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

NCT00731367 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2009-02-03

No results posted yet for this study

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.

Conditions

  • Split-Thickness Donor Sites.

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Daniel Caruso, MD · Maricopa Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2006-07-31
Completion
2006-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00731367 on ClinicalTrials.gov