Assessment of pain when withdrawal of Negative Pressure Wound Therapy: Algostéril + Foam vs Foam only
Completed
- Conditions
- Patient with loss of wound exudate that needs to be treated with Negative Pressure Wound dressing.Surgery
- Registration Number
- ISRCTN16353157
- Lead Sponsor
- Brothier Laboratoires
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
1. Aged 18 years or older
2. Who have wound exudate treated with Negative Pressure Therapy for 7 days and whose treatment with Negative-Pressure Wound Therapy with black foam and without instillation needs to be continued for a minimum of 4 days
3. Able to self-assess pain
4. Can be followed during the 4 days of the study
5. Signed informed consent form
Exclusion Criteria
1. Exudate resulting from a burn
2. Under analgesic level III
3. With known diabetic neuropathy
4. Negative-Pressure Wound Therapy which is contraindicated according to Haute Autorité de Santé (HAS) recommendations
5. Participant or participating in another clinical trial within 30 days prior to inclusion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of pain using a scale from 0 to 10 at day 2 and day 4
- Secondary Outcome Measures
Name Time Method 1. Assessment of bleeding with a 5-level scale - day 2 and day 4<br>2. Quantity of exudate in the Negative Pressure Wound Dressing reservoir - day 2 and day 4<br>3. Assesment of safety - throughout the trial