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.

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

Study Overview

• Status: Completed
• Conditions: Keloid
• Intervention / Treatment: Other: surgical excision; Drug: Dexamethasone

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.

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11956
    • KasralainiH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: excision only group; 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; total extralesional surgical excision of the keloid is performed and minimal undermining
Active Comparator: excision and injection group; 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.	Other: surgical excision; total extralesional surgical excision of the keloid is performed and minimal undermining; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital
• Investigators: Principal Investigator: Amira Dieb, MD, KasralainiH

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2016
• Primary Completion (Actual): January 24, 2018
• Study Completion (Actual): January 24, 2018

Study Registration Dates

• First Submitted: July 29, 2017
• First Submitted That Met QC Criteria: August 3, 2017
• First Posted (Actual): August 4, 2017

Study Record Updates

• Last Update Posted (Actual): November 5, 2018
• Last Update Submitted That Met QC Criteria: November 1, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: recurrent keloid; surgical excision; steroids injection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Connective Tissue Diseases; Fibrosis; Cicatrix; Collagen Diseases; Recurrence; Keloid; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 88765510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No