Comparative Evaluation of Two AQUACEL Ag Protocols of Care for the Management of Donor Sites - Full Text View

Purpose

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.

Condition	Intervention	Phase
Split-Thickness Donor Sites.	Device: Aquacel Ag Gelled Device: Aquacel Ag Adherent	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase IIIb, Randomized Comparative Evaluation of Two AQUACEL Ag Protocols of Care for the Management of Donor Sites.

Further study details as provided by ConvaTec Inc.:

Primary Outcome Measures:

To evaluate the proportion of subjects healed. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to healing. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Degree of pain at dressing change. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Degree of pain/discomfort while wearing the dressing at rest and during mobility. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Investigator's rating of dressing performance (per subject and overall). [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Resources utilization. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Readiness for re-harvesting. [ Time Frame: day 14 ] [ Designated as safety issue: No ]
Safety. [ Time Frame: 14 days +30 ] [ Designated as safety issue: No ]

Enrollment:	73
Study Start Date:	October 2005
Study Completion Date:	August 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Gelled Aquacel Ag gelled.	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.
Active Comparator: Adherent Aquacel Ag adherent	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.

Arms

Assigned Interventions

Active Comparator: Gelled

Aquacel Ag gelled.

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.

Active Comparator: Adherent

Aquacel Ag adherent

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731367

Locations

United States, Arizona
Maricopa Medical Center
Phoenix, Arizona, United States, 85008

Sponsors and Collaborators

ConvaTec Inc.

Bristol-Myers Squibb

Investigators

Principal Investigator:

Daniel Caruso, MD

Maricopa Medical Center

More Information

No publications provided by ConvaTec Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2009 Dec 6.

Responsible Party:	Daniel Caruso, Arizona Burn Center, Maricopa Medical Center
ClinicalTrials.gov Identifier:	NCT00731367 History of Changes
Other Study ID Numbers:	CW-0412-05-A080
Study First Received:	August 7, 2008
Last Updated:	February 2, 2009
Health Authority:	United States: Institutional Review Board Canada: Health Protection Branch

Additional relevant MeSH terms:

Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013