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Trial record 2 of 375 for:    Protocol AG

Comparative Evaluation of Two AQUACEL Ag Protocols of Care for the Management of Donor Sites

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00731367
Recruitment Status : Completed
First Posted : August 11, 2008
Last Update Posted : February 3, 2009
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
ConvaTec Inc.

Tracking Information
First Submitted Date  ICMJE August 7, 2008
First Posted Date  ICMJE August 11, 2008
Last Update Posted Date February 3, 2009
Study Start Date  ICMJE October 2005
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2008)
To evaluate the proportion of subjects healed. [ Time Frame: 14 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2008)
  • Time to healing. [ Time Frame: 14 days ]
  • Degree of pain at dressing change. [ Time Frame: 14 days ]
  • Degree of pain/discomfort while wearing the dressing at rest and during mobility. [ Time Frame: 14 days ]
  • Investigator's rating of dressing performance (per subject and overall). [ Time Frame: 14 days ]
  • Resources utilization. [ Time Frame: 14 days ]
  • Readiness for re-harvesting. [ Time Frame: day 14 ]
  • Safety. [ Time Frame: 14 days +30 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Evaluation of Two AQUACEL Ag Protocols of Care for the Management of Donor Sites
Official Title  ICMJE A Phase IIIb, Randomized Comparative Evaluation of Two AQUACEL Ag Protocols of Care for the Management of Donor Sites.
Brief Summary

This phase IIIb, randomized, comparative, multi-center study is designed to evaluate two AQUACEL Ag protocols of care for the management of split-thickness donor sites. Both protocols of care will utilize AQUACEL Ag as the primary dressing. As per the randomization assignment, one protocol of care will have the AQUACEL Ag initially covered with a gauze dressing to create an adherent state and in the other protocol of care the AQUACEL Ag will be covered with a transparent film to maintain a gelled state.

The primary objective of the study will be to quantify the proportion of subjects healed at 14 days. Secondary objectives will include: time to healing, degree of pain at dressing change and while wearing the dressing, simplicity of use, resources used in treatment and safety. Approximately 68 subjects will be enrolled from 10 centers from within the US and Canada.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Split-Thickness Donor Sites.
Intervention  ICMJE
  • Device: Aquacel Ag Gelled
    AQUACEL Ag is produced by changing a small fraction of the sodium ions present in AQUACEL for silver ions and then stabilizing the complex formed by adding chloride. This produces a characteristic silver gray product. There are no counter ions (such as nitrate or sulphadiazine ions) present: these compounds, found in many silver containing products, are known to retard wound healing. AQUACEL Ag maintains a moist wound-healing environment while, at the same time, killing wound pathogens that are immobilized within the dressing. It also reduces bioburden at the wound-dressing surface, thus minimizing the risk of wound infection and facilitating wound healing.
  • Device: Aquacel Ag Adherent
    AQUACEL Ag is produced by changing a small fraction of the sodium ions present in AQUACEL for silver ions and then stabilizing the complex formed by adding chloride. This produces a characteristic silver gray product. There are no counter ions (such as nitrate or sulphadiazine ions) present: these compounds, found in many silver containing products, are known to retard wound healing. AQUACEL Ag maintains a moist wound-healing environment while, at the same time, killing wound pathogens that are immobilized within the dressing. It also reduces bioburden at the wound-dressing surface, thus minimizing the risk of wound infection and facilitating wound healing.
Study Arms  ICMJE
  • Active Comparator: Gelled
    Aquacel Ag gelled.
    Intervention: Device: Aquacel Ag Gelled
  • Active Comparator: Adherent
    Aquacel Ag adherent
    Intervention: Device: Aquacel Ag Adherent
Publications * Blome-Eberwein S, Johnson RM, Miller SF, Caruso DM, Jordan MH, Milner S, Tredget EE, Sittig KM, Smith L. Hydrofiber dressing with silver for the management of split-thickness donor sites: a randomized evaluation of two protocols of care. Burns. 2010 Aug;36(5):665-72. doi: 10.1016/j.burns.2009.06.193. Epub 2009 Dec 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2008)
73
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2006
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject or legally authorized representative must provide written informed consent.
  • Subject who is younger than legal consenting age must have a legally authorized representative who will provide written informed consent.
  • The subject is scheduled to undergo a split-thickness skin graft (autograft)
  • Harvesting of the donor site must be limited to the location and size of the anterior thigh
  • The selected anterior thigh must be a first - time harvesting.

Exclusion Criteria:

  • Subjects with known skin sensitivity to any of the dressing components.
  • Subjects who require a full thickness graft.
  • The subject with a poor prognosis, which would make it unlikely that he/she would survive the 21 day study period.
  • Subjects who have been previously randomized into the study, or who are presently participating in another clinical trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00731367
Other Study ID Numbers  ICMJE CW-0412-05-A080
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel Caruso, Arizona Burn Center, Maricopa Medical Center
Study Sponsor  ICMJE ConvaTec Inc.
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Principal Investigator: Daniel Caruso, MD Maricopa Medical Center
PRS Account ConvaTec Inc.
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP