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Completed

NCT Number: NCT03239964

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

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

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Key information

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

KasralainiH

Cairo, 11956, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

surgical excision

Other

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

Primary outcomes

  1. Number of participants with recurrent lesions

    Time frame: 6 months

    same/smaller/larger than pretreatment lesion

Secondary outcomes

  1. Number of participantsc with pruritis

    Time frame: 6 months

    itching sensation at the site of wound

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

    Time frame: 6 months

    redness or coloured pigmentation at wound site

  3. Number of participants with burning sensation

    Time frame: 6 months

    feel burn at wound site

  4. Number of participants with wound dehiscence(complete)

    Time frame: 6 months

    area of gaping of wound that requires secondary sutures

  5. Number of participants with wound dehiscence(partial)

    Time frame: 6 months

    area of gaping of wound that requires frequent dressings only

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 4, 2017
Registry last updated
Nov 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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