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Clinical Trials/ISRCTN16353157
ISRCTN16353157
Completed
Not Applicable

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

Brothier Laboratoires0 sites32 target enrollmentFebruary 23, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patient with loss of wound exudate that needs to be treated with Negative Pressure Wound dressing.
Sponsor
Brothier Laboratoires
Enrollment
32
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 23, 2015
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Brothier Laboratoires

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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