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/NCT05961891</url>
    </required_header>
    <id_info>
      <org_study_id>Soh-Med-23-07-02MS</org_study_id>
      <nct_id>NCT05961891</nct_id>
    </id_info>
    <brief_title>The Use of Composite Bone and Nail Bed Graft Combined With Cutaneous Flaps for Reconstruction of Finger Tip Amputations</brief_title>
    <official_title>The Use of Composite Bone and Nail Bed Graft Combined With Cutaneous Flaps for Reconstruction of Finger Tip Amputations</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sohag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sohag University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Fingertip injuries are among the most common hand injuries regardless of age, as the&#xD;
        fingertip is a prominent and frequently used part of the hand. However, no consensus yet&#xD;
        exists regarding the ideal reconstruction of fingertip injuries with nail bed defects, and&#xD;
        its reconstructive methods are limited.&#xD;
  &#xD;
        Allen has classified fingertip amputations into four types. Type I injuries involve only the&#xD;
        pulp of the finger. Type II includes pulp and nail loss. Type III has partial terminal&#xD;
        phalanx loss and corresponding pulp and nail loss. Finally, type IV involves the lunule of&#xD;
        the nail, pulp, nail, and partial loss of the terminal phalanx.&#xD;
  &#xD;
        Fingertip amputations through the proximal half of the nail-bed are challenging as the&#xD;
        remaining nail-bed has inadequate length for satisfactory nail growth. Replantation at this&#xD;
        level gives a good functional and cosmetic results but is technically demanding, requires&#xD;
        microsurgical skills and adequate facilities and is not always possible.When replantation is&#xD;
        not possible, the use of a local advancement palmar flap preserves digital length and the&#xD;
        remaining nail bed.&#xD;
  &#xD;
        However, when the amputation is through the proximal third of the nail, this technique leaves&#xD;
        very little nail bed and nail deformities are common.To avoid these deformities, complete&#xD;
        ablation of the nail bed and germinal matrix with closure by a palmar advancement flap, or by&#xD;
        shortening, are usually carried out. Unfortunately, these treatments often fail to satisfy&#xD;
        the patient's desire to retain his or her nail.&#xD;
  &#xD;
        When replantation is not feasible, the technique of advancing a palmar V-Y flap and applying&#xD;
        the nail bed retrieved from the amputated part to the dorsum of the flap provides an&#xD;
        alternative means of restoring nail bed length. So the technique of using composite bone and&#xD;
        nail bed graft from the amputated part with a local or regional cutaneous flaps may be an&#xD;
        option for treatment of fresh fingertip amputation to restore the shape and preserve the&#xD;
        length of the fingertip especially in circumstances when microsurgical replantation is not&#xD;
        feasible.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 10, 2023</start_date>
    <completion_date type="Anticipated">June 10, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 10, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Fingertip length</measure>
      <time_frame>1 year</time_frame>
      <description>Fingertip length is estimated in Centimeters</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Finger Tip Amputations</condition>
    <arm_group>
      <arm_group_label>Patients with Finger Tip Amputations</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with Finger Tip Amputations</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>The Use of Composite Bone and Nail Bed Graft Combined With Cutaneous Flaps for Reconstruction of Finger Tip Amputations</intervention_name>
      <description>The amputated finger tip is cleaned and a composite graft including the nail bed and bone of distal phalanx is taken from the amputated part.&#xD;
  The bone of the amputated part is fixed to the remaining stump of the distal phalanx with an axial 21gauge needle or by a K-wire (0.8 mm).&#xD;
  The nail bed graft is sutured with 6-0 vicryl to the remaining nail bed.&#xD;
  A local or regional cutaneous flap is used to cover the volar aspect and tip of the distal phalanx bone e.g. V-Y advancement flap, thenar flap or cross finger flap .The flap should protrude beyond the tip, providing extra skin which is recontoured to a rounded tip.&#xD;
  The nail plate is inserted in the nail fold to prevent the formation of synechiae between the nail fold and the injured nail bed.&#xD;
  The finger is immobilized for two weeks in a below elbow dorsal slab.&#xD;
  Patients are followed up for 3 months. Postoperative complications and their management will be recorded.</description>
      <arm_group_label>Patients with Finger Tip Amputations</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Any level of finger tip amputations through the nail bed and distal phalanx with&#xD;
               preserved amputated part.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Crushed part of amputated segment.&#xD;
  &#xD;
            -  Patients with peripheral vascular disease.&#xD;
  &#xD;
            -  Diabetic patient.&#xD;
  &#xD;
            -  Pateint over 65 or under 5 years of age.&#xD;
  &#xD;
            -  Patient refusal.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Hassan H Hamed, resident</last_name>
      <phone>01158742230</phone>
      <email>hassanhamed@med.sohag.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>SaMIA Ahmed, professor</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sohag university Hospital</name>
        <address>
          <city>Sohag</city>
          <zip>Sohag</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Magdy M Amin, professor</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Allen MJ. Conservative management of finger tip injuries in adults. Hand. 1980 Oct;12(3):257-65. doi: 10.1016/s0072-968x(80)80049-0.</citation>
      <PMID>7002744</PMID>
    </reference>
    <reference>
      <citation>Brown RE, Zook EG, Russell RC. Fingertip reconstruction with flaps and nail bed grafts. J Hand Surg Am. 1999 Mar;24(2):345-51. doi: 10.1053/jhsu.1999.0345.</citation>
      <PMID>10194021</PMID>
    </reference>
    <reference>
      <citation>Celik N, Wei FC, Lin CH, Cheng MH, Chen HC, Jeng SF, Kuo YR. Technique and strategy in anterolateral thigh perforator flap surgery, based on an analysis of 15 complete and partial failures in 439 cases. Plast Reconstr Surg. 2002 Jun;109(7):2211-6; discussion 2217-8. doi: 10.1097/00006534-200206000-00005.</citation>
      <PMID>12045538</PMID>
    </reference>
    <reference>
      <citation>Cheung K, Hatchell A, Thoma A. Approach to traumatic hand injuries for primary care physicians. Can Fam Physician. 2013 Jun;59(6):614-8.</citation>
      <PMID>23766041</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 17, 2023</last_update_submitted>
    <last_update_submitted_qc>July 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sohag University</investigator_affiliation>
      <investigator_full_name>Hassan Abdellatif Hamed</investigator_full_name>
      <investigator_title>Resident-plastic department-sohag hospital university</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05961891
  org study id: Soh-Med-23-07-02MS
  nct id: NCT05961891
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Fingertip injuries are among the most common hand injuries regardless of age, as the
        fingertip is a prominent and frequently used part of the hand. However, no consensus yet
        exists regarding the ideal reconstruction of fingertip injuries with nail bed defects, and
        its reconstructive methods are limited.
  
        Allen has classified fingertip amputations into four types. Type I injuries involve only the
        pulp of the finger. Type II includes pulp and nail loss. Type III has partial terminal
        phalanx loss and corresponding pulp and nail loss. Finally, type IV involves the lunule of
        the nail, pulp, nail, and partial loss of the terminal phalanx.
  
        Fingertip amputations through the proximal half of the nail-bed are challenging as the
        remaining nail-bed has inadequate length for satisfactory nail growth. Replantation at this
        level gives a good functional and cosmetic results but is technically demanding, requires
        microsurgical skills and adequate facilities and is not always possible.When replantation is
        not possible, the use of a local advancement palmar flap preserves digital length and the
        remaining nail bed.
  
        However, when the amputation is through the proximal third of the nail, this technique leaves
        very little nail bed and nail deformities are common.To avoid these deformities, complete
        ablation of the nail bed and germinal matrix with closure by a palmar advancement flap, or by
        shortening, are usually carried out. Unfortunately, these treatments often fail to satisfy
        the patient's desire to retain his or her nail.
  
        When replantation is not feasible, the technique of advancing a palmar V-Y flap and applying
        the nail bed retrieved from the amputated part to the dorsum of the flap provides an
        alternative means of restoring nail bed length. So the technique of using composite bone and
        nail bed graft from the amputated part with a local or regional cutaneous flaps may be an
        option for treatment of fresh fingertip amputation to restore the shape and preserve the
        length of the fingertip especially in circumstances when microsurgical replantation is not
        feasible.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Fingertip length
  time frame: 1 year
  description: Fingertip length is estimated in Centimeters
  arm group label: Patients with Finger Tip Amputations
  arm group type: Experimental
  description: Patients with Finger Tip Amputations
  intervention type: Procedure
  intervention name: The Use of Composite Bone and Nail Bed Graft Combined With Cutaneous Flaps for Reconstruction of Finger Tip Amputations
  description: The amputated finger tip is cleaned and a composite graft including the nail bed and bone of distal phalanx is taken from the amputated part.
  The bone of the amputated part is fixed to the remaining stump of the distal phalanx with an axial 21gauge needle or by a K-wire (0.8 mm).
  The nail bed graft is sutured with 6-0 vicryl to the remaining nail bed.
  A local or regional cutaneous flap is used to cover the volar aspect and tip of the distal phalanx bone e.g. V-Y advancement flap, thenar flap or cross finger flap .The flap should protrude beyond the tip, providing extra skin which is recontoured to a rounded tip.
  The nail plate is inserted in the nail fold to prevent the formation of synechiae between the nail fold and the injured nail bed.
  The finger is immobilized for two weeks in a below elbow dorsal slab.
  Patients are followed up for 3 months. Postoperative complications and their management will be recorded.
  arm group label: Patients with Finger Tip Amputations
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Hassan H Hamed, resident
  phone: 01158742230
  email: hassanhamed@med.sohag.edu.eg
  last name: SaMIA Ahmed, professor
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  citation: Allen MJ. Conservative management of finger tip injuries in adults. Hand. 1980 Oct;12(3):257-65. doi: 10.1016/s0072-968x(80)80049-0.
  PMID: 7002744
  citation: Brown RE, Zook EG, Russell RC. Fingertip reconstruction with flaps and nail bed grafts. J Hand Surg Am. 1999 Mar;24(2):345-51. doi: 10.1053/jhsu.1999.0345.
  PMID: 10194021
  citation: Celik N, Wei FC, Lin CH, Cheng MH, Chen HC, Jeng SF, Kuo YR. Technique and strategy in anterolateral thigh perforator flap surgery, based on an analysis of 15 complete and partial failures in 439 cases. Plast Reconstr Surg. 2002 Jun;109(7):2211-6; discussion 2217-8. doi: 10.1097/00006534-200206000-00005.
  PMID: 12045538
  citation: Cheung K, Hatchell A, Thoma A. Approach to traumatic hand injuries for primary care physicians. Can Fam Physician. 2013 Jun;59(6):614-8.
  PMID: 23766041
  responsible party type: Principal Investigator
  investigator affiliation: Sohag University
  investigator full name: Hassan Abdellatif Hamed
  investigator title: Resident-plastic department-sohag hospital university
  sharing ipd: Undecided