Safety and Performance of Dressing Adhesive on Healthy VolunteersNCT01897285

A Single Centre, Randomised, Comparative, Blinded Wear Test of Two Adhesives on the AQUACEL® Foam Adhesive Dressing

A study testing AQUACEL® foam adhesive dressing in people with Safety and Performance of Dressing Adhesive on Healthy Volunteers, run by ConvaTec Inc. at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Safety and Performance of Dressing Adhesive on Healthy Volunteers
What is being tested?: AQUACEL® foam adhesive dressing
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited Kingdom
Study dates: May 2013to May 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Provide written informed consent
Be a healthy volunteer and be over 18 years of age
Be willing to attend two scheduled visits for application and removal of the device and adverse event review
Have healthy unbroken skin

Who cannot join

Subjects with a history of sensitivity to any one of the components of the device being studied
Female subjects who are currently pregnant or lactating
Subjects who are not willing and able to attend the 'clinic' for the required assessments
Subjects with excessive hair on their backs
Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Global Development Centre, Deeside Industrial Park
Deeside, Flintshire, CH5 2NU

Other trials in United Kingdom

About this study

AQUACEL® foam adhesive dressing is a sterile Hydrofiber® foam wound dressing consisting of a waterproof outer polyurethane film, and a multi-layered absorbent pad, having a silicone adhesive border. The multi-layered absorbent pad contains a layer of polyurethane foam and a non-woven wound contact layer of Hydrofiber® (NaCMC). This dressing product was launched in 2012. A new source of silicone adhesive is now under assessment for this product. This Healthy Volunteer Wear test will form part of the Design Validation for this change in supplier and is required to confirm that the new Silicone Adhesive trilaminate supplier can coat the silicone adhesive to provide comparable adhesive dressing performance in terms of wear time, ease of use and with a similar safety profile in relation to the skin.

Conditions: Safety and Performance of Dressing Adhesive on Healthy Volunteers
Being tested: AQUACEL® foam adhesive dressing
Keywords: Performance and safety of the AQUACEL® foam adhesive dressing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AQUACEL® foam adhesive dressingDevice

Study groups in NCT01897285
Study group	Role	What they receive
All study participants: AQUACEL® foam adhesive dressings	Experimental	Original adhesive + test adhesive Receives: Device: AQUACEL® foam adhesive dressing

What is being measured

The primary outcome is the main question the study is designed to answer.

Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
- Adhesion at 7 days measured by: 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor
- Conformability 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor
- Dressing Integrity 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor
- Ease of Application 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor
- Ease of Removal, 1 = Very easy 2 = Easy 3 = Difficult 4 = Very difficult
- Adhesive Residue 0 = None 1 = Minimal 2 = Moderate 3 = Considerable
- Comfort during removal 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor
- Condition of the skin This will be evaluated by the Skin Irritation Scale (Doubtful reaction/weak positive reaction/ strong positive reaction/ extreme positive reaction/irritant reaction/ negative reaction)
Measured: 7 days

Secondary outcomes (1)

Safety - the Nature and Frequency of Adverse Events
Safety will be determined by the nature and frequency of Adverse Events. Condition of the skin under and around the dressings along with the incidence of skin irritation will be assessed. The incidence and nature of all adverse events will be recorded.
Condition of the skin was evaluated by the Skin Irritation Scale. The possible responses are doubtful reaction, weak positive reaction, strong positive reaction, extreme positive reaction, irritant reaction, and negative reaction.
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013May 2013

First posted11 Jul 2013 (estimated)
Study startMay 2013
Primary completionMay 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Safety and Performance of Dressing Adhesive on Healthy VolunteersStudies 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 N/A
Allocation: Not applicable
Intervention model: Single group
Masking: Single blind
Who is masked: Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01897285
Sponsor's protocol ID: CW-0209-13-U368
Status last verified: May 2016
First submitted: 10 May 2013
Last updated: 17 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Centre, Randomised, Comparative, Blinded Wear Test of Two Adhesives on the AQUACEL® Foam Adhesive Dressing
ClinicalTrials.gov ID: NCT01897285
Acronym / sponsor ID: CW-0209-13-U368
Conditions: Safety and Performance of Dressing Adhesive on Healthy Volunteers
Keywords: Performance and safety of the AQUACEL® foam adhesive dressing
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: ConvaTec Inc.Industry (pharma, biotech, devices)
Study start: May 2013
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 11 Jul 2013 (estimated)
Results: Posted 15 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Not applicable
Intervention model: Single group
Masking: Single blind (investigator)
Number of arms: 1

Arm	Type	Receives
All study participants: AQUACEL® foam adhesive dressings	Experimental	Device: AQUACEL® foam adhesive dressingOriginal adhesive + test adhesive

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Provide written informed consent
Be a healthy volunteer and be over 18 years of age
Be willing to attend two scheduled visits for application and removal of the device and adverse event review
Have healthy unbroken skin

Key exclusion criteria (5 listed)

Subjects with a history of sensitivity to any one of the components of the device being studied
Female subjects who are currently pregnant or lactating
Subjects who are not willing and able to attend the 'clinic' for the required assessments
Subjects with excessive hair on their backs
Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study

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® foam adhesive dressing	Device	All study participants: AQUACEL® foam adhesive dressings

Primary outcome

Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
Time frame: 7 days
* Adhesion at 7 days measured by: 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor * Conformability 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor * Dressing Integrity 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor * Ease of Application 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor * Ease of Removal, 1 = Very easy 2 = Easy 3 = Difficult 4 = Very difficult * Adhesive Residue 0 = None 1 = Minimal 2 = Moderate 3 = Considerable * Comfort during removal 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor * Condition of the skin This will be evaluated by the Skin Irritation Scale (Doubtful reaction/weak positive reaction/ strong positive reaction/ extreme positive reaction/irritant reaction/ negative reaction)

1 secondary outcome

Safety - the Nature and Frequency of Adverse Events
Time frame: 7 days

Results and safety

Results posted to the registry on 15 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	20	20

Primary outcome: Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)

Time frame: 7 days. Number. Unit: participants

Measure	AQUACEL® Foam Adhesive Dressing - Original Adhesive n = 20	AQUACEL® Foam Adhesive Dressing - Test Adhesive n = 20
Arm Adhesion Excellent	6	5
Arm Adhesion Good	1	0
Arm Adhesion Average	1	1
Arm Adhesion Poor	0	0
Arm Adhesion Very Poor	12	14
Arm Dressing conformability Missing	12	14
Arm Dressing conformability Excellent	6	5
Arm Dressing conformability Good	2	1

Population analysed: 20/20 subjects completed maximum study participation of 7 days. Two subjects dressings detached very early on so returned for their final evaluation on the second day. The final subject status was recorded as 'other' for these two subjects. Many dressings detached when volunteers were away from the clinic and prior to returning for the assessments.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 7 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AQUACEL® Foam Adhesive Dressing - Original Adhesive	0 of 20 (0%)	8 of 20 (40%)	Not reported
AQUACEL® Foam Adhesive Dressing - Test Adhesive	0 of 20 (0%)	5 of 20 (25%)	Not reported

Limitations and caveats (from the sponsor): Many dressings detached from the skin when the volunteers were at home/away from the clinic and prior to returning for the assessments. It was therefore not possible for the Investigator to give a rating for several parameters on several volunteers.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Gwen Lawrence, RGN principal investigator

Wirral University Teaching Hospital NHS Trust

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AQUACEL® foam adhesive dressing in people with Safety and Performance of Dressing Adhesive on Healthy Volunteers, run by ConvaTec Inc. at 1 site in United Kingdom.

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 4 inclusion and 5 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 17 Jun 2016. 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 Kingdom. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) (time frame: 7 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 NCT01897285.

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 17 Jun 2016.