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Trial registered on ANZCTR


Registration number
ACTRN12617000813381
Ethics application status
Approved
Date submitted
5/05/2017
Date registered
5/06/2017
Date last updated
5/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of two methods of scar care for the prevention of abnormal scarring following heart surgery in children.
Scientific title
Assessment of efficacy of Stratamed (Registered Trademark) and Strataderm (Registered Trademark) versus current standard practice in the treatment and prevention of abnormal scarring of sternotomy incisions in the paediatric population
Secondary ID [1] 291504 0
Stratpharma AG internal trial identification code: SPASM04AU001.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric Sternotomy Scar Management 303141 0
Condition category
Condition code
Skin 302586 302586 0 0
Other skin conditions
Surgery 302587 302587 0 0
Other surgery
Cardiovascular 302588 302588 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants assigned to the treatment group will have Stratamed (Registered Trademark) applied to the sternotomy incision immediately following wound suturing in Operating Suite. The wound needs to be clean. Maintaining a sterile technique, pat dry as much excess exudate or wound fluid from the wound as possible prior to the application of Stratamed (Registered Trademark). Apply a thin layer of Stratamed then cover with secondary Comfeel (Registered Trademark) dressing.

The Comfeel (Registered Trademark) dressing will be removed on Day 7 post-operatively or earlier if the patient is being discharged from hospital prior to Day 7. The Comfeel (Registered Trademark) dressing is to be removed no earlier than Day 4. On dressing removal, the wound is assessed. If the wound has epithelialized, the participant will commence treatment with Strataderm (Registered Trademark) applied once daily for three months. The first application will be completed by a member of the research team and will provide an opportunity for the parent/carer to observe the application for future reference as the parents/carers will be responsible for the ongoing daily application of the product. The scar needs to be clean and dry. It can be pat dry with a towel as usual, for example, following the participant's bath. Using clean, washed hands, apply a very thin layer of Strataderm to the scar and allow to dry. When applied correctly, Strataderm should be dry in 3-4 minutes. If it takes longer to dry, too much product has been applied. Gently remove the excess with a tissue and allow the drying process to continue.

If at time of dressing removal the wound is assessed as not yet epithelialized, a thin layer of Stratamed (Registered Trademark) will be applied twice daily until Day 14 post-operatively, using a non-touch aseptic technique. From Day 15, treatment with Strataderm (Registered Trademark) will commence once daily until three months post-operatively.

At the three month assessment, treatment with Strataderm (Registered Trademark) will cease if the scar is assessed as width 1mm or less and scar colour the same as the surrounding skin. Any participant with a scar greater than 1mm in width and/or scar darker than the surrounding skin colour will continue treatment with Strataderm (Registered Trademark) as previously instructed for a duration of 12 months.

Participants adherence will be monitored with a daily record of application completed by the parent/carer in addition to monthly phone calls to all participants parent/carer while the participant is continuing to use the product.

Ingredients:
Stratamed (Registered Trademark): Polysiloxanes, siloxane resin
Strataderm (Registered Trademark): Polymethylsiloxanes, siloxanes, alkylmethyl silicones
Intervention code [1] 297575 0
Treatment: Devices
Comparator / control treatment
A parallel group will use current standard treatment of Sorbolene with vitamin E applied topically once daily from Day 14 post-operatively for a period of three months. As with current practice, the participants will be able to apply any Sorbolene with Vitamin E brand of their choice. A thin layer of Sorbolene with Vitamin E is applied directly to the wound with clean, washed hands once daily by the parent/carer. The scar will be assessed at three months as described above and treatment will cease if the scar is assessed to be 1mm or less in width and the scar colour is the same as the surrounding skin, treatment will cease. If the scar is wider than 1mm and/or the scar is darker than the surrounding unaffected skin, the treatment will continue for 12 months post-operatively.
Control group
Active

Outcomes
Primary outcome [1] 301548 0
To determine the effect upon scarring of infants primary median sternotomy wounds post cardiac surgery in infants receiving Stratamed(Registered Trademark)/Strataderm(Registered Trademark) treatment compared to standard care (Sorbolene with Vitamin E), measured by scar width and scar colour.

The photographs will be taken at four stages during the trial; on day of dressing removal (Day 4-7 post-operatively), then at 3, 6, and 12 months post-operatively. The photograph will occur with two identical stickers placed horizontally and vertically to the sternotomy. The stickers contain both a ruler to obtain width measurement and a colour scale of six colours to grade colour of the sternotomy. At the three-month blinded photographic assessment, the scar will be graded according to width and colour. If the scar is assessed to be 1mm or less in width and the scar colour is the same as the surrounding skin, treatment will cease. If the scar is wider than 1mm and/or the scar is darker than the surrounding unaffected skin, the treatment will continue for 12 months post-operatively.

The parents will take the photographs using their camera on their smartphone. Parents will be educated by the Principal Investigator (PI) or trained Clinical Evaluators during the first photographic assessment on day of dressing removal and will be provided with photography guidelines and ongoing support via phone as required. The PI and Clinical Evaluators will all have received training from the hospital photography department before educating parents in photography.

Parents will take the 3, 6 and 12 months photographs at home and send them to the PI via password protected email or multimedia message service (MMS).

The photographs will be saved on a password protected external hard drive and taken to the medical photography department for balancing and standardising. The participants' faces will be cropped from the photographs. The photographs will be printed in the medical photography department and then graded by the blinded assessor using the inbuilt measurements in the stickers to assess width and colour.
Timepoint [1] 301548 0
3 months post operatively.
Secondary outcome [1] 332997 0
To determine the effect upon scarring of infants primary median sternotomy wounds post cardiac surgery in infants receiving Stratamed(Registered Trademark)/Strataderm(Registered Trademark) treatment compared to standard care (sorbolene with Vitamin E), measured by scar width and scar colour.

The photographs will be taken at four stages during the trial; on day of dressing removal (Day 4-7 post-operatively), then at 3, 6, and 12 months post-operatively. The photograph will occur with two identical stickers placed horizontally and vertically to the sternotomy. The stickers contain both a ruler to obtain width measurement and a colour scale of six colours to grade colour of the sternotomy. At the three-month blinded photographic assessment, the scar will be graded according to width and colour. If the scar is assessed to be 1mm or less in width and the scar colour is the same as the surrounding skin, treatment will cease. If the scar is wider than 1mm and/or the scar is darker than the surrounding unaffected skin, the treatment will continue for 12 months post-operatively.

The parents will take the photographs using their camera on their smartphone. Parents will be educated by the Principal Investigator (PI) or trained Clinical Evaluators during the first photographic assessment on day of dressing removal and will be provided with photography guidelines and ongoing support via phone as required. The PI and Clinical Evaluators will all have received training from the hospital photography department before educating parents in photography.

Parents will take the 3, 6 and 12 months photographs at home and send them to the PI via password protected email or multimedia message service (MMS).

The photographs will be saved on a password protected external hard drive and taken to the medical photography department for balancing and standardising. The participants' faces will be cropped from the photographs. The photographs will be printed in the medical photography department and then graded by the blinded assessor using the inbuilt measurements in the stickers to assess width and colour.
Timepoint [1] 332997 0
Day 4-7 post-operatively, 6 months and 12 months post operatively.

Eligibility
Key inclusion criteria
- Infants less than 12 months old
- Primary sternotomy wound post cardiac surgery
- A responsible parent/guardian who has ability to take, in a required manner, photographs of the child’s sternotomy scar using his/her own smartphone and deliver the photographs back to the researchers via email or MMS (Multimedia Messaging Service).
- Parent/guardian is willing to sign the informed consent and comply with all study procedures
- At least one parent/guardian has adequate English speaking skills
Minimum age
No limit
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Overseas patients
- Patient identified by the Principal Investigator (or delegate) as having significant comorbidities or predictors of a complex surgical journey or predictors of delayed surgical closure
- Known allergy to study product contents

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Statistician generated permuted blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Within the organisation, 129 patients less than 12 months of age had a primary sternotomy in the 12 month period from July 2013 – July 2014. Our current estimate of sample size is a total of at least 200 participants; 100 in the Stratamed(Registered Trademark)/Strataderm(Registered Trademark) group and 100 in Sorbolene with Vitamin E group. A sample size of 100 patients per group has 80% power at 5% significance to detect an absolute difference of approximately 20% in a binary outcome, or a difference of 0.4 standard deviations in a normally distributed outcome. A total mean difference of 2 points (according to the scar scale) between the treatment and control group will be sufficient to meet the objective. This number of participants is feasible to recruit and process during the timeframe of the study. This information was provided by a statistician employed within the organisation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2017
Actual
Date of last participant enrolment
Anticipated
1/07/2019
Actual
Date of last data collection
Anticipated
1/07/2020
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7697 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 15620 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 295993 0
Commercial sector/Industry
Name [1] 295993 0
Stratpharma AG
Country [1] 295993 0
Switzerland
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead
Address
Cnr Hawkesbury and Hainsworth Roads
Locked Bag 4001
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 294881 0
None
Name [1] 294881 0
Address [1] 294881 0
Country [1] 294881 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297254 0
Sydney Childrens' Hospitals Network Human Research Ethics Commitee
Ethics committee address [1] 297254 0
Cnr Hawkesbury and Hainsworth Roads
Locked Bag 4001
Westmead NSW 2145
Ethics committee country [1] 297254 0
Australia
Date submitted for ethics approval [1] 297254 0
16/12/2016
Approval date [1] 297254 0
27/01/2017
Ethics approval number [1] 297254 0
HREC/15/SCHN/406

Summary
Brief summary
The aim is to confirm if Stratamed and Strataderm are effective in the prevention and treatment of abnormal scarring in infants following cardiac surgery. These products have already been approved for use in children by the Therapeutic Goods Authority (TGA). Stratamed is a medically used silicone-based scar therapy dressing in the form of a gel. Stratamed is different from other silicone gels because it can be applied to fresh wounds. This means that prevention and treatment of scarring can start much earlier. Strataderm silicone-based gel is applied on a healed wound.
A total of 200 children will be randomly allocated into two equal groups: the treatment group and the current standard treatment (control group). Allocation will occur using opaque sealed envelopes at time of surgery. Parents will be told which group their child has been randomly allocated into after the operation.
Participants in the control group will receive the standard treatment currently used in The Heart Centre for Children. A Comfeel dressing will be placed onto the wound after it has been sutured. The dressing will be removed 4-7 days post-surgery. Nothing should be applied to the wound until 2 weeks post-surgery. Parents will then start applying Sorbolene with Vitamin E cream to the scar once a day for 3 months. If at the end of 3 months there are signs that the child’s scar is healing abnormally, your child’s doctor may advise parents to continue applying the cream for up to 12 months as continuing the treatment may improve scarring overtime.
Participants in the treatment group will have Stratamed applied to the sternotomy wound directly after the wound has been sutured. A secondary dressing known as Comfeel will be placed over the Stratamed. The dressing will be removed 4-7 days post-surgery. After the dressings are removed, Strataderm will be applied to the wound. Parents will then need to apply Strataderm once a day to the wound for 3 months. If the child’s wound is not fully healed when the dressing is removed, then Stratamed will be applied twice a day until Day 14 post-surgery, at which point Strataderm can be commenced daily. If at the end of 3 months there are signs that the child’s scar is healing abnormally, then the child’s doctor may advise parents to continue applying the gel for up to 12 months as continuing the treatment may improve scarring over time.
Parents will be provided training and written instructions about how to apply the allocated scar management.
As part of the data collection for this study, photographs of the child’s wound/scar will need to be taken throughout the study period. We would like parents to take the photos on their own smartphone and send them back to the hospital via email or mobile phone MMS. The first photo will be taken after the dressing is removed, while participants are still in hospital and at this time, parents will be given a Photography Instruction Sheet and the research team will guide parents on the best methods.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73474 0
Ms Natalie Hooke
Address 73474 0
Heart Centre for Children
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 73474 0
Australia
Phone 73474 0
+61 2 9845 1133
Fax 73474 0
+61 2 9845 0556
Email 73474 0
[email protected]
Contact person for public queries
Name 73475 0
Natalie Hooke
Address 73475 0
Heart Centre for Children
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 73475 0
Australia
Phone 73475 0
+61 2 9845 1133
Fax 73475 0
+61 2 9845 0556
Email 73475 0
[email protected]
Contact person for scientific queries
Name 73476 0
Natalie Hooke
Address 73476 0
Heart Centre for Children
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 73476 0
Australia
Phone 73476 0
+61 2 9845 1133
Fax 73476 0
+61 2 9845 0556
Email 73476 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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