans*) of slight damage (*lichte schade*) and therefore a small risk
(*verwaarloosbaar risico*) according to the risk classification of the
*Nederlandse Federatie van Universitair Medische Centra* (NFU).
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59157.091.16 |