<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03239964</url>
  </required_header>
  <id_info>
    <org_study_id>88765510</org_study_id>
    <nct_id>NCT03239964</nct_id>
  </id_info>
  <brief_title>Surgical Excision and Intralesional Steroid Injection for Prevention of Post Caesarean Keloid Recurrence</brief_title>
  <official_title>Combined Surgical Excision and Intralesional Steroid Injection for Prevention of Post Caesarean Keloid Recurrence.A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kasr El Aini Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kasr El Aini Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Two groups of patients (73 patients each) undergoing routine caesarean section has recurrent&#xD;
      keloid at site of surgical scar. One group will undergo surgical excision of keloid. The&#xD;
      other group will have combined surgical excision of keloid and single intralesional&#xD;
      dexamethasone injection at edges of wound.All patients were reviewed once per month for 6&#xD;
      months for evidence of recurrence&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One hundred forty six patients that are admitted at Kasr Al Aini teaching university hospital&#xD;
      for caesarean section, will be enrolled in this randomized clinical trial after approval by&#xD;
      the local ethical health committee. A written informed consent will be obtained from each&#xD;
      participant after full explanation of the procedure.&#xD;
&#xD;
      Under general or spinal anaesthesia done routinely during caesarean section, total&#xD;
      extralesional surgical excision of the keloid is performed and minimal undermining followed&#xD;
      by the usual steps of caesarean section. Primary closure of the wound in layers is achieved&#xD;
      in all cases. A running subcuticular prolene 2/0 stitch is used to suture the skin. Group A&#xD;
      of 73 patients will not receive further injection. In 73 patients (group B), the wound edges&#xD;
      are injected once with dexamethasone. A 1 mL syringe with a 30-gauge needle is used and&#xD;
      injection is both intradermal and subdermal. Repeated alternate punctures are used to bathe&#xD;
      the wound edges with the drug. Approximately 0.5-1 mL of dexamethasone (4 mg/mL) in wound&#xD;
      tissue.&#xD;
&#xD;
      For all patients, the wound is painted with betadine and sealed until postoperative day 14,&#xD;
      at which time the subcuticular stitch is removed.&#xD;
&#xD;
      Postoperative medications are given to all patients in the form of analgesics and antibiotics&#xD;
      as routinely given at the hospital. All patients were advised to avoid direct sun exposure&#xD;
      for the following month. No postoperative applications (eg, compression, steroid injections,&#xD;
      etc) were used in any of the patients. All patients were reviewed once per month for 6&#xD;
      months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2016</start_date>
  <completion_date type="Actual">January 24, 2018</completion_date>
  <primary_completion_date type="Actual">January 24, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with recurrent lesions</measure>
    <time_frame>6 months</time_frame>
    <description>same/smaller/larger than pretreatment lesion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participantsc with pruritis</measure>
    <time_frame>6 months</time_frame>
    <description>itching sensation at the site of wound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with residual postinflammatory hyperpigmentation -burning sensation -wound dehiscence</measure>
    <time_frame>6 months</time_frame>
    <description>redness or coloured pigmentation at wound site</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with burning sensation</measure>
    <time_frame>6 months</time_frame>
    <description>feel burn at wound site</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with wound dehiscence(complete)</measure>
    <time_frame>6 months</time_frame>
    <description>area of gaping of wound that requires secondary sutures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with wound dehiscence(partial)</measure>
    <time_frame>6 months</time_frame>
    <description>area of gaping of wound that requires frequent dressings only</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">146</enrollment>
  <condition>Keloid</condition>
  <arm_group>
    <arm_group_label>excision only group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>excision and injection group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.&#xD;
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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>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.</description>
    <arm_group_label>excision and injection group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>surgical excision</intervention_name>
    <description>total extralesional surgical excision of the keloid is performed and minimal undermining</description>
    <arm_group_label>excision and injection group</arm_group_label>
    <arm_group_label>excision only group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented keloids of pfannenstiel incision or midline subumbilical incision of one to&#xD;
             five years duration.&#xD;
&#xD;
          -  Previous treatment of keloid and recurrence.&#xD;
&#xD;
          -  Patient complaint of cosmetic disfiguring, pain or pruritis at site of scar.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Scar &lt;1 years' duration&#xD;
&#xD;
          -  Scar extending beyond the limits of the original lesion&#xD;
&#xD;
          -  postburn keloids&#xD;
&#xD;
          -  Diabetes Mellitus, anaemia (haemoglobin level &lt;10mg/dL), malignancy, malnutrition.&#xD;
&#xD;
          -  local inflammation at site of scar&#xD;
&#xD;
          -  Allergy to dexamethasone.&#xD;
&#xD;
          -  Immunocompromized patients or patients on chronic steroid treatment.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amira Dieb, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>KasrAlainiH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KasralainiH</name>
      <address>
        <city>Cairo</city>
        <zip>11956</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>November 1, 2018</last_update_submitted>
  <last_update_submitted_qc>November 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
    <investigator_full_name>Amira S Dieb</investigator_full_name>
    <investigator_title>Amira S Dieb, MD</investigator_title>
  </responsible_party>
  <keyword>recurrent keloid</keyword>
  <keyword>surgical excision</keyword>
  <keyword>steroids injection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Keloid</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03239964
org study id: 88765510
nct id: NCT03239964
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Number of participants with recurrent lesions
time frame: 6 months
description: same/smaller/larger than pretreatment lesion
measure: Number of participantsc with pruritis
time frame: 6 months
description: itching sensation at the site of wound
measure: Number of participants with residual postinflammatory hyperpigmentation -burning sensation -wound dehiscence
time frame: 6 months
description: redness or coloured pigmentation at wound site
measure: Number of participants with burning sensation
time frame: 6 months
description: feel burn at wound site
measure: Number of participants with wound dehiscence(complete)
time frame: 6 months
description: area of gaping of wound that requires secondary sutures
measure: Number of participants with wound dehiscence(partial)
time frame: 6 months
description: area of gaping of wound that requires frequent dressings only
arm group label: excision only group
arm group type: Active Comparator
description: 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.
arm group label: excision and injection group
arm group type: Active Comparator
description: 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.
intervention type: Drug
intervention name: Dexamethasone
description: 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.
arm group label: excision and injection group
intervention type: Other
intervention name: surgical excision
description: total extralesional surgical excision of the keloid is performed and minimal undermining
arm group label: excision and injection group
arm group label: excision only group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
last name: Amira Dieb, MD
role: Principal Investigator
affiliation: KasrAlainiH
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Kasr El Aini Hospital
investigator full name: Amira S Dieb
investigator title: Amira S Dieb, MD
mesh term: Keloid
mesh term: Recurrence
mesh term: Dexamethasone
sharing ipd: No