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Evaluation of Exufiber Ag + and Other Gelling Fibre Dressing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03249909
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB

Brief Summary:
Investigate impact of gelling fiber dressings on handling exudate in medium to high exuding wounds

Condition or disease Intervention/treatment Phase
Wounds and Injuries Device: Exufiber Ag + Device: Exufiber Device: Aquacel Ag Extra Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

The first eligible 50 subjects will be assigned by the investigator to Exufiber Ag+, Subjects 51 to 65 will be assigned to Exufiber, Subjects 66 to 85 will be assigned to Aquacel Ag Extra.

The statistical analysis of the groups treated with Exufiber Ag +, Exufiber or Aquacel Ag Extra will be analysed separately with the same statistical methods.

Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Investigation to Study the Effect of Exufiber Ag+ and Other Gelling Fibre Dressings on Wound Exudate in Medium to High Exuding Wound
Actual Study Start Date : August 14, 2017
Actual Primary Completion Date : August 19, 2019
Actual Study Completion Date : August 19, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dressings Device: Exufiber Ag +
Gelling Fiber Dressing with Ag

Device: Exufiber
Gelling Fiber Dressing without Ag

Device: Aquacel Ag Extra
Gelling Fiber Dressing with Ag




Primary Outcome Measures :
  1. Reduction in exudate from baseline to last visit [ Time Frame: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed ]
    Dressing condition (Dry/Moist/Wet/Saturated/Leaking)


Secondary Outcome Measures :
  1. Status of the wound and peri-wound skin from baseline to last visit [ Time Frame: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed ]
    Evaluated by the Nurse/Investigator Exudate nature (Serous/Serosanguinous/Sanguinous/Purulent/NA)

  2. Status of the wound and peri-wound skin from baseline to last visit [ Time Frame: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed ]
    Evaluated by the Nurse/Investigator Malodour (None, Slight, Moderate, Strong)

  3. Status of the wound and peri-wound skin from baseline to last visit [ Time Frame: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed ]
    Evaluated by the Nurse/Investigator Redness/Irritation under the Primary dressing (Y/N)

  4. Status of the wound and peri-wound skin from baseline to last visit [ Time Frame: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed ]
    Evaluated by the Nurse/Investigator Redness/irritation outside the Primary dressing (Y/N)

  5. Status of the wound and peri-wound skin from baseline to last visit [ Time Frame: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed ]
    Evaluated by the Nurse/Investigator Maceration under the Primary dressing (Y/N)

  6. To evaluate comfort, conformability and acceptability of the dressing [ Time Frame: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed ]
    Evaluated by the subject Comfort when wearing the primary dressing (Very Poor/Poor/Good/Very Good/NA)

  7. To evaluate comfort, conformability and acceptability of the dressing [ Time Frame: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed ]
    Evaluated by the subject Ease of mobility while wearing the primary dressing (Very Poor/Poor/Good/Very Good/NA)

  8. To evaluate comfort, conformability and acceptability of the dressing [ Time Frame: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed ]
    Evaluated by the subject Primary dressing remained in place (Very Poor/Poor/Good/Very Good/NA)

  9. To evaluate comfort, conformability and acceptability of the dressing [ Time Frame: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed ]
    Evaluated by the subject Stinging or burning while wearing the primary dressing (Y/N/NA)

  10. To evaluate comfort, conformability and acceptability of the dressing [ Time Frame: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed ]
    Evaluated by the subject Primary dressing, overall experience (Very Poor/Poor/Good/Very Good/NA)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed Informed Consent Form
  • Both gender ≥ 18 years old
  • From Medium to High exuding wound

Exclusion Criteria:

  • Known allergy or hypersensitivity to any of the treatment dressings
  • Pregnant or lactating females
  • Subjects with a target wound that is ≤1 cm2
  • Subjects with a target wound that is a full thickness burn
  • Subjects with a target wound that is a full thickness pressure ulcer
  • Subjects with known immunodeficiency
  • Subject taking systemic antibiotics for wound infection
  • Subject were the target wound is located on an infected limb interfered by minimal blood flow in the opinion of the investigator
  • Subject with a target wound with unexplored enteric fistula
  • Subjects who in the opinion of the investigator, will have problems following the protocol
  • Subjects needing treatment with oxidizing agents such as hypochlorite solutions or hydrogen peroxide
  • Previously enrolled in the present investigation
  • Inclusion in other ongoing investigations at present that would preclude the subject from participating in this investigation as judged by the investigator
  • Involvement in the planning and conduct of the clinical investigation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249909


Locations
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United States, Arizona
Midwestern University
Glendale, Arizona, United States, 85308
United States, California
Center For Clinical Research Inc.
San Francisco, California, United States, 94115
United States, Florida
University of Miami
Miami, Florida, United States, 33125
Florida Health Science Center, Inc
Tampa, Florida, United States, 33606
United States, Idaho
Boise VA Medical Center (Boise VAMC) M
Boise, Idaho, United States, 83702
United States, New York
Feinstein Institute for Medical Research
Lake Success, New York, United States, 11042
United States, Ohio
Jobst Vascular Institue (JVI)
Toledo, Ohio, United States, 43606
United States, Pennsylvania
SerenaGroup Research Institute
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Molnlycke Health Care AB
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Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT03249909    
Other Study ID Numbers: Exufiber Ag + 01
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Wounds and Injuries
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents