Clinical trial NCT03249909: Evaluation of Exufiber Ag+ and Other Gelling Fibre Dressings
Official title: A Clinical Investigation to Study the Effect of Exufiber Ag+ and Other Gelling Fibre Dressings on Wound Exudate and Bioburden in Medium to High Exuding Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wounds and Injuries
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2017-08-15
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Subjects were to be assigned in the following order:

* Eligible Subjects 1 to 50 were to be assigned to the Exufiber Ag+ cohort
* Eligible Subjects 51 to 65 were to be assigned to Exufiber
* Eligible Subjects 66 to 85 were to be assigned to Aquacel Ag Extra
* Eligible Subjects 86 to 105 were to be assigned to Exufiber Ag+ on eligible pressure ulcer subjects

The statistical analysis of the groups treated will be analysed separately with the same statistical methods.
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change in Exudate Status From Baseline to Last Visit
timeFrame: 4 weeks (28 days) or earlier if the wound is dry or healed
Secondary outcomes:
measure: 4-Week Wound Status
timeFrame: At 4 weeks (28 days)
measure: Wound Area Reduction (mm^2)
timeFrame: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed
measure: Frequency of Dressing Changes Between Visits
timeFrame: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed
measure: Tissue Type of Wound Bed
timeFrame: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed
measure: Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour
timeFrame: Total treatment period of 4 weeks (28 days)
measure: Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation
timeFrame: Total treatment period of 4 weeks (28 days)
measure: Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration
timeFrame: Total treatment period of 4 weeks (28 days)
measure: Handling and Technical Performance of the Dressing
timeFrame: At 4 weeks (28 days)
measure: Comfort, Conformability, and Acceptability of the Dressings by Subject
timeFrame: At 4 weeks (28 days) or earlier if the wound is dry or healed
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Midwestern University
state: Arizona
city: San Francisco
country: United States
facility: Center for Clinical Research, Inc.
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Boise
country: United States
facility: Boise VA Medical Center (Boise VAMC) M
state: Idaho
city: Lake Success
country: United States
facility: Northwell Health
state: New York
city: Toledo
country: United States
facility: Jobst Vascular Institue (JVI)
state: Ohio
city: Pittsburgh
country: United States
facility: Serena Group Research Institute
state: Pennsylvania
Study officials:
affiliation: University of Miami
name: Hadar Lev-Tov, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: