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Trial registered on ANZCTR


Registration number
ACTRN12621000384853
Ethics application status
Approved
Date submitted
21/01/2021
Date registered
7/04/2021
Date last updated
11/08/2022
Date data sharing statement initially provided
7/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of dressings for management of pain for minor skin excision wounds.
Scientific title
A randomised controlled trial of an ibuprofen-impregnated dressing and early versus delayed dressing removal for management of pain for minor skin excision wounds.
Secondary ID [1] 303122 0
none
Universal Trial Number (UTN)
U1111-1264-0976
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
skin lesion 320905 0
Condition category
Condition code
Skin 318158 318158 0 0
Dermatological conditions
Skin 318723 318723 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: dressing impregnated with ibuprofen applied to wound for 48 hours, after which wound remains uncovered until suture removal
Arm 2: dressing impregnated with ibuprofen applied to wound for 48 hours, after which wound is covered with another plain dressing until suture removal
Arm 3: plain non-medicated dressing applied to the wound for 48 hours, after which wound remains uncovered until suture removal
Arm 4: plain non-medicated dressing applied to the wound for 48 hours, after which wound is covered with another plain dressing until suture removal

Dressing Details
The ibuprofen-impregnated dressing contains 0.5mg/cm2 of ibuprofen homogenously dispersed through a foam matrix. The ibuprofen-impregnated dressing and the plain non-medicated dressing consist of a polyurethane foam. The dressing will be applied by a general practitioner or nurse. The dressing application will occur in a general practice clinic. The approximate duration of time between removal of the dressing and suture removal is 7-14 days. Adherence to the intervention will be monitored by the researchers who will phone participants on day 3 post-surgery
Intervention code [1] 319422 0
Treatment: Devices
Intervention code [2] 319843 0
Treatment: Drugs
Comparator / control treatment
Plain non-medicated dressing applied to the wound for 48 hours, after which wound is covered with another plain dressing until suture removal
Control group
Active

Outcomes
Primary outcome [1] 326144 0
Mean difference in pain scores at 24 hours. Comparison will be pain score of wounds covered with an ibuprofen- impregnated dressing compared to wounds covered with a plain non-medicated dressing. Pain will be measured on a 100mm visual analog scale, as a self assessment by participants..

Timepoint [1] 326144 0
24 hours post excision.
Primary outcome [2] 326266 0
Mean difference in pain scores at 72 hours. Comparison will be of wounds covered with a plain dressing compared to wounds not covered with a dressing.
Pain will be measured on a 100mm visual analog scale, as a self assessment by participants.
Timepoint [2] 326266 0
72 hours post excision
Secondary outcome [1] 390239 0
Mean difference in pain scores at 12 and 48 hours. Comparison will be pain score of wounds covered with an ibuprofen- impregnated dressing compared to wounds covered with a plain non-medicated dressing. Pain will be measured on a 100mm visual analog scale, as a self assessment by participants..
Timepoint [1] 390239 0
12 and 48 hours post excision.
Secondary outcome [2] 390816 0
Mean difference in pain scores at 96 hours. Comparison will be of wounds covered with a plain dressing compared to wounds not covered with a dressing.
Pain will be measured on a 100mm visual analog scale, as a self assessment by participants.
Timepoint [2] 390816 0
96 hours post excision.
Secondary outcome [3] 390817 0
Post-operative oral analgesia requirement within the first 48 hours post excision for wounds covered with an ibuprofen-impregnated dressing compared to wounds covered with a plain non-medicated dressing. Oral analgesia use will be recorded by participants in a paper diary format.
Timepoint [3] 390817 0
Up to 48 hours post excision.
Secondary outcome [4] 392311 0
Infection rate of wounds covered with a dressing for only 48 hours compared to wounds covered until suture removal (7-14 days post-excision).

Infection rates will be measured as surgical site infection as defined by Centres of Disease Control:
Infection within 30 days of excision
Purulent discharge from the wound OR
Organisms isolated from culture of fluid or tissue from the incision OR
The GP diagnoses a wound infection on the basis of clinical features of pain, swelling redness and heat OR
The GP prescribes antibiotics
Stitch abscess is excluded (minimal inflammation and discharge confined to the points of suture penetration)
Timepoint [4] 392311 0
From 48 hours post excision to suture removal (7-14 days post excision).
Secondary outcome [5] 392312 0
Participant comfort level of wounds covered with a dressing for only 48 hours compared to wounds covered until suture removal. Participant comfort levels will be measured using standard questions designed specifically for this study and asked by the researchers or nurse.
Timepoint [5] 392312 0
At 72 hours post excision and at suture removal (7-14 days post excision).
Secondary outcome [6] 392315 0
Any adverse events in the ibuprofen- impregnated dressing group compared to wounds covered with a plain non-medicated dressing group. Adverse events will be assessed by participant or general practitioner report.
Timepoint [6] 392315 0
Up to 48 hours post excision..
Secondary outcome [7] 392316 0
Any adverse events in wounds covered with a plain dressing from 48 hours compared to wounds not covered with a dressing. Adverse events will be assessed by participant or general practitioner report.
Timepoint [7] 392316 0
From 48 hours to suture removal (7-14 days post excision).

Eligibility
Key inclusion criteria
Patients presenting to their general practitioner for minor surgical excision of a skin lesion
18 years of age or over
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Excision of lesions on the face
Patients already on oral antibiotics
Patients on immunosuppressive drugs
Traumatic wounds
Patients who are unable to communicate effectively either due to language barrier or cognitive impairment
Patients with a known contraindication, allergy or adverse reaction to ibuprofen or any component of the dressing.
Patients with a wound that has skin integrity concerns eg difficult closure with poorly perfused skin
Pregnancy or breastfeeding

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)
Central randomisation by phone or computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
For the ibuprofen-impregnated versus plain dressing component of the trial, participants and data analysts/ assessors will be blinded to the treatment group, however the clinicians will be unable to be blinded.
For the plain dressing compared to no dressing component of the trial, the participants, and clinicians will be unable to be blinded, however the assessors/data analysts will be blinded.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The first comparison is difference in pain levels between the control and intervention dressings at 12, 24 and 48 hours, with 24 hours being the primary outcome. This is a continuous variable. Mean difference (MD) and 95% confidence intervals will be calculated. A difference of 30% on the visual analog scale is considered clinically significant. Comparison will be between non-medicated and medicated dressing groups.

The second comparison is mean difference in pain levels between the no dressing group and delayed dressing group at 72 and 96 hours, with 72 hours being the primary outcome. It is not expected that the ibuprofen impregnated dressing will have any ongoing effect on pain once it is removed at 48 hours and replaced by a plain dressing, therefore this second comparison is considered independent. However, an analysis will be done to check this hypothesis. The randomisation protocol will aim to have equivalent numbers of participants from the control and intervention dressings in each arm of the second component of the study.

As these two comparisons are independent (due to a wash out of pain medication after initial dressing removal at 48 hours), the following sample size calculation is applicable to both as primary outcomes. The mean differences (at the other time points) will be treated as secondary outcomes.

Based on a continuous pain scale (range 0-100 VAS), previous data indicating expected sample variance of 16 units, a clinically meaningful difference of 30% (assuming control mean pain score of 20, and therefore an intervention score of 14); with 80% power and alpha = 5%, the required number of participants is 148. Allowing 15% for dropout, 170 participants should be recruited.

Secondary outcomes
Infection rate at suture removal will be a comparison between dressing removal at 48 hours and the delayed dressing group. Infection rate will be a dichotomous variable, and will be calculated as a risk ratio (RR) with 95% confidence intervals.

A comparison of the use of post-operative oral analgesia between the ibuprofen impregnated dressing group and the plain dressing group will be a dichotomous variable, and will be calculated as a risk ratio (RR) with 95% confidence intervals.
Adverse events will be monitored and reported as a dichotomous variable and calculated as a risk ratio with 95% confidence intervals. This will be calculated comparing the ibuprofen dressing group with the plain dressing group, and separately calculated comparing the 48-hour group with the delayed dressing group.

Qualitative analysis
Participant comfort data collected at 72 hours and at suture removal will be analysed and reported thematically.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/04/2021
Actual
19/05/2021
Date of last participant enrolment
Anticipated
16/09/2022
Actual
Date of last data collection
Anticipated
30/09/2022
Actual
Sample size
Target
170
Accrual to date
125
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 32786 0
2340 - Tamworth
Recruitment postcode(s) [2] 32787 0
2350 - Armidale
Recruitment postcode(s) [3] 32788 0
2360 - Inverell
Recruitment postcode(s) [4] 32789 0
2370 - Glen Innes
Recruitment postcode(s) [5] 32790 0
2346 - Manilla
Recruitment postcode(s) [6] 32791 0
2343 - Quirindi
Recruitment postcode(s) [7] 32792 0
2358 - Uralla
Recruitment postcode(s) [8] 32793 0
2365 - Guyra

Funding & Sponsors
Funding source category [1] 307530 0
Government body
Name [1] 307530 0
New South Wales Regional Health Partners
Country [1] 307530 0
Australia
Primary sponsor type
University
Name
University of New England
Address
School of Rural Medicine
University of New England
Madgwick Drive
Armidale NSW 2351
Country
Australia
Secondary sponsor category [1] 308325 0
None
Name [1] 308325 0
Address [1] 308325 0
Country [1] 308325 0
Other collaborator category [1] 281600 0
University
Name [1] 281600 0
University of Newcastle Department of Rural Health
Address [1] 281600 0
University of Newcastle Department of Rural Health
Faculty of Health and Medicine
The University of Newcastle
114-148 Johnston Street
Tamworth NSW 2340
Country [1] 281600 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307595 0
University of New England Human Research Ethics Committee
Ethics committee address [1] 307595 0
Ethics committee country [1] 307595 0
Australia
Date submitted for ethics approval [1] 307595 0
19/11/2020
Approval date [1] 307595 0
19/01/2021
Ethics approval number [1] 307595 0
HE20-216

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107802 0
A/Prof Michelle Guppy
Address 107802 0
School of Rural Medicine
University of New England
Madgwick Drive
Armidale NSW 2350
Country 107802 0
Australia
Phone 107802 0
+61 267733579
Fax 107802 0
Email 107802 0
michelle.guppy@une.edu.au
Contact person for public queries
Name 107803 0
Joy Bowles
Address 107803 0
School of Rural Medicine
University of New England
Madgwick Drive
Armidale NSW 2350
Country 107803 0
Australia
Phone 107803 0
+61 267733721
Fax 107803 0
Email 107803 0
ebowles@une.edu.au
Contact person for scientific queries
Name 107804 0
Michelle Guppy
Address 107804 0
School of Rural Medicine
University of New England
Madgwick Drive
Armidale NSW 2350
Country 107804 0
Australia
Phone 107804 0
+61 267733579
Fax 107804 0
Email 107804 0
michelle.guppy@une.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
deidentified individual participant data collected during the trial
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
On a case-by-case basis at the discretion of the Primary Sponsor
Available for what types of analyses?
For meta-analyses
How or where can data be obtained?
By contacting Principal investigator
email: michelle.guppy@une.edu.au
phone: +61 2 67733579


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.