Dataset Information

Efficacy of surgical excision and sub-dermal injection of triamcinolone acetonide for treatment of keloid scars after caesarean section: a single blind randomised controlled trial protocol.

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.

SUBMITTER: Chua SC

PROVIDER: S-EPMC6582563 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Publications

Efficacy of surgical excision and sub-dermal injection of triamcinolone acetonide for treatment of keloid scars after caesarean section: a single blind randomised controlled trial protocol.

Chua Seng Chai SC Gidaszewski Beata B Khajehei Marjan M

Trials 20190618 1

<h4>Background</h4>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 o ...[more]

PMID: 31215471

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Project description:BackgroundIntra-articular corticosteroids are commonly used for pain relief in patients with knee osteoarthritis. Simultaneous intra-articular corticosteroid (CS) knee injections may be beneficial for the ~80-90% of patients who present with, or develop, bilateral knee osteoarthritis, but concurrent injections may increase systemic CS exposure and data on safety/tolerability are lacking. Triamcinolone acetonide extended release (TA-ER) has shown decreased systemic triamcinolone acetonide exposure compared with traditional triamcinolone acetonide crystalline suspension (TAcs) after a single knee injection in patients with knee osteoarthritis. This phase IIa study was designed to assess the safety and systemic triamcinolone acetonide exposure following injections of TA-ER or TAcs into each knee of patients with bilateral knee osteoarthritis.MethodsPatients (⩾40 years) meeting American College of Rheumatology criteria for knee osteoarthritis in both knees received concurrent single intra-articular injections of TA-ER 32 mg or TAcs 40 mg into each knee (total: 64 mg and 80 mg, respectively) and were followed for 6 weeks. Safety was evaluated based on treatment-emergent adverse events (TEAEs). Blood samples for pharmacokinetic analysis were collected pre-injection, and at the following postinjection time points: 1, 2, 3, 4, 5, 6, 8, 10, 12, and 24 h, and days 8, 15, 29, and 43.ResultsBaseline characteristics were balanced between patients randomly assigned to TA-ER (n = 12) or TAcs (n = 12). Both treatments were well tolerated with comparable TEAE profiles. Peak plasma triamcinolone acetonide concentrations (Cmax) were lower following bilateral TA-ER injections [geometric mean, 2277.7 pg/ml (95% CI, 1602.13-3238.04)] compared with bilateral TAcs injections [7394.7 pg/ml (2201.06-24,843.43)], with median times to Cmax (Tmax) of 4.5 and 6.5 h, respectively.ConclusionsIn patients with bilateral knee osteoarthritis, intra-articular injection of TA-ER into both knees was well tolerated. Consistent with pharmacokinetic profiles observed after a single knee injection, plasma triamcinolone acetonide concentrations were lower after bilateral TA-ER injections compared with the higher and more variable concentrations observed after bilateral TAcs injections.Clinicaltrialsgov identifierNCT03378076.

Project description:Ubiquitous fungi of the Scedosporium apiospermum species complex (SASC) cause various opportunistic infections. Posterior subtenon triamcinolone acetonide (STTA) injection is a standard therapy for intraocular inflammation and macular edema. We report a case of Scedosporium apiospermum infectious scleritis after a posterior STTA injection.A 75-year-old man received a posterior STTA injection to treat macular edema in his left eye. After 3 months, he complained of ocular pain and hyperemia in his left eye. Examination showed a subtenon abscess in the site corresponding with the STTA injection. After incising the abscess, the smear revealed numerous conidia-like structures. Although we suspected fungal infection and started topical voriconazole (VRCZ) and levofloxacin, the inflammation of the eye worsened. Fungal culture revealed filamentous fungus growth. Subsequently, we added systemic VRCZ and performed surgical debridement of the infected sclera and Tenon's capsule. Pathology of the sclera showed fungal hyphae. The antifungal susceptibility test revealed low minimum inhibitory concentrations for micafungin, VRCZ and miconazole (0.06, 0.25 and 0.5 ?g/mL, respectively). After 2 months, the ciliary injection subsided and VRCZ therapy was stopped. However, subtenon abscess recurred 1 month after discontinuation of topical VRCZ. Surgical debridement and topical VRCZ were resumed, with the eye finally improving after 5 months of management. The fungal species was identified as Scedosporium apiospermum sensu stricto morphologically and by DNA sequencing.This case was successfully treated by topical and systemic VRCZ and repeated surgical debridement. Infectious scleritis caused by SASC rarely develops after posterior STTA. SASC can produce conidia in the enclosed subtenon space. Late-onset infectious scleritis after a posterior STTA injection suggests the presence of a fungal infection, including SASC, thereby requiring extensive and prolonged medical and surgical treatment.

Dataset Information

Efficacy of surgical excision and sub-dermal injection of triamcinolone acetonide for treatment of keloid scars after caesarean section: a single blind randomised controlled trial protocol.

Background

Methods/design

Discussion

Trial registration

Publications

Efficacy of surgical excision and sub-dermal injection of triamcinolone acetonide for treatment of keloid scars after caesarean section: a single blind randomised controlled trial protocol.

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