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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Keloid

Intervention / Treatment
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* Drug: Dexamethasone
* Other: surgical excision


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: excision only group<br>Under general or spinal anaesthesia done routinely during caesarean section, total extralesional surgical excision of keloid is performed and minimal undermining followed by usual steps of caesarean section. Primary closure of 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. The wound is painted with betadine and sealed until postoperative day 14, at which time the subcuticular stitch is removed. Routine postoperative medications are given to all patients. They are advised to avoid direct sun exposure for the following month. No postoperative applications (eg, compression, steroid injections, etc) are used in any of the patients. All patients are reviewed once per month for 6 months. | Other: surgical excision<br>* total extralesional surgical excision of the keloid is performed and minimal undermining<br>|
| Active Comparator: excision and injection group<br>Under general or spinal anaesthesia done routinely during caesarean section, total extralesional surgical excision of keloid is performed and minimal undermining followed by usual steps of caesarean section and primary closure of the wound in layers. A running subcuticular prolene 2/0 stitch is used to suture skin.In 73 patients (group B), wound edges are injected once with dexamethasone. A 1 mL syringe with a 30-gauge needle is used 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. The wound is painted with betadine and sealed until postoperative day 14 to remove the subcuticular stitch. Routine postoperative medications are given, avoidance of direct sun exposure for one month,No postoperative applications as compression, steroid injections, etc. All patients are reviewed once per month for 6 months. | Drug: Dexamethasone<br>* 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.<br>Other: surgical excision<br>* total extralesional surgical excision of the keloid is performed and minimal undermining<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with recurrent lesions | same/smaller/larger than pretreatment lesion | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participantsc with pruritis | itching sensation at the site of wound | 6 months | 
| Number of participants with residual postinflammatory hyperpigmentation -burning sensation -wound dehiscence | redness or coloured pigmentation at wound site | 6 months | 
| Number of participants with burning sensation | feel burn at wound site | 6 months | 
| Number of participants with wound dehiscence(complete) | area of gaping of wound that requires secondary sutures | 6 months | 
| Number of participants with wound dehiscence(partial) | area of gaping of wound that requires frequent dressings only | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent keloid, surgical excision, steroids injection