Efficacy of Steroid Injection for Treatment of Caesarean Section Keloid Scars
Efficacy of Sub-dermal Injection of Triamcinolone Acetonide for Treatment of Caesarean Section Keloid Scars
Westmead hospital
150 participants
May 20, 2019
Interventional
Conditions
Summary
Keloid scarring is one of the most difficult clinical problems in wound healing. It can dramatically affect a patient’s quality of life both physically and psychologically. A wide array of treatments has been used to treat keloid scars. Of these, intralesional injection of triamcinolone acetonide is most frequently used. We aim to evaluate the effectiveness of sub dermal injection of triamcinolone acetonide at the time of caesarean section to prevent keloid formation in patients with existing keloid caesarean section scar. This will be a randomized controlled clinical trial. All the patients with a previous caesarean section and presence of existing keloid scar will be included in the study. The patients will be randomized into two study groups. The control group will receive surgical excision of keloid scar then routine wound closure. The treatment group will receive surgical excision of keloid scar then sub-dermal injection of triamcinolone acetone at the time of wound closure after the delivery of the fetus. The patients are followed up for 5 days post operation for complications, then at 6 weeks, 6 months and 1 year post partum.
Eligibility
Inclusion Criteria2
- Presence of a keloid scar from a previous caesarean section
- Planed caesarean section for this current pregnancy
Exclusion Criteria2
- Primigravida
- Previous caesarean section without keloid scar
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Interventions
The intervention group will receive surgical excision of keloid scar then sub-dermal injection of triamcinolone acetone at the time of wound closure after the delivery of the fetus. The excision of the scar and administration of the injection will be performed by the surgeon that is scheduled to perform the surgery on the day. Two ampules of triamcinolone will be administered at a single dose, Each ampule contains 10mg/1ml active medication. We will inject one ampule in the upper edge of the wound and one ampule in lower edge of the wound. All the surgeons in the Department of Women's and Newborn Health will be trained on how to perform the excision and injection of the triamcinolone. The Principal Investigator of the study will assess the fidelity to the intervention by supervising procedures. The patients will be reviewed on the ward post caesarean sections for any signs of complications until discharge. The patients will be given a phone number to call to contact the investigator in case of any reaction and complication in relation to the caesarean section scar. Advice would be given to patients over the phone or invited to present to hospital for review for further management. There will be an independent data and safety monitoring committee that will be established by the head of the department of women’s and newborn health to assess at intervals the progress of the clinical trial, the safety data and the critical efficacy endpoints, and to recommend to the principal investigator whether to continue, modify or stop the clinical trial.
Locations(1)
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ACTRN12618000984291