NCT03239964

Surgical Excision and Intralesional Steroid Injection for Prevention of Post Caesarean Keloid Recurrence

Combined Surgical Excision and Intralesional Steroid Injection for Prevention of Post Caesarean Keloid Recurrence.A Randomized Controlled Trial.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Kasr El Aini Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Two groups of patients (73 patients each) undergoing routine caesarean section has recurrent keloid at site of surgical scar. One group will undergo surgical excision of keloid. The other group will have combined surgical excision of keloid and single intralesional dexamethasone injection at edges of wound.All patients were reviewed once per month for 6 months for evidence of recurrence

Detailed description

One hundred forty six patients that are admitted at Kasr Al Aini teaching university hospital for caesarean section, will be enrolled in this randomized clinical trial after approval by the local ethical health committee. A written informed consent will be obtained from each participant after full explanation of the procedure. Under general or spinal anaesthesia done routinely during caesarean section, total extralesional surgical excision of the keloid is performed and minimal undermining followed by the usual steps of caesarean section. Primary closure of the wound in layers is achieved in all cases. A running subcuticular prolene 2/0 stitch is used to suture the skin. Group A of 73 patients will not receive further injection. In 73 patients (group B), the wound edges are injected once with dexamethasone. A 1 mL syringe with a 30-gauge needle is used and injection is both intradermal and subdermal. Repeated alternate punctures are used to bathe the wound edges with the drug. Approximately 0.5-1 mL of dexamethasone (4 mg/mL) in wound tissue. For all patients, the wound is painted with betadine and sealed until postoperative day 14, at which time the subcuticular stitch is removed. Postoperative medications are given to all patients in the form of analgesics and antibiotics as routinely given at the hospital. All patients were advised to avoid direct sun exposure for the following month. No postoperative applications (eg, compression, steroid injections, etc) were used in any of the patients. All patients were reviewed once per month for 6 months.

Conditions

• Keloid

Interventions

Type	Name	Description
DRUG	Dexamethasone	the wound edges are injected once with dexamethasone. A 1 mL syringe with a 30-gauge needle is used and injection is both intradermal and subdermal. Repeated alternate punctures are used to bathe the wound edges with the drug. Approximately 0.5-1 mL of dexamethasone (4 mg/mL) in wound tissue.
OTHER	surgical excision	total extralesional surgical excision of the keloid is performed and minimal undermining

Timeline

• Start date: 2016-08-10
• Primary completion: 2018-01-24
• Completion: 2018-01-24
• First posted: 2017-08-04
• Last updated: 2018-11-05

Locations

1 site across 1 country: Egypt