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Assessment of pain when withdrawal of Negative Pressure Wound Therapy: Algostéril + Foam vs Foam only

A randomized clinical trial assessing the pain when withdrawal of Negative Pressure Wound Therapy: Algostéril + Foam vs Foam only

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16353157
Enrollment
32
Registered
2015-02-23
Start date
2014-10-07
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient with loss of wound exudate that needs to be treated with Negative Pressure Wound dressing. Surgery

Interventions

After 7 days of Negative Pressure Wound dressing, randomisation is performed in a 1:1 ratio allocation. According to the randomisation sequence, patient has to be treated with Algostéril + Foam during

Sponsors

Brothier Laboratoires
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Secondary

MeasureTime frame
1. Assessment of bleeding with a 5-level scale - day 2 and day 4 2. Quantity of exudate in the Negative Pressure Wound Dressing reservoir - day 2 and day 4 3. Assesment of safety - throughout the trial

Primary

MeasureTime frame
Assessment of pain using a scale from 0 to 10 at day 2 and day 4

Countries

France

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026