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Completed

NCT Number: NCT00731367

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

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.

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Key information

Conditions

Split-Thickness Donor Sites.

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Maricopa Medical Center

Phoenix, Arizona, 85008, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aquacel Ag Gelled

Device

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.

Aquacel Ag Adherent

Device

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.

Primary outcomes

  1. To evaluate the proportion of subjects healed.

    Time frame: 14 days

Secondary outcomes

  1. Time to healing.

    Time frame: 14 days

  2. Degree of pain at dressing change.

    Time frame: 14 days

  3. Degree of pain/discomfort while wearing the dressing at rest and during mobility.

    Time frame: 14 days

  4. Investigator's rating of dressing performance (per subject and overall).

    Time frame: 14 days

  5. Resources utilization.

    Time frame: 14 days

  6. Readiness for re-harvesting.

    Time frame: day 14

  7. Safety.

    Time frame: 14 days +30

Sponsors and collaborators

Lead sponsor

ConvaTec Inc.

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

A Phase IIIb, Randomized Comparative Evaluation of Two AQUACEL Ag Protocols of Care for the Management of Donor Sites.

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Aug 11, 2008
Registry last updated
Feb 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.