Abstract
BACKGROUND: One of the first-line options to treat keloid scars is corticosteroid injection after excision of the existing scar. A thorough literature search has shown a lack of research on the injection of corticosteroid injection immediately after the excision of the existing caesarean section keloid scars. Therefore, in the proposed study, we aim to investigate the effect of surgical excision and corticosteroid (triamcinolone acetonide) injection immediately after surgical removal of old caesarean section keloid scars on the recurrence of the scars. This is a protocol for a randomised controlled trial. METHODS/DESIGN: Pregnant women (n = 150), who attend antenatal clinics at Westmead Hospital in New South Wales, Australia, have a keloid scar from a previous caesarean section, meet the inclusion criteria and sign the consent form, will be randomised to either the control or the intervention group. The control group will receive surgical excision of the keloid scar at the beginning of the procedure during skin incision. The baby will be delivered according to normal procedures, and routine wound closure will be performed in accordance with National Institute for Health and Care Excellence guidelines. The intervention group will receive surgical excision of the keloid scar after the delivery of the baby, and closure of the uterus layers, rectus sheath and the fat layer will be completed as explained above. Then, triamcinolone acetone will be injected sub-dermally at the time of wound closure. Two ampules of triamcinolone acetonide will be administered at a single dose; each ampule contains 10 mg/1 ml active medication. The surgeon will inject one ampule along the entire length of the upper edge of the skin incision and one ampule along the entire length of the lower edge of the skin incision, using a 25 G needle. After the procedure is completed, the surgeon will fill in the post-operation survey. The participants will be followed up post-operation, daily on the ward and then at 6 weeks, 6 months and 12 months post-partum. Main outcomes are (1) keloid formation after caesarean section and (2) changes in the appearance and specification of the keloid scar after the intervention. DISCUSSION: We anticipate that surgical excision and steroid injection will be a safe, lasting and cost-effective treatment in the management of caesarean keloid scars which will be useful for patients unable to undergo cosmetic surgery due to clinical or financial reasons. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12618000984291 . Registered on 12 June 2018.