Efficacy of two methods of scar care for the prevention of abnormal scarring following heart surgery in children.
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
The Children's Hospital at Westmead
200 participants
Sep 6, 2019
Interventional
Conditions
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.
Eligibility
Inclusion Criteria5
- 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
Exclusion Criteria3
- 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
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Interventions
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
Locations(1)
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ACTRN12617000813381