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Treatment of Wounds With a New Adhesive Foam Dressing

Primary Purpose

Wounds and Injuries, Burns

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
ELECT
Sponsored by
Smith & Nephew, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wounds and Injuries focused on measuring Wound, burns, acute, chronic, foam, adhesive, dressing

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Inkosi Albert Luthuli Central Hospital (IALCH)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ELECT

Arm Description

Adhesive Foam Dressing

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage change in wound depth
Percentage change in wound volume
Duration of dressing wear
The proportion of wounds that have 100% healed or closed by secondary intention.
Assessment of exudate type and amount
Assessment using a modified Bates-Jensen Would Assessment Tool1 and T.I.M.E.2,3)
Assessment of Condition of the peri-wound skin
Assessment using a modified Bates-Jensen Would Assessment Tool1 and T.I.M.E.2,3)
Assessment of the amount of tissue and skin colour
Assessment using a modified Bates-Jensen Would Assessment Tool1 and T.I.M.E.2,3)
Assessment of infection/clinical signs of infection
Assessment using Normal Clinical practice
Pain on application and removal of dressing (using a Visual Analogue Scale (VAS) or FLACC scale)
Reason for dressing change
Ease of application and removal of the ELECT dressing using the visual analogue scale
Overall clinician acceptability with the new dressing
Measured using a questionnaire
Clinician acceptability with dressing performance parameters
Measured using a questionnaire
Safety in use - all adverse events that occur during the study will be recorded

Full Information

First Posted
June 14, 2016
Last Updated
February 14, 2018
Sponsor
Smith & Nephew, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02807584
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries, Burns
Keywords
Wound, burns, acute, chronic, foam, adhesive, dressing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ELECT
Arm Type
Experimental
Arm Description
Adhesive Foam Dressing
Intervention Type
Device
Intervention Name(s)
ELECT
Primary Outcome Measure Information:
Title
Wound progression, (percentage change in area) using a wound imaging measurement and wound documentation system
Description
using a wound imaging, measurement and wound documentation system
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Percentage change in wound depth
Time Frame
14 days
Title
Percentage change in wound volume
Time Frame
14 days
Title
Duration of dressing wear
Time Frame
14 days
Title
The proportion of wounds that have 100% healed or closed by secondary intention.
Time Frame
14 days
Title
Assessment of exudate type and amount
Description
Assessment using a modified Bates-Jensen Would Assessment Tool1 and T.I.M.E.2,3)
Time Frame
14 days
Title
Assessment of Condition of the peri-wound skin
Description
Assessment using a modified Bates-Jensen Would Assessment Tool1 and T.I.M.E.2,3)
Time Frame
14 days
Title
Assessment of the amount of tissue and skin colour
Description
Assessment using a modified Bates-Jensen Would Assessment Tool1 and T.I.M.E.2,3)
Time Frame
14 days
Title
Assessment of infection/clinical signs of infection
Description
Assessment using Normal Clinical practice
Time Frame
14 days
Title
Pain on application and removal of dressing (using a Visual Analogue Scale (VAS) or FLACC scale)
Time Frame
14 days
Title
Reason for dressing change
Time Frame
14 days
Title
Ease of application and removal of the ELECT dressing using the visual analogue scale
Time Frame
14 days
Title
Overall clinician acceptability with the new dressing
Description
Measured using a questionnaire
Time Frame
14 days
Title
Clinician acceptability with dressing performance parameters
Description
Measured using a questionnaire
Time Frame
14 days
Title
Safety in use - all adverse events that occur during the study will be recorded
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert B Slade, MD
Organizational Affiliation
Smith & Nephew, Inc.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jaime E Dickerson, PhD
Organizational Affiliation
Smith & Nephew, Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alessandro Andreone, MD
Organizational Affiliation
Inkosi Albert Luthuli Central Hospital (IALCH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inkosi Albert Luthuli Central Hospital (IALCH)
City
Durban
ZIP/Postal Code
4058
Country
South Africa

12. IPD Sharing Statement

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Treatment of Wounds With a New Adhesive Foam Dressing

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