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Evaluation of Exufiber Ag + and Other Gelling Fibre Dressing

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ClinicalTrials.gov Identifier: NCT03249909
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : October 11, 2017
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
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
Estimated Primary Completion Date : December 1, 2017
Estimated Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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, Senior)
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


Contacts
Contact: Tina Kjellen +46317223000 tina.kjellen@molnlycke.com

Locations
United States, California
Center For Clinical Research Inc. Recruiting
San Francisco, California, United States, 94115
Contact: Gayana Sarkisova       gabrielle@ccr-trials.com   
Principal Investigator: Alexander Reyzelman         
Sponsors and Collaborators
Molnlycke Health Care AB

Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT03249909     History of Changes
Other Study ID Numbers: Exufiber Ag + 01
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents