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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB
ClinicalTrials.gov Identifier:
NCT01442103
First received: September 13, 2011
Last updated: October 16, 2013
Last verified: November 2012
Results First Received: July 1, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Wounds
Intervention: Device: Normlgel Ag

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period was from 15 September 2011 – 01 May 2012. The study was conducted at the Advanced Burn and Wound Clinic at the Joseph M. Still Burn Center in Augusta, Georgia.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

PreAssignment details:

There was not wash-out or run-in phase included in the study. Subjects were expected to have at least 2 signs of local irritation or inflammation but no active or systemic infection at the time of consent.


Reporting Groups
  Description
Silver Gel, Chronic Wounds 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.

Participant Flow:   Overall Study
    Silver Gel, Chronic Wounds  
STARTED     10  
COMPLETED     8  
NOT COMPLETED     2  
Lost to Follow-up                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Silver Gel, Chronic Wounds Open, non-comparative, single-centre investigation exploring the clinical utility of a new silver gel for use on chronic wounds.

Baseline Measures
    Silver Gel, Chronic Wounds  
Number of Participants  
[units: participants]
  10  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     7  
>=65 years     3  
Age  
[units: years]
Mean ± Standard Deviation
  58.7  ± 18.7  
Gender  
[units: participants]
 
Female     5  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     10  



  Outcome Measures

1.  Primary:   Resolution of Signs and Symptoms of Local Wound Infection/Inflammation.   [ Time Frame: 4 weeks ]

2.  Secondary:   Infection Assessment   [ Time Frame: 4 weekks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Pain Upon Application of Investigational Product.   [ Time Frame: 4 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small study population, 2 patients lost to follow-up.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Joan wilson
Organization: Molnlycke Health Care
phone: +1 706-650-1012
e-mail: joan.wilson@molnlycke.com


No publications provided


Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01442103     History of Changes
Other Study ID Numbers: Ngel Ag 01
Study First Received: September 13, 2011
Results First Received: July 1, 2013
Last Updated: October 16, 2013
Health Authority: United States: Institutional Review Board