Clinical trial NCT03239964: Surgical Excision and Intralesional Steroid Injection for Prevention of Post Caesarean Keloid Recurrence
Official title: Combined Surgical Excision and Intralesional Steroid Injection for Prevention of Post Caesarean Keloid Recurrence.A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Keloid
Keywords: recurrent keloid
surgical excision
steroids injection
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2017-08-04
Enrollment: 146
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with recurrent lesions
timeFrame: 6 months
Secondary outcomes:
measure: Number of participantsc with pruritis
timeFrame: 6 months
measure: Number of participants with residual postinflammatory hyperpigmentation -burning sensation -wound dehiscence
timeFrame: 6 months
measure: Number of participants with burning sensation
timeFrame: 6 months
measure: Number of participants with wound dehiscence(complete)
timeFrame: 6 months
measure: Number of participants with wound dehiscence(partial)
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: KasralainiH
Study officials:
affiliation: KasrAlainiH
name: Amira Dieb, MD
role: PRINCIPAL_INVESTIGATOR
References: