xml: <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/NCT05984862</url>
    </required_header>
    <id_info>
      <org_study_id>PMDC-23-07-6745</org_study_id>
      <nct_id>NCT05984862</nct_id>
    </id_info>
    <brief_title>Role of Bandage After FUE Hair Transplantation</brief_title>
    <official_title>Bandage Versus No-Bandage After Follicular Unit Extraction Hair Transplantation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pak Medical and Diagnostic Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Pak Medical and Diagnostic Center</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>
        The aim of this interventional study is to determine the role of bandage on the follicular&#xD;
        donor sites on the scalp after FUE hair transplantation.&#xD;
  &#xD;
        A randomized side of the scalp will be covered using bandage, the other side will be left&#xD;
        naked. Subjects under study will be evaluated after the procedure is completed, and day 1 and&#xD;
        day 7 post-procedure during the healing phase. This will in turn help, answering the&#xD;
        importance of bandage in healing of the donor site post-hair transplantation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this modern era, hair-transplantation has become very common. Interests in wound healing&#xD;
        is not new; with every passing day, different techniques are introduced to get better results&#xD;
        for the patients. The current literature available online shows that many hair-transplant&#xD;
        centers have stated about using bandage on the donor area post-transplantation, however,&#xD;
        there isn't a single study available to augment this use of bandage. On the other hand, data&#xD;
        regarding application of antibiotic ointments and silicon gels is available. The punctures&#xD;
        made during FUE are only of 9-10mm, requiring no sutures. In addition to this, the blood&#xD;
        supply of the scalp also favors quick healing. The process of re-epithelization starts within&#xD;
        a few hours of injury and progresses over the first 1 to 3 days. Most of the clinics remove,&#xD;
        the bandage after 24hrs, disrupting the healing process of the skin. In the present study,&#xD;
        the investigators sought to compare bandage versus no-Bandage donor site in terms of healing.&#xD;
        The investigators hypothesize that, compared with bandage site, no-bandage donor site after&#xD;
        FUE will have reduce post-procedural downtime and donor site inflammation ultimately,&#xD;
        enhancing patient satisfaction with the procedure. The long-term goal of this study is to get&#xD;
        evidence-based usage of bandage, if results are in contrast with the hypothesis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <intervention_model_description>This is a single center, triple-blind, within subject split scalp study investigating the comparison of bandage versus no bandage donor site post FUE. Twenty-five subjects desiring to undergo FUE for hair restoration will have bandage on one half of the donor area on the back of the scalp and no-bandage on the other side for 24 hours post procedure. The sides of the scalp will be randomized, and the evaluating physician will be blinded. Subjects will be evaluated, photographed, and will fill out subject reported questionnaires live at days 1 (+1) and 7 (±1) post procedure.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>This is a randomized, triple-blind, split-scalp study. The subjects will know what side of the scalp the bandage products are applied. However, during evaluation, the subjects and analyst will be shown close-up pictures of the two sides without exposing the patient's identity and actual sides.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Wound healing change over time from day 0 to day +1 (+1), to day +7 (±1)</measure>
      <time_frame>duration of the study be evaluated and rated on days 1 (+1) and 7 (±1) post procedure for both the bandage and no bandage sites</time_frame>
      <description>Bandage has protection role to some extent; however, removal of bandage will affect the normal healing of donor site. Healing Response (4-point ordinal scale) LEFT SIDE&#xD;
  Not healed at all (0%)&#xD;
  Mildly healed (33%)&#xD;
  Moderately healed (66%)&#xD;
  Completely healed (100%)&#xD;
  RIGHT SIDE&#xD;
  Not healed at all (0%)&#xD;
  Mild healing (33%)&#xD;
  Moderately healed (66%)&#xD;
  Completely healed (100%)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Hair Loss/Baldness</condition>
    <arm_group>
      <arm_group_label>Experimental: Treatment left</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A randomized side of the scalp will be covered with bandage, the other side with no bandage.&#xD;
  Intervention: Device: Treatment - Bandage</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental: Treatment right</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A randomized side of the scalp will be covered with bandage, the other side with no bandage.&#xD;
  Intervention: Device: Treatment - Bandage</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Bandage</intervention_name>
      <description>To determine if using bandage versus no-bandage, plays a role in limiting severity and duration of signs and symptoms of acute inflammation post follicular harvesting procedure</description>
      <arm_group_label>Experimental: Treatment left</arm_group_label>
      <arm_group_label>Experimental: Treatment right</arm_group_label>
      <other_name>wound healing</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Over 18 years old&#xD;
  &#xD;
            -  Able to provide informed consent&#xD;
  &#xD;
            -  Planning to undergo follicular unit extraction hair restoration&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Significant medical or surgical conditions&#xD;
  &#xD;
            -  Unable to give informed consent&#xD;
  &#xD;
            -  Immunocompromised&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Muhammad Sarfraz Khan, BSc, MBBS</last_name>
      <role>Study Director</role>
      <affiliation>Pak Medical and Diagnostic Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jawad Jahangir, MBBS, FCPS,ABHRS</last_name>
      <phone>+923205636745</phone>
      <email>j.jabbasi@hotmail.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Pak Medical and Diagnostic Center</investigator_affiliation>
      <investigator_full_name>Muhammad Sarfraz Khan</investigator_full_name>
      <investigator_title>Research Associate</investigator_title>
    </responsible_party>
    <keyword>Hair Loss</keyword>
    <keyword>Follicular Unit Extraction</keyword>
    <keyword>Hair transplantation</keyword>
    <keyword>Wound healing</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alopecia</mesh_term>
      <mesh_term>Alopecia Areata</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05984862
  org study id: PMDC-23-07-6745
  nct id: NCT05984862
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this interventional study is to determine the role of bandage on the follicular
        donor sites on the scalp after FUE hair transplantation.
  
        A randomized side of the scalp will be covered using bandage, the other side will be left
        naked. Subjects under study will be evaluated after the procedure is completed, and day 1 and
        day 7 post-procedure during the healing phase. This will in turn help, answering the
        importance of bandage in healing of the donor site post-hair transplantation.
  In this modern era, hair-transplantation has become very common. Interests in wound healing
        is not new; with every passing day, different techniques are introduced to get better results
        for the patients. The current literature available online shows that many hair-transplant
        centers have stated about using bandage on the donor area post-transplantation, however,
        there isn't a single study available to augment this use of bandage. On the other hand, data
        regarding application of antibiotic ointments and silicon gels is available. The punctures
        made during FUE are only of 9-10mm, requiring no sutures. In addition to this, the blood
        supply of the scalp also favors quick healing. The process of re-epithelization starts within
        a few hours of injury and progresses over the first 1 to 3 days. Most of the clinics remove,
        the bandage after 24hrs, disrupting the healing process of the skin. In the present study,
        the investigators sought to compare bandage versus no-Bandage donor site in terms of healing.
        The investigators hypothesize that, compared with bandage site, no-bandage donor site after
        FUE will have reduce post-procedural downtime and donor site inflammation ultimately,
        enhancing patient satisfaction with the procedure. The long-term goal of this study is to get
        evidence-based usage of bandage, if results are in contrast with the hypothesis.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: This is a single center, triple-blind, within subject split scalp study investigating the comparison of bandage versus no bandage donor site post FUE. Twenty-five subjects desiring to undergo FUE for hair restoration will have bandage on one half of the donor area on the back of the scalp and no-bandage on the other side for 24 hours post procedure. The sides of the scalp will be randomized, and the evaluating physician will be blinded. Subjects will be evaluated, photographed, and will fill out subject reported questionnaires live at days 1 (+1) and 7 (±1) post procedure.
  primary purpose: Treatment
  masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  masking description: This is a randomized, triple-blind, split-scalp study. The subjects will know what side of the scalp the bandage products are applied. However, during evaluation, the subjects and analyst will be shown close-up pictures of the two sides without exposing the patient's identity and actual sides.
  measure: Wound healing change over time from day 0 to day +1 (+1), to day +7 (±1)
  time frame: duration of the study be evaluated and rated on days 1 (+1) and 7 (±1) post procedure for both the bandage and no bandage sites
  description: Bandage has protection role to some extent; however, removal of bandage will affect the normal healing of donor site. Healing Response (4-point ordinal scale) LEFT SIDE
  Not healed at all (0%)
  Mildly healed (33%)
  Moderately healed (66%)
  Completely healed (100%)
  RIGHT SIDE
  Not healed at all (0%)
  Mild healing (33%)
  Moderately healed (66%)
  Completely healed (100%)
  arm group label: Experimental: Treatment left
  arm group type: Experimental
  description: A randomized side of the scalp will be covered with bandage, the other side with no bandage.
  Intervention: Device: Treatment - Bandage
  arm group label: Experimental: Treatment right
  arm group type: Experimental
  description: A randomized side of the scalp will be covered with bandage, the other side with no bandage.
  Intervention: Device: Treatment - Bandage
  intervention type: Device
  intervention name: Bandage
  description: To determine if using bandage versus no-bandage, plays a role in limiting severity and duration of signs and symptoms of acute inflammation post follicular harvesting procedure
  arm group label: Experimental: Treatment left
  arm group label: Experimental: Treatment right
  other name: wound healing
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Muhammad Sarfraz Khan, BSc, MBBS
  role: Study Director
  affiliation: Pak Medical and Diagnostic Center
  last name: Jawad Jahangir, MBBS, FCPS,ABHRS
  phone: +923205636745
  email: j.jabbasi@hotmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Pak Medical and Diagnostic Center
  investigator full name: Muhammad Sarfraz Khan
  investigator title: Research Associate
  mesh term: Alopecia
  mesh term: Alopecia Areata
  sharing ipd: No