Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000587707
Ethics application status
Approved
Date submitted
9/04/2022
Date registered
20/04/2022
Date last updated
20/04/2022
Date data sharing statement initially provided
20/04/2022
Date results information initially provided
20/04/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Skin repair after excisions using a novel dressing; a clinical pilot study
Scientific title
Pilot study using a structured magnetic field after skin excisions in 30 adults, testing wound strength by the early removal of sutures.
Secondary ID [1] 306792 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin repair 325848 0
Condition category
Condition code
Skin 323167 323167 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention tested a novel wound dressing as a test device which contained one active half and a control half.
Materials- latex strip containing ferromagnetic materials emitting a structured magnetic field.
Procedure- the device was placed external to a conventional wound dressing and fixed in position for up to 3 days only. The device was applied to a skin excision wound after the conventional excision procedure. The wound was tested after removing the test device and photographing the wound and if the wound was clinically assessed as healed then sutures were removed from the end of the wound which appeared to have the more mature repair. Photos were also taken after any procedure and at standard review periods in the trial.
The team that conducted the trial included a general practitioner with over 20 years clinical experience who performed all clinical assessments and procedures with 1-2 registered nurses and sometimes 1 general surgeon observing and assisting.
The trial was conducted at the Southern Cross University Health Clinic on the Lismore campus as a series of clinical consultations.
The recruitment to the trial was at a consultation where the patient was referred to have an excision by another doctor either from the clinic or another location. Informed written consent was obtained prior to the excision which was performed on day 0 of the trial and the device was applied after the wound had been covered, to remain in place until the first clinical review which was at day 3,2 or 1 depending on the stage of the trial. At the first review the device was removed and discarded, the dressings taken down and the wound assessed by the team. If the team could discern a more mature repair in one half of the wound then the wound was tested by removing sutures from that half of the wound. Wounds were photographed before and after all procedures in the trial at every review.
Delayed outcomes were tested by reviewing the wounds again at day 7 and day 14.
Intervention code [1] 323251 0
Treatment: Devices
Comparator / control treatment
One half of each test device was a control where all aspects of the material was identical except for the magnetic field strength. The control field strength was only detectable with a gaussmeter. It was intended that the control would be completely inert however subsequent testing of the control with a gaussmeter in-situ measured a small residual field.
Control group
Dose comparison

Outcomes
Primary outcome [1] 330918 0
Whether there was a clinically evident difference between each half of the wound as assessed by physical examination, gaining consensus between 2 or more blinded clinical assessors, confirmed by digital photography of the wounds.
Timepoint [1] 330918 0
At day 3 after the excision, then day 2 and day 1 as more participants passed through the trial.
Primary outcome [2] 330919 0
Whether the wound remained closed after sutures were removed from the half of the wound at first review as assessed by physical examination, gaining consensus between 2 or more blinded clinical assessors, and confirmed by digital photography.
Timepoint [2] 330919 0
At day 3, then day 2 and day 1 as more participants passed through the trial.
Secondary outcome [1] 408084 0
Dehiscence, whether the wound remained entirely closed after sutures were removed as assessed by physical examination, gaining consensus between 2 or more blinded clinical assessors, and confirmed by digital photography.
Timepoint [1] 408084 0
Tested at day 7 and day 14 after the excision.
Secondary outcome [2] 408087 0
Subjects provided feedback on the experience of wearing the device and participating in the trial using a questionnaire specifically designed for the study using a 7 point scale for responses; Very Bad, Mostly Bad, Sometimes Bad, Neither, Sometimes Good, Mostly Good, Very Good.
Timepoint [2] 408087 0
Recorded after the device was removed and at each subsequent review on day 7 and day 14.

Eligibility
Key inclusion criteria
Adult with a skin lesion to be excised according to a practitioner external to the study; including diagnostic excision of suspicious lesions, therapeutic excisions of malignant lesions and excision of unwanted benign lesions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Unable to give consent in English

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each device contained a randomly assigned active half and a control half.
Both active and control versions were identical except for the magnetic field. The assembly and labelling of each half of the device was performed external to the study location and that information was kept off site and concealed from the doctor enrolling the subjects and the team throughout the clinical activities of the trial..
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The half of the wound given the active end of the device was randomly allocated and photographed to show the labelled device in place.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Single group
Other design features
The duration of the application of the device was progressively shortened as subjects passed through the trial. The first group of 6 subjects were treated for 3 days, observed and 2 subjects had sutures removed early. Since the outcomes were considered satisfactory then the next 7 subjects were treated for 3 days, 5 subjects had sutures removed early. Since the outcomes were considered satisfactory then the next 10 subjects were treated for 2 days, 9 subjects had sutures removed early. Since the outcomes were considered satisfactory then the next 7 subjects were treated for 1 day, all had sutures removed early. A default strategy was to observe and leave sutures in place until a later review if the difference was unclear.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size of30 was deemed sufficient due to the binary nature of the data and the central limit theorem.. The subject variables were controlled by testing the active device vs a control within the same wound.
The observed difference between each half of the wound was compared to the actual active and control halves of the dressing.
The rate of wound dehiscence was compared to the reported rate of dehiscence in excision wounds within the general population (5%).
De-identified photos were assessed by blinded external reviewers to determine the estimated wound age and the presence of any complications.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
31/10/2016
Date of last participant enrolment
Anticipated
Actual
6/06/2018
Date of last data collection
Anticipated
Actual
20/06/2018
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22148 0
Southern Cross University Health Clinic - Lismore
Recruitment postcode(s) [1] 37270 0
2480 - Lismore

Funding & Sponsors
Funding source category [1] 311129 0
Self funded/Unfunded
Name [1] 311129 0
Dr Rosemary Craig
Country [1] 311129 0
Australia
Primary sponsor type
Individual
Name
Dr Rosemary Craig
Address
Contractor General Practitioner
PO Box 775
Alstonville NSW 2477
Country
Australia
Secondary sponsor category [1] 312473 0
None
Name [1] 312473 0
Address [1] 312473 0
Country [1] 312473 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310658 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 310658 0
PO Box 157
Lismore NSW 2480
Ethics committee country [1] 310658 0
Australia
Date submitted for ethics approval [1] 310658 0
20/06/2016
Approval date [1] 310658 0
04/07/2016
Ethics approval number [1] 310658 0
ECN-16-181

Summary
Brief summary
The pilot study was to determine the safety and efficacy of a device which aimed to modify the repair of the extracellular matrix in skin.
The hypothesis was that the structured magnetic field of the active device would enable a more efficient repair through enabling the alignment of molecules flowing into the wound thus decreasing the healing time and improving the strength of the repair. Although the intervention was intending to nanoengineer the repair, the outcomes were measured at a macroscopic level by taking photos of the wounds, removing sutures early to test wound strength and including the subject's experience of wearing the device.
The control device was a weak active control, which permitted the discernment of a difference between each end to the wound corresponding to the active vs control devices yet enabled the clinical assessment of a weak dosage effect on the repair where the control end was found to have a significant clinical effect on wound strength.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118422 0
Dr Rosemary Craig
Address 118422 0
Southern Cross University Health Clinic
PO Box 157
Lismore NSW 2480
Country 118422 0
Australia
Phone 118422 0
+610412643264
Fax 118422 0
Email 118422 0
rosemary.craig@scu.edu.au
Contact person for public queries
Name 118423 0
Dr Rosemary Craig
Address 118423 0
Southern Cross University Health Clinic
PO Box 157
Lismore NSW 2480
Country 118423 0
Australia
Phone 118423 0
+61266269131
Fax 118423 0
Email 118423 0
rosemary.craig@scu.edu.au
Contact person for scientific queries
Name 118424 0
Dr Rosemary Craig
Address 118424 0
Southern Cross University Health Clinic
PO Box 157
Lismore NSW 2480
Country 118424 0
Australia
Phone 118424 0
+61266269131
Fax 118424 0
Email 118424 0
rosemary.craig@scu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.