Split-Thickness Donor Sites.Phase 3NCT00731367
Comparative Evaluation of Two AQUACEL Ag Protocols of Care for the Management of Donor Sites
A Phase 3 study testing Aquacel Ag Gelled and Aquacel Ag Adherent in people with Split-Thickness Donor Sites., run by ConvaTec Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Split-Thickness Donor Sites.
- What is being tested?
- Aquacel Ag Gelled and Aquacel Ag Adherent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Aug 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIIb, Randomized 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.
- Conditions
- Split-Thickness Donor Sites.
- Being tested
- Aquacel Ag Gelled, Aquacel Ag Adherent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquacel Ag GelledDevice
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 AdherentDevice
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 group | Role | What they receive |
|---|---|---|
| Gelled | Active comparator | Aquacel Ag gelled. Receives: Device: Aquacel Ag Gelled |
| Adherent | Active comparator | Aquacel Ag adherent Receives: Device: Aquacel Ag Adherent |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the proportion of subjects healed.
Measured: 14 days
Secondary outcomes (7)
Time to healing.
Measured: 14 days
Degree of pain at dressing change.
Measured: 14 days
Degree of pain/discomfort while wearing the dressing at rest and during mobility.
Measured: 14 days
Investigator's rating of dressing performance (per subject and overall).
Measured: 14 days
Resources utilization.
Measured: 14 days
Readiness for re-harvesting.
Measured: day 14
Safety.
Measured: 14 days +30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startOct 2005
- Primary completionJul 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Split-Thickness Donor Sites.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Daniel Caruso, MD, Principal investigator, Maricopa Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731367
- Sponsor's protocol ID
- CW-0412-05-A080
- Status last verified
- Feb 2009
- First submitted
- 7 Aug 2008
- Last updated
- 3 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Sinha S, Gabriel VA, Arora RK, Shin W, Scott J, Bharadia SK, Verly M, Rahmani WM, Nickerson DA, Fraulin FO, Chatterjee P, Ahuja RB, Biernaskie JA. Interventions for postburn pruritus. Cochrane Database Syst Rev. 2024 Jun 5;6(6):CD013468. doi: 10.1002/14651858.CD013468.pub2.
PubMed 38837237Blome-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.
PubMed 19969423
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIb, Randomized Comparative Evaluation of Two AQUACEL Ag Protocols of Care for the Management of Donor Sites.
- ClinicalTrials.gov ID
- NCT00731367
- Acronym / sponsor ID
- CW-0412-05-A080
- Conditions
- Split-Thickness Donor Sites.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Oct 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 11 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gelled | Active comparator | Device: Aquacel Ag GelledAquacel Ag gelled. |
| Adherent | Active comparator | Device: Aquacel Ag AdherentAquacel Ag adherent |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquacel Ag GelledAQUACEL 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 | Gelled |
| Aquacel Ag AdherentAQUACEL 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 | Adherent |
Primary outcome
To evaluate the proportion of subjects healed.
Time frame: 14 days
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2009.
- Derived from this study: PubMed 38837237Sinha S, Gabriel VA, Arora RK, Shin W, Scott J, Bharadia SK, Verly M, Rahmani WM, Nickerson DA, Fraulin FO, Chatterjee P, Ahuja RB, Biernaskie JA. Interventions for postburn pruritus. Cochrane Database Syst Rev. 2024 Jun 5;6(6):CD013468. doi: 10.1002/14651858.CD013468.pub2.
- Derived from this study: PubMed 19969423Blome-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Caruso, MD principal investigator
Maricopa Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aquacel Ag Gelled and Aquacel Ag Adherent in people with Split-Thickness Donor Sites., run by ConvaTec Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the proportion of subjects healed. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00731367, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2009.