Evaluation of Exufiber Ag+ and Other Gelling Fibre Dressings

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-11

Study Completion Date

2019-08-19

Brief Summary

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

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Detailed Description

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Conditions

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Wounds and Injuries

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Open Label

Study Groups

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Exufiber Ag +

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.

Group Type OTHER

Exufiber Ag+

Intervention Type DEVICE

gelling fibre dressing with silver

Exufiber

Intervention Type DEVICE

gelling fibre without silver

Aquacel Ag Extra

Intervention Type DEVICE

gelling fibre with silver

Exufiber

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.

Group Type OTHER

Exufiber Ag+

Intervention Type DEVICE

gelling fibre dressing with silver

Exufiber

Intervention Type DEVICE

gelling fibre without silver

Aquacel Ag Extra

Intervention Type DEVICE

gelling fibre with silver

Aquacel® Ag Extra

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.

Group Type OTHER

Exufiber Ag+

Intervention Type DEVICE

gelling fibre dressing with silver

Exufiber

Intervention Type DEVICE

gelling fibre without silver

Aquacel Ag Extra

Intervention Type DEVICE

gelling fibre with silver

Interventions

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Exufiber Ag+

gelling fibre dressing with silver

Intervention Type DEVICE

Exufiber

gelling fibre without silver

Intervention Type DEVICE

Aquacel Ag Extra

gelling fibre with silver

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No