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

Keloid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03239964
• Other study ID #: 88765510
• Status: Completed
• Phase: Phase 4
• Start date: August 10, 2016
• Est. completion date: January 24, 2018

Study information

• Verified date: November 2018
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: January 24, 2018
• Est. primary completion date: January 24, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Documented keloids of pfannenstiel incision or midline subumbilical incision of one to five years duration.

• Previous treatment of keloid and recurrence.

• Patient complaint of cosmetic disfiguring, pain or pruritis at site of scar.

Exclusion criteria:

• Scar <1 years' duration

• Scar extending beyond the limits of the original lesion

• postburn keloids

• Diabetes Mellitus, anaemia (haemoglobin level <10mg/dL), malignancy, malnutrition.

• local inflammation at site of scar

• Allergy to dexamethasone.

• Immunocompromized patients or patients on chronic steroid treatment.

Related Conditions & MeSH terms

• Keloid
• Recurrence

Intervention

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

Locations

Country	Name	City	State
Egypt	KasralainiH	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with recurrent lesions	same/smaller/larger than pretreatment lesion	6 months
Secondary	Number of participantsc with pruritis	itching sensation at the site of wound	6 months
Secondary	Number of participants with residual postinflammatory hyperpigmentation -burning sensation -wound dehiscence	redness or coloured pigmentation at wound site	6 months
Secondary	Number of participants with burning sensation	feel burn at wound site	6 months
Secondary	Number of participants with wound dehiscence(complete)	area of gaping of wound that requires secondary sutures	6 months
Secondary	Number of participants with wound dehiscence(partial)	area of gaping of wound that requires frequent dressings only	6 months