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Clinical Utility of a New Silver Gel for Use on Chronic Wounds

Primary Purpose

Chronic Wounds

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Normlgel Ag

About this trial

This is an interventional treatment trial for Chronic Wounds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed informed consent
Both genders with an age >18 years
Subjects with chronic wounds < 1 year chronicity that are assessed as having localized infection or inflammation (i.e. not felt to have systemic involvement) as indicated by the presence of at least 2 of the following clinical signs of infection:
- Erythema
- Edema
- Warmth
- Increased drainage
- Foul odor
Subject's wounds may also present with:
- presence of eschar or slough that needs to be treated prior to normal standard of care OR
- A need for topical care after debridement
Study site to include only ONE wound to be treated

Exclusion Criteria:

Presence of fever with 2 or more clinical signs of infection that in the opinion of the investigator is indicative of a more systemic type infection.
Use of anti-microbial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days
Wound > 1 year old
Wound > 10 cm x 10 cm (l x w)
Wound > 6 cm deep
Use of chemical/enzymatic and biological debridement within 7 days of investigation start
Necrotizing wounds
Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment.
Subjects with poorly controlled diabetes mellitus (as judged by the investigator).
Subjects treated with systemic glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisone/day or equivalent.
Known allergy/hypersensitivity to any of the components of the investigation products.
Subjects with physical and/or mental conditions that are not expected to comply with the investigation, including subjects totally confined to bed.
Participation in other clinical investigation(s) within 1 month prior to Previously randomized to this investigation

Sites / Locations

Joseph M. Still Research Foundation, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device, dressing

Arm Description

Normlgel Ag is an opaque, amorphous hydrogel containing a high water content, water soluble polymer chains and an antimicrobial silver compound.

Outcomes

Primary Outcome Measures

Resolution of Signs and Symptoms of Local Wound Infection/Inflammation.

Signs and symptoms of local wound infection/inflammation will be assessed by visual infection assessment (including body temperature) and wound status.

Secondary Outcome Measures

Infection Assessment

Erythema, edema, warmth, increased drainage, foul odor and fever will be assessed at each visit.

Pain Upon Application of Investigational Product.

VAS pain scale will be used to measuring pain at each dressing change.

Full Information

NCT ID

NCT01442103

First Posted

September 13, 2011

Last Updated

March 15, 2016

Sponsor

Molnlycke Health Care AB

1. Study Identification

Unique Protocol Identification Number

NCT01442103

Brief Title

Clinical Utility of a New Silver Gel for Use on Chronic Wounds

Official Title

Open, Non Comparative, Single Center Investigation Exploring the Clinical Utility of a New Silver Gel for Use on Chronic Wounds

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Molnlycke Health Care AB

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This investigation will be conducted in the US as a single-center study to evaluate in total 10 subjects, to explore the clinical utility of a new silver gel for use on chronic wounds.

Detailed Description

Both inpatients and outpatients will be included in this study. The patients will present with chronic wounds in need of initial treatment prior to initiating standard of care (i.e. wound bed with eschar or slough), in need of treatment after debridement or with presenting inflammation along with need for treatment.Only one wound will be chosen for treatment in the study and the area should not exceed 10x10 cm and not be deeper than 6 cm. Photos of the wound will be taken at each visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Wounds

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Device, dressing

Arm Type

Experimental

Arm Description

Normlgel Ag is an opaque, amorphous hydrogel containing a high water content, water soluble polymer chains and an antimicrobial silver compound.

Intervention Type

Device

Intervention Name(s)

Normlgel Ag

Intervention Description

Normlgel Ag dressing will be changed together with planned investigation visits. Dressing changes between visits will be performed at home on Day 3 or 4 of each week by subject or caregiver and documented in a dressing log.

Primary Outcome Measure Information:

Title

Resolution of Signs and Symptoms of Local Wound Infection/Inflammation.

Description

Signs and symptoms of local wound infection/inflammation will be assessed by visual infection assessment (including body temperature) and wound status.

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Infection Assessment

Description

Erythema, edema, warmth, increased drainage, foul odor and fever will be assessed at each visit.

Time Frame

4 weekks

Title

Pain Upon Application of Investigational Product.

Description

VAS pain scale will be used to measuring pain at each dressing change.

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed consent Both genders with an age >18 years Subjects with chronic wounds < 1 year chronicity that are assessed as having localized infection or inflammation (i.e. not felt to have systemic involvement) as indicated by the presence of at least 2 of the following clinical signs of infection: Erythema Edema Warmth Increased drainage Foul odor Subject's wounds may also present with: presence of eschar or slough that needs to be treated prior to normal standard of care OR A need for topical care after debridement Study site to include only ONE wound to be treated Exclusion Criteria: Presence of fever with 2 or more clinical signs of infection that in the opinion of the investigator is indicative of a more systemic type infection. Use of anti-microbial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days Wound > 1 year old Wound > 10 cm x 10 cm (l x w) Wound > 6 cm deep Use of chemical/enzymatic and biological debridement within 7 days of investigation start Necrotizing wounds Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment. Subjects with poorly controlled diabetes mellitus (as judged by the investigator). Subjects treated with systemic glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisone/day or equivalent. Known allergy/hypersensitivity to any of the components of the investigation products. Subjects with physical and/or mental conditions that are not expected to comply with the investigation, including subjects totally confined to bed. Participation in other clinical investigation(s) within 1 month prior to Previously randomized to this investigation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zaheed Hassan, MD

Organizational Affiliation

Josepth M. Still Research Foundation, Augusta, Georgia, US

Official's Role

Principal Investigator

Facility Information:

Facility Name

Joseph M. Still Research Foundation, Inc.

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30909

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Utility of a New Silver Gel for Use on Chronic Wounds

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