Clinical trial NCT02807584: Treatment of Wounds With a New Adhesive Foam Dressing
Official title: A Prospective, Open Study to Evaluate the Clinical Performance of a New Adhesive Foam Dressing in the Treatment of Partial Thickness Burns, Acute and Chronic Wounds.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wounds and Injuries
Burns
Keywords: Wound
burns
acute
chronic
foam
adhesive
dressing
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-21
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will look at whether ELECT, a new adhesive foam dressing, can offer an alternative to traditional wound care methods.

Patients will be treated with ELECT for 14 days. Data relating to wound healing, the performance of the dressing and the opinion of the doctor will be collected.

The hypothesis of this study is that the ELECT foam adhesive dressing is 'fit for purpose' and will be effective at treating a variety of wounds.


Eligibility criteria: INCLUSION CRITERIA

1. Participants must be ≥1 years old
2. Males and females (females must not be pregnant and must use contraception if of child bearing potential)
3. Participant must have a partial thickness burn, acute or chronic wound that would benefit from the application of an advanced wound dressing to help facilitate moist wound healing
4. Presence of a suitable wound which can be treated with the available sizes of the ELECT Adhesive Foam Dressing (7.5cm x 7.5cm, 12.5cm x 12.5cm, 15cm x 15cm and 17.5cm x 17.5cm)
5. Participant is under the direct observation of the investigator for the duration of the study (i.e the participant's wound must not be treated by another clinician throughout the duration of the study).
6. The participant or the participant's legal representative is able to understand and is willing to consent to the study.

EXCLUSION CRITERIA

1. Participants with a known history of poor compliance with treatment (including if the participant has a known , diagnosed emotional or neurological condition such as mental disorders/illnesses, mental retardation, drug or alcohol abuse, that would pre-empt their ability to understand and consent)
2. Participants who are unable to understand the aims and objectives of the study.
3. Participant is a prisoner.
4. Participants with a known sensitivity to any of the constituents of the evaluation products, including polyester, polyurethane, and acrylic adhesive
5. Participants with facial wounds as the reference wound
6. Participants with confirmed or suspected clinically infected reference wounds (unless wounds are being treated per standard protocol for wound infection)
7. Participant is likely to undergo foreseeable definitive surgery within 2 weeks from screening
8. Participants where a reference wound cannot be treated in isolation from other wounds
9. Participants who have participated in this evaluation previously and closed/100% healed, or have been withdrawn from the study, or any previous studies
10. Participant who are employees of Smith \& Nephew group companies

Primary outcomes:
measure: Wound progression, (percentage change in area) using a wound imaging measurement and wound documentation system
timeFrame: 14 days
Secondary outcomes:
measure: Percentage change in wound depth
timeFrame: 14 days
measure: Percentage change in wound volume
timeFrame: 14 days
measure: Duration of dressing wear
timeFrame: 14 days
measure: The proportion of wounds that have 100% healed or closed by secondary intention.
timeFrame: 14 days
measure: Assessment of exudate type and amount
timeFrame: 14 days
measure: Assessment of Condition of the peri-wound skin
timeFrame: 14 days
measure: Assessment of the amount of tissue and skin colour
timeFrame: 14 days
measure: Assessment of infection/clinical signs of infection
timeFrame: 14 days
measure: Pain on application and removal of dressing (using a Visual Analogue Scale (VAS) or FLACC scale)
timeFrame: 14 days
measure: Reason for dressing change
timeFrame: 14 days
measure: Ease of application and removal of the ELECT dressing using the visual analogue scale
timeFrame: 14 days
measure: Overall clinician acceptability with the new dressing
timeFrame: 14 days
measure: Clinician acceptability with dressing performance parameters
timeFrame: 14 days
measure: Safety in use - all adverse events that occur during the study will be recorded
timeFrame: 14 days
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: Inkosi Albert Luthuli Central Hospital (IALCH)
Study officials:
affiliation: Smith & Nephew, Inc.
name: Herbert B Slade, MD
role: STUDY_CHAIR
affiliation: Smith & Nephew, Inc.
name: Jaime E Dickerson, PhD
role: STUDY_DIRECTOR
affiliation: Inkosi Albert Luthuli Central Hospital (IALCH)
name: Alessandro Andreone, MD
role: PRINCIPAL_INVESTIGATOR
References: