The primary objective of the above study is to evaluate the wear time AQUACEL® Extra* when compared to AQUACEL® in subjects with venous leg ulcers. Stratification will be done for exudate (moderate vs highd) and type of dressing (AQUACEL®Extra*…
ID
Source
Brief title
Condition
- Other condition
- Skin vascular abnormalities
Synonym
Health condition
venous disease
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Exudate management:
- wear time
- % dressings achieving a 7 day wear time
- Time to achieve a 7 day wear time
- Condition of the peri-ulcer skin
Secondary outcome
Besides that the following will be investigated as well: Safety, Ulcer
improvement, Progress towards healing, Pain, Comfort, Ease of Use, Dressing
utilisation and costs
Background summary
Hydrofiber® dressings have played an increasingly important role in the
management of wounds since their introduction to the market in 1994. Exudate
management in wound care is very important. Hydrofiber dressings are known for
their ability to provide effective moisture balance, and their gelling
properties provide excellent control of exudate (Okan 2007). From the
literature it is shown that AQUACEL® (a sterile dressing made from a non-woven
sheet of sodium carboxymethylcellulose (NaCMC). cellulose) yarns) achieves a
mean wear time of three to four days in the management of venous leg ulcers
(Harding 2001, Armstrong 1997, Clinical Evaluation Report, August 2011). In
vitro studies have demonstrated that AQUACEL® Extra* (AQUACEL® Extra* (a soft
conformable flat sheet of non-woven fabric sandwiched into two layers and
stitch-bonded together using Lyocel (Tencel* regenerated cellulose) yarns.) is
39% more absorbent than AQUACEL®. It is anticipated that this increased
capacity will enable a longer wear time in a clinical scenario. A comparative
study is proposed to assess the performance of the AQUACEL® Extra* dressing
when compared to AQUACEL®.
Study objective
The primary objective of the above study is to evaluate the wear time AQUACEL®
Extra* when compared to AQUACEL® in subjects with venous leg ulcers.
Stratification will be done for exudate (moderate vs highd) and type of
dressing (AQUACEL®Extra* vsAQUACEL®)
Study design
The study is randomised; therefore your patient will be treated with either the
AQUACEL® Extra* or AQUACEL® for 4 weeks.
Your patients wound will be dressed according to clinical need with the aim to
leave the dressing in place for 7 days.
At each dressing change wounds will be evaluated and details related to the
wound status and condition of the wound bed will be recorded. Acetate tracings
and wound photographs will also be taken.
Intervention
The study is randomised; therefore your patient will be treated with either the
AQUACEL® Extra* or AQUACEL® for 4 weeks. Stratification will be done for
exudate (moderate vs highd) and type of dressing (AQUACEL®Extra* vsAQUACEL®).
Study burden and risks
Both AQUACEL® Extra* and AQUACEL® provide a moist environment that supports the
growth of new blood vessels, occasionally the delicate newly formed blood
vessels may produce a blood stained wound fluid.
Possible allergic reactions e.g. skin rash and irritation.
There is a possibility that the dressing*s ability to remove dead tissue and
debris may result in the wound appearing larger of the first few dressing
changes. Rarely irritation of the skin surrounding the ulcer may occur.
There are no specific adverse events known for these dressings.
Study will last 4 weeks, 30 minutes per visit. Number of visits is dependent on
dressing changes.
Milton Road,
ICKENHAM, MIDDLESEX UB10 8PU
GB
Milton Road,
ICKENHAM, MIDDLESEX UB10 8PU
GB
Listed location countries
Age
Inclusion criteria
The following subjects may be included in the study:;•Subjects over 18 years, willing and able to provide written informed consent.
•Subjects who have an ankle to brachial pressure index (ABPI) of 0.8 or greater
•Subjects who have a venous leg ulcer (i.e. CEAP classification of C6 1) with duration less than 24 months
•Subjects whose ulcer is no larger than 2cm x 11cm
•Subjects who have only one ulcer on the index leg
•Subjects* whose index leg ulcer has a moderate to heavy level of exudate (a definition of exudate levels will be provided).
•Subjects whose index (study) leg is currently being treated with compression therapy and whose leg oedema is under control
•Subjects who are willing and able to comply with the requirements of the clinical investigation plan in relation to the dressing/compression regime and the ability to attend dressing changes as required.
Exclusion criteria
The following subjects must not be included into the study:;•Subjects with a history of skin sensitivity to any of the components of the study dressings.
•Subjects whose wounds are considered clinically infected at baseline
•Subjects whose leg is oedematous (level of oedema TBC)
•Subjects whose leg ulcers are malignant, or who have had recent deep venous thrombosis or venous surgery within the last 3 months.
•Subjects who have progressive neoplastic lesion treated by radiotherapy or chemotherapy, or on-going treatment with immunosuppressive agents
•Subjects exhibiting any other medical condition which, according to the Investigator, justifies the subject*s exclusion from the study
•Subjects who have participated in a clinical study within the past month.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39382.028.12 |