Evaluation of Exufiber Ag+ and Other Gelling Fibre Dressings

Molnlycke Health Care

Status: Completed

Conditions: Wounds and Injuries

Treatments: Device: Aquacel Ag Extra; Device: Exufiber; Device: Exufiber Ag+

Study type: Interventional

Funder types: Industry

Identifiers

NCT03249909

Exufiber Ag+ 01

Details and patient eligibility

About

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

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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109 participants in 3 patient groups

Exufiber Ag +

Other group

Description:

Gelling fibre dressing with silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis.

Treatment:

Device: Exufiber Ag+

Device: Aquacel Ag Extra

Device: Exufiber

Exufiber

Other group

Description:

Gelling fibre dressing without silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis.

Treatment:

Device: Exufiber Ag+

Device: Aquacel Ag Extra

Device: Exufiber

Aquacel® Ag Extra

Other group

Description:

Gelling fibre dressing with silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis.

Treatment:

Device: Exufiber Ag+

Device: Aquacel Ag Extra

Device: Exufiber