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

NCT03239964 | Completed Phase 4

• 1 other identifier: 88765510
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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

Conditions

Keloid

Keywords

recurrent keloid; surgical excision; steroids injection

Outcome Measures

Primary Outcomes (1)

• Number of participants with recurrent lesions

  same/smaller/larger than pretreatment lesion

  6 months

Secondary Outcomes (5)

• Number of participantsc with pruritis

  6 months

• Number of participants with residual postinflammatory hyperpigmentation -burning sensation -wound dehiscence

  6 months

• Number of participants with burning sensation

  6 months

• Number of participants with wound dehiscence(complete)

  6 months

• Number of participants with wound dehiscence(partial)

  6 months

Study Arms (2)

excision only group

ACTIVE COMPARATOR

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

excision and injection group

ACTIVE COMPARATOR

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; Other: surgical excision

Interventions

Dexamethasone DRUG

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.

excision and injection group

surgical excision OTHER

total extralesional surgical excision of the keloid is performed and minimal undermining

excision and injection group; excision only group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

KasralainiH

Cairo, 11956, Egypt

Location

MeSH Terms

Conditions

Keloid

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Amira Dieb, MD

  KasrAlainiH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Amira S Dieb, MD

Study Record Dates

• First Submitted: July 29, 2017
• First Posted: August 4, 2017
• Study Start: August 10, 2016
• Primary Completion: January 24, 2018
• Study Completion: January 24, 2018
• Last Updated: November 5, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)