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OpenTrials
Completed

NCT Number: NCT02807584

Treatment of Wounds With a New Adhesive Foam Dressing

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.

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Key information

Conditions

Wounds and Injuries Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Burns Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inkosi Albert Luthuli Central Hospital (IALCH)

Durban, 4058, South Africa

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be ≥1 years old
  • Males and females (females must not be pregnant and must use contraception if of child bearing potential)
  • 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
  • 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)
  • 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).
  • The participant or the participant's legal representative is able to understand and is willing to consent to the study.

Exclusion criteria

  • 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)
  • Participants who are unable to understand the aims and objectives of the study.
  • Participant is a prisoner.
  • Participants with a known sensitivity to any of the constituents of the evaluation products, including polyester, polyurethane, and acrylic adhesive
  • Participants with facial wounds as the reference wound
  • Participants with confirmed or suspected clinically infected reference wounds (unless wounds are being treated per standard protocol for wound infection)
  • Participant is likely to undergo foreseeable definitive surgery within 2 weeks from screening
  • Participants where a reference wound cannot be treated in isolation from other wounds
  • Participants who have participated in this evaluation previously and closed/100% healed, or have been withdrawn from the study, or any previous studies
  • Participant who are employees of Smith & Nephew group companies

Treatment and study plan

ELECT

Device

Primary outcomes

  1. Wound progression, (percentage change in area) using a wound imaging measurement and wound documentation system

    Time frame: 14 days

    using a wound imaging, measurement and wound documentation system

Secondary outcomes

  1. Percentage change in wound depth

    Time frame: 14 days

  2. Percentage change in wound volume

    Time frame: 14 days

  3. Duration of dressing wear

    Time frame: 14 days

  4. The proportion of wounds that have 100% healed or closed by secondary intention.

    Time frame: 14 days

  5. Assessment of exudate type and amount

    Time frame: 14 days

    Assessment using a modified Bates-Jensen Would Assessment Tool1 and T.I.M.E.2,3)

  6. Assessment of Condition of the peri-wound skin

    Time frame: 14 days

    Assessment using a modified Bates-Jensen Would Assessment Tool1 and T.I.M.E.2,3)

  7. Assessment of the amount of tissue and skin colour

    Time frame: 14 days

    Assessment using a modified Bates-Jensen Would Assessment Tool1 and T.I.M.E.2,3)

  8. Assessment of infection/clinical signs of infection

    Time frame: 14 days

    Assessment using Normal Clinical practice

  9. Pain on application and removal of dressing (using a Visual Analogue Scale (VAS) or FLACC scale)

    Time frame: 14 days

  10. Reason for dressing change

    Time frame: 14 days

  11. Ease of application and removal of the ELECT dressing using the visual analogue scale

    Time frame: 14 days

  12. Overall clinician acceptability with the new dressing

    Time frame: 14 days

    Measured using a questionnaire

  13. Clinician acceptability with dressing performance parameters

    Time frame: 14 days

    Measured using a questionnaire

  14. Safety in use - all adverse events that occur during the study will be recorded

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 21, 2016
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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