<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/NCT03757572</url>
  </required_header>
  <id_info>
    <org_study_id>Pilonidal QoL</org_study_id>
    <nct_id>NCT03757572</nct_id>
  </id_info>
  <brief_title>Alginate Dressings Versus Gauge Dressings After Pilonidal Cyst Resection: Examination of the Quality of Life</brief_title>
  <official_title>Secondary Intention Wound Healing, in Patients Subjected to Surgical Resection of Pilonidal Cyst, Using Alginate Dressings With Silver and High-G Cellulose, Compared to the Use of Simple Gauze Dressings: Examination of the Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Larissa University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Thessaly</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Larissa University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to compare the application of alginate dressings with silver and&#xD;
      high-G cellulose and the use of simple gauge dressings in patients submitted to surgical&#xD;
      resection of pilonidal cyst. The present trial will focus on the postoperative quality of&#xD;
      life during the secondary intention wound healing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pilonidal cyst was first described by Hodges in 1880. The disease of pilonidal cyst is also&#xD;
      known as &quot;Jeep disease&quot;, due to the fact that, during World War II (1941-1945), several&#xD;
      American soldiers (about 80,000) suffered from this disease, because, either they were&#xD;
      driving for long hours on uneven, destroyed by war, roads, or, they were spending time&#xD;
      sitting at military vehicles like jeep, trucks and tankers, resulting in being submitted to&#xD;
      surgical operation, in order to alleviate the arousing pilonidal cyst problem, at USA&#xD;
      military hospitals.&#xD;
&#xD;
      Pilonidal cyst, is considered as one of the most common diseases of the subcutaneous tissues&#xD;
      of the sacrococcygeal region. This situation is the result of hair penetrating into the skin,&#xD;
      a situation not uncommon in this anatomical area. In a study including 50,000 college&#xD;
      students, pilonidal cyst occurrence, in males, was 1.1%, which was 10 times higher compared&#xD;
      to females, although a considerable rate of them was asymptomatic. Evidence from studies in&#xD;
      England, also, indicate that the disease is more frequent in men than women (1 to 3) . The&#xD;
      disease is more common in Caucasians than in Asians or Africans due to the differences in&#xD;
      their hair characteristics and the respective hair development pattern. Risk factors include&#xD;
      the following: sedentary life (44%), positive family history (38%), obesity (50%) and&#xD;
      regional irritation (34%). The disease usually presents during the age of 16 - 20 and&#xD;
      prevalence is decreasing drastically after the 25th year of age. This disease rarely develops&#xD;
      before the adolescence and after the 40th year of age.&#xD;
&#xD;
      Treatment usually depends on the condition of the disease. An acute abscess is usually&#xD;
      controlled with incision and drainage. A chronic pilonidal cyst is best treated with a&#xD;
      surgical procedure that involves complete resection of the cyst along with the coexisting&#xD;
      fistulas, in order to ensure the minimum reoccurrence rate. There are two choices after&#xD;
      surgical resection, secondary intention wound healing or primary trauma closure, with or&#xD;
      without a flap. The surgical procedure can be performed with the administration of local&#xD;
      anaesthesia in the outpatient office or in a day-clinic, or with the use of general&#xD;
      anaesthesia depending on the condition of the patient.&#xD;
&#xD;
      Post operatively secondary intention wound healing is applied in many cases, especially when&#xD;
      factors like infection, necrotic tissue or inflammatory tissue are introduced. There are many&#xD;
      dressings that can be used for the care of a surgical trauma. The ideal dressing used should&#xD;
      have some special characteristics such as absorption of exudates without leakage, provision&#xD;
      of a dry environment that prevents bacteria from entering the wound and facilitation of easy&#xD;
      appliance, as well as removal. Choosing the right dressing is not based on a certain&#xD;
      protocol, but mostly on the surgeon preference.&#xD;
&#xD;
      The current study aims at comparing two groups of patients that will be subjected to surgical&#xD;
      resection of pilonidal cyst and secondary intention wound healing. In the first group,&#xD;
      dressings like alginate cord with silver and high G cellulose will be used for filling of the&#xD;
      wound cavity and a hydro-capillary dressing for sealing and waterproofing the wound. In the&#xD;
      other group, simple gauze dressings for the coverage of the wound cavity will be used.&#xD;
      Comparison of the two groups will involve all the endpoints that indicate whether such&#xD;
      dressings can facilitate faster wound healing, enabling, thus, patients to faster return to&#xD;
      their everyday activities. Furthermore, a parameter that has not been, previously, studied,&#xD;
      the quality of life after the surgical excision of the pilonidal cyst, by using the SF - 36&#xD;
      and the Quality of life with Chronic Wound questionnaire, will, also, be investigated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Early termination due to COVID-19 pandemic. Suspension of elective case operations. Decreased&#xD;
    recruitment rate. Inability to reach the estimated sample size.&#xD;
  </why_stopped>
  <start_date type="Actual">December 25, 2018</start_date>
  <completion_date type="Actual">April 25, 2021</completion_date>
  <primary_completion_date type="Actual">February 25, 2021</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Blinding will exist at the level of the investigator who will record the data postoperatively. There will be no blinding at the level of the surgeon or the patient.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Wound healing time</measure>
    <time_frame>Maximum time frame 50 days postoperatively</time_frame>
    <description>Postoperative required time for wound healing. Measurement unit: days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative return to everyday activities</measure>
    <time_frame>Maximum time frame 50 days postoperatively</time_frame>
    <description>Time required for returning to everyday activities. Measurement unit: days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain level</measure>
    <time_frame>7, 14, 21, 28, 35, 42 and 49 days postoperatively</time_frame>
    <description>Pain level after surgery, quantified with the use of the Visual Analogue Scale (0-10). Better outcome: 0, Worse outcome: 10. There will be no subscales or total scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative analgesics consumption</measure>
    <time_frame>7, 14, 21, 28, 35, 42 and 49 days postoperatively</time_frame>
    <description>Number of analgesic pills consumed per day after surgery. Measurement unit: pills per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall satisfaction level</measure>
    <time_frame>50 days postoperatively</time_frame>
    <description>Satisfaction level after surgery, quantified with the use of the Visual Analogue Scale (0-10). Better outcome: 10, Worse outcome: 0. There will be no subscales or total scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of the material</measure>
    <time_frame>Maximum time frame 50 days postoperatively</time_frame>
    <description>Overall cost of the dressings applied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound care visits</measure>
    <time_frame>7, 14, 21, 28, 35, 42 and 49 days postoperatively</time_frame>
    <description>Number of required visits for postoperative wound care for each patient per week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trauma secretions</measure>
    <time_frame>7, 14, 21, 28, 35, 42 and 49 days postoperatively</time_frame>
    <description>Trauma secretions leading to extra dressing care. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound contamination</measure>
    <time_frame>Maximum time frame 50 days postoperatively</time_frame>
    <description>Contamination of the wound trauma. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound erythema</measure>
    <time_frame>Maximum time frame 50 days postoperatively</time_frame>
    <description>Erythema of the wound. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound haematoma</measure>
    <time_frame>Maximum time frame 50 days postoperatively</time_frame>
    <description>Haematoma of the wound. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease recurrence</measure>
    <time_frame>Maximum time frame 1 year postoperatively</time_frame>
    <description>Disease recurrence rate. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the quality of life of the patient</measure>
    <time_frame>7, 14 and 21 days potoperatively</time_frame>
    <description>Difference in the quality of life of the patient based on the Quality of Life with Chronic Wounds Wounds (Qol) Questionnaire. 17 items in total. Each item quantified with the use of a Visual Ordinal Scale (0='not at all' to 4='very much'). Global score computed by averaging all items. In total 3 subscales calculated by averaging the respective items:&#xD;
Body: Items #1 to #5. Psyche: Items #6 to #10. Everyday life: Items #11 to #16.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medium term quality of life</measure>
    <time_frame>28 days postoperatively</time_frame>
    <description>Quality of life of the patient based on the Short Form 36 (SF-36) questionnaire. 36 items in total. The following ordinal scales will be used for the respective items:&#xD;
1 (Better)-5 (Worse): #1, #2, #20, #22, #34, #36.&#xD;
1 (Worse)-3 (Better): #3, to #12.&#xD;
1 (Worse)-2 (Better): #13, to #19.&#xD;
1 (Better)-6 (Worse): #21, #23, #26, #27, #30.&#xD;
1 (Worse)-6 (Better): #24, #25, #28, #29, #31.&#xD;
1 (Worse)-5 (Better): #32, #33, #35. In total 8 subscales calculated by averaging the respective items. Physical functioning: #3 to #12. Role limitations due to physical health: #13 to #16. Role limitations due to emotional problems: #17 to #19. Energy/fatigue: #23, #27, #29, #31. Emotional well-being: #24 to #26, #28, #30. Social functioning: #20, #32. Pain: #21, #22. General health: #1, #33 to #36.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment satisfaction</measure>
    <time_frame>35 days postoperatively</time_frame>
    <description>Patient satisfaction regarding the treatment quantified with the use of a Visual Ordinal Scale (1-5). Better outcome: 5, Worse outcome: 1. There will be no subscales or total scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment acceptance</measure>
    <time_frame>35 days postoperatively</time_frame>
    <description>Patient acceptance regarding the re-application of the treatment quantified with the use of a Visual Ordinal Scale (1-5). Better outcome: 5, Worse outcome: 1. There will be no subscales or total scores.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Pilonidal Cyst/Fistula</condition>
  <arm_group>
    <arm_group_label>Alginate dressings</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The pilonidal cyst will be resected, with the use of a scalpel and then haemostasis will be performed with diathermy.&#xD;
Alginate dressings with silver and high-G cellulose, which combine increased absorption properties, antimicrobial action and high coherence will be used. The size of the dressings will be 3cm X 45cm and 1 cm cord will be used for filling the wound cavity. Dressings with perimetric adhesive layer from natural materials for latent breathing of the skin with dressing dimensions based on the wound size, will be also placed.&#xD;
Wound care will be performed in a specific way each time that the dressings will be removed. The wound will be irrigated with normal saline and betadine solution and finally without pressure the trauma will be dried.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Simple gauze dressings</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The pilonidal cyst will be resected, with the use of a scalpel and then haemostasis will be performed with diathermy.&#xD;
Wound care will be performed with the application of simple gauze dressings. Wound care will be performed in a specific way each time that the dressings will be removed. The wound will be irrigated with normal saline and betadine solution and finally without pressure the trauma will be dried.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Alginate dressings</intervention_name>
    <description>The pilonidal cyst will be resected, with the use of a scalpel and then haemostasis will be performed with diathermy. Alginate dressings with silver and high-G cellulose will be applied to the wound. The size of the dressings will be 3cm X 45cm and 1 cm cord will be used for filling the wound cavity. Dressings with perimetric adhesive layer from natural materials, will be also placed.&#xD;
During wound care the wound will be irrigated with normal saline and betadine solution and finally without pressure the trauma will be dried.</description>
    <arm_group_label>Alginate dressings</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Simple gauze dressings</intervention_name>
    <description>The pilonidal cyst will be resected, with the use of a scalpel and then haemostasis will be performed with diathermy. Simple gauze dressings will be applied to the wound.&#xD;
During wound care the wound will be irrigated with normal saline and betadine solution and finally without pressure the trauma will be dried.</description>
    <arm_group_label>Simple gauze dressings</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Pilonidal cyst&#xD;
&#xD;
          -  Age: 18 to 80 years&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) score: I, II, III, IV&#xD;
&#xD;
          -  Disease stage I,II,III and IV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pilonidal abscess&#xD;
&#xD;
          -  Patient age ≥ 80 years or &lt; 18 years&#xD;
&#xD;
          -  Pilonidal abscess&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ioannis Mamaloudis</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Surgery, University Hospital of Larissa</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Konstantinos Tepetes</last_name>
    <role>Study Director</role>
    <affiliation>Department of Surgery, University Hospital of Larissa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Larissa</name>
      <address>
        <city>Larissa</city>
        <zip>41110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <reference>
    <citation>DWIGHT RW, MALOY JK. Pilonidal sinus; experience with 449 cases. N Engl J Med. 1953 Dec 3;249(23):926-30. doi: 10.1056/NEJM195312032492303. No abstract available.</citation>
    <PMID>13111384</PMID>
  </reference>
  <reference>
    <citation>BUIE LA, CURTISS RK. Pilonidal disease. Surg Clin North Am. 1952 Aug:1247-59. No abstract available.</citation>
    <PMID>14950701</PMID>
  </reference>
  <reference>
    <citation>Berry DP. Pilonidal sinus disease. J Wound Care. 1992 Sep 2;1(3):29-32. doi: 10.12968/jowc.1992.1.3.29.</citation>
    <PMID>27911182</PMID>
  </reference>
  <reference>
    <citation>Sondenaa K, Andersen E, Nesvik I, Soreide JA. Patient characteristics and symptoms in chronic pilonidal sinus disease. Int J Colorectal Dis. 1995;10(1):39-42. doi: 10.1007/BF00337585.</citation>
    <PMID>7745322</PMID>
  </reference>
  <reference>
    <citation>Kronborg O, Christensen K, Zimmermann-Nielsen C. Chronic pilonidal disease: a randomized trial with a complete 3-year follow-up. Br J Surg. 1985 Apr;72(4):303-4. doi: 10.1002/bjs.1800720418.</citation>
    <PMID>3886069</PMID>
  </reference>
  <reference>
    <citation>Sondenaa K, Diab R, Nesvik I, Gullaksen FP, Kristiansen RM, Saebo A, Komer H. Influence of failure of primary wound healing on subsequent recurrence of pilonidal sinus. combined prospective study and randomised controlled trial. Eur J Surg. 2002;168(11):614-8. doi: 10.1080/11024150201680007.</citation>
    <PMID>12699097</PMID>
  </reference>
  <reference>
    <citation>Karydakis GE. New approach to the problem of pilonidal sinus. Lancet. 1973 Dec 22;2(7843):1414-5. doi: 10.1016/s0140-6736(73)92803-1. No abstract available.</citation>
    <PMID>4128725</PMID>
  </reference>
  <reference>
    <citation>Schultz GS, Sibbald RG, Falanga V, Ayello EA, Dowsett C, Harding K, Romanelli M, Stacey MC, Teot L, Vanscheidt W. Wound bed preparation: a systematic approach to wound management. Wound Repair Regen. 2003 Mar;11 Suppl 1:S1-28. doi: 10.1046/j.1524-475x.11.s2.1.x.</citation>
    <PMID>12654015</PMID>
  </reference>
  <reference>
    <citation>Gruessner U, Clemens M, Pahlplatz PV, Sperling P, Witte J, Rosen HR; Septocoll Study Group. Improvement of perineal wound healing by local administration of gentamicin-impregnated collagen fleeces after abdominoperineal excision of rectal cancer. Am J Surg. 2001 Nov;182(5):502-9. doi: 10.1016/s0002-9610(01)00762-0.</citation>
    <PMID>11754859</PMID>
  </reference>
  <reference>
    <citation>Lewis R, Whiting P, ter Riet G, O'Meara S, Glanville J. A rapid and systematic review of the clinical effectiveness and cost-effectiveness of debriding agents in treating surgical wounds healing by secondary intention. Health Technol Assess. 2001;5(14):1-131. doi: 10.3310/hta5140.</citation>
    <PMID>11399237</PMID>
  </reference>
  <reference>
    <citation>Armstrong JH, Barcia PJ. Pilonidal sinus disease. The conservative approach. Arch Surg. 1994 Sep;129(9):914-7; discussion 917-9. doi: 10.1001/archsurg.1994.01420330028006.</citation>
    <PMID>8080372</PMID>
  </reference>
  <reference>
    <citation>Clothier PR, Haywood IR. The natural history of the post anal (pilonidal) sinus. Ann R Coll Surg Engl. 1984 May;66(3):201-3.</citation>
    <PMID>6721409</PMID>
  </reference>
  <reference>
    <citation>Blanco G, Giordano M, Torelli I. [Surgical treatment of pilonidal sinus with open surgical technique]. Minerva Chir. 2003 Apr;58(2):181-7. Italian.</citation>
    <PMID>12738928</PMID>
  </reference>
  <reference>
    <citation>Al-Salamah SM, Hussain MI, Mirza SM. Excision with or without primary closure for pilonidal sinus disease. J Pak Med Assoc. 2007 Aug;57(8):388-91.</citation>
    <PMID>17902520</PMID>
  </reference>
  <reference>
    <citation>Irkorucu O, Erdem H, Reyhan E. The best therapy for pilonidal disease: which management for which type? World J Surg. 2012 Mar;36(3):691-2. doi: 10.1007/s00268-011-1285-2. No abstract available.</citation>
    <PMID>21956594</PMID>
  </reference>
  <reference>
    <citation>Anagnostopoulos F, Niakas D, Pappa E. Construct validation of the Greek SF-36 Health Survey. Qual Life Res. 2005 Oct;14(8):1959-65. doi: 10.1007/s11136-005-3866-8.</citation>
    <PMID>16155784</PMID>
  </reference>
  <reference>
    <citation>Blome C, Baade K, Debus ES, Price P, Augustin M. The &quot;Wound-QoL&quot;: a short questionnaire measuring quality of life in patients with chronic wounds based on three established disease-specific instruments. Wound Repair Regen. 2014 Jul-Aug;22(4):504-14. doi: 10.1111/wrr.12193.</citation>
    <PMID>24899053</PMID>
  </reference>
  <reference>
    <citation>Deutsch CJ, Edwards DM, Myers S. Wound dressings. Br J Hosp Med (Lond). 2017 Jul 2;78(7):C103-C109. doi: 10.12968/hmed.2017.78.7.C103. No abstract available.</citation>
    <PMID>28692373</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>May 20, 2021</last_update_submitted>
  <last_update_submitted_qc>May 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Larissa University Hospital</investigator_affiliation>
    <investigator_full_name>Mamaloudis Ioannis</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Pilonidal</keyword>
  <keyword>Fistula</keyword>
  <keyword>Cyst</keyword>
  <keyword>Alginate</keyword>
  <keyword>Gauze</keyword>
  <keyword>Dressings</keyword>
  <keyword>Prospective</keyword>
  <keyword>Randomized Controlled Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cysts</mesh_term>
    <mesh_term>Pilonidal Sinus</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is not a plan to make IPD available.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 27, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT03757572/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 27, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT03757572/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03757572
org study id: Pilonidal QoL
nct id: NCT03757572
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the application of alginate dressings with silver and
      high-G cellulose and the use of simple gauge dressings in patients submitted to surgical
      resection of pilonidal cyst. The present trial will focus on the postoperative quality of
      life during the secondary intention wound healing.
Pilonidal cyst was first described by Hodges in 1880. The disease of pilonidal cyst is also
      known as "Jeep disease", due to the fact that, during World War II (1941-1945), several
      American soldiers (about 80,000) suffered from this disease, because, either they were
      driving for long hours on uneven, destroyed by war, roads, or, they were spending time
      sitting at military vehicles like jeep, trucks and tankers, resulting in being submitted to
      surgical operation, in order to alleviate the arousing pilonidal cyst problem, at USA
      military hospitals.

      Pilonidal cyst, is considered as one of the most common diseases of the subcutaneous tissues
      of the sacrococcygeal region. This situation is the result of hair penetrating into the skin,
      a situation not uncommon in this anatomical area. In a study including 50,000 college
      students, pilonidal cyst occurrence, in males, was 1.1%, which was 10 times higher compared
      to females, although a considerable rate of them was asymptomatic. Evidence from studies in
      England, also, indicate that the disease is more frequent in men than women (1 to 3) . The
      disease is more common in Caucasians than in Asians or Africans due to the differences in
      their hair characteristics and the respective hair development pattern. Risk factors include
      the following: sedentary life (44%), positive family history (38%), obesity (50%) and
      regional irritation (34%). The disease usually presents during the age of 16 - 20 and
      prevalence is decreasing drastically after the 25th year of age. This disease rarely develops
      before the adolescence and after the 40th year of age.

      Treatment usually depends on the condition of the disease. An acute abscess is usually
      controlled with incision and drainage. A chronic pilonidal cyst is best treated with a
      surgical procedure that involves complete resection of the cyst along with the coexisting
      fistulas, in order to ensure the minimum reoccurrence rate. There are two choices after
      surgical resection, secondary intention wound healing or primary trauma closure, with or
      without a flap. The surgical procedure can be performed with the administration of local
      anaesthesia in the outpatient office or in a day-clinic, or with the use of general
      anaesthesia depending on the condition of the patient.

      Post operatively secondary intention wound healing is applied in many cases, especially when
      factors like infection, necrotic tissue or inflammatory tissue are introduced. There are many
      dressings that can be used for the care of a surgical trauma. The ideal dressing used should
      have some special characteristics such as absorption of exudates without leakage, provision
      of a dry environment that prevents bacteria from entering the wound and facilitation of easy
      appliance, as well as removal. Choosing the right dressing is not based on a certain
      protocol, but mostly on the surgeon preference.

      The current study aims at comparing two groups of patients that will be subjected to surgical
      resection of pilonidal cyst and secondary intention wound healing. In the first group,
      dressings like alginate cord with silver and high G cellulose will be used for filling of the
      wound cavity and a hydro-capillary dressing for sealing and waterproofing the wound. In the
      other group, simple gauze dressings for the coverage of the wound cavity will be used.
      Comparison of the two groups will involve all the endpoints that indicate whether such
      dressings can facilitate faster wound healing, enabling, thus, patients to faster return to
      their everyday activities. Furthermore, a parameter that has not been, previously, studied,
      the quality of life after the surgical excision of the pilonidal cyst, by using the SF - 36
      and the Quality of life with Chronic Wound questionnaire, will, also, be investigated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Blinding will exist at the level of the investigator who will record the data postoperatively. There will be no blinding at the level of the surgeon or the patient.
measure: Wound healing time
time frame: Maximum time frame 50 days postoperatively
description: Postoperative required time for wound healing. Measurement unit: days
measure: Postoperative return to everyday activities
time frame: Maximum time frame 50 days postoperatively
description: Time required for returning to everyday activities. Measurement unit: days
measure: Postoperative pain level
time frame: 7, 14, 21, 28, 35, 42 and 49 days postoperatively
description: Pain level after surgery, quantified with the use of the Visual Analogue Scale (0-10). Better outcome: 0, Worse outcome: 10. There will be no subscales or total scores.
measure: Postoperative analgesics consumption
time frame: 7, 14, 21, 28, 35, 42 and 49 days postoperatively
description: Number of analgesic pills consumed per day after surgery. Measurement unit: pills per day
measure: Overall satisfaction level
time frame: 50 days postoperatively
description: Satisfaction level after surgery, quantified with the use of the Visual Analogue Scale (0-10). Better outcome: 10, Worse outcome: 0. There will be no subscales or total scores.
measure: Cost of the material
time frame: Maximum time frame 50 days postoperatively
description: Overall cost of the dressings applied
measure: Wound care visits
time frame: 7, 14, 21, 28, 35, 42 and 49 days postoperatively
description: Number of required visits for postoperative wound care for each patient per week.
measure: Trauma secretions
time frame: 7, 14, 21, 28, 35, 42 and 49 days postoperatively
description: Trauma secretions leading to extra dressing care. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
measure: Wound contamination
time frame: Maximum time frame 50 days postoperatively
description: Contamination of the wound trauma. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
measure: Wound erythema
time frame: Maximum time frame 50 days postoperatively
description: Erythema of the wound. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
measure: Wound haematoma
time frame: Maximum time frame 50 days postoperatively
description: Haematoma of the wound. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
measure: Disease recurrence
time frame: Maximum time frame 1 year postoperatively
description: Disease recurrence rate. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
measure: Difference in the quality of life of the patient
time frame: 7, 14 and 21 days potoperatively
description: Difference in the quality of life of the patient based on the Quality of Life with Chronic Wounds Wounds (Qol) Questionnaire. 17 items in total. Each item quantified with the use of a Visual Ordinal Scale (0='not at all' to 4='very much'). Global score computed by averaging all items. In total 3 subscales calculated by averaging the respective items:
Body: Items #1 to #5. Psyche: Items #6 to #10. Everyday life: Items #11 to #16.
measure: Medium term quality of life
time frame: 28 days postoperatively
description: Quality of life of the patient based on the Short Form 36 (SF-36) questionnaire. 36 items in total. The following ordinal scales will be used for the respective items:
1 (Better)-5 (Worse): #1, #2, #20, #22, #34, #36.
1 (Worse)-3 (Better): #3, to #12.
1 (Worse)-2 (Better): #13, to #19.
1 (Better)-6 (Worse): #21, #23, #26, #27, #30.
1 (Worse)-6 (Better): #24, #25, #28, #29, #31.
1 (Worse)-5 (Better): #32, #33, #35. In total 8 subscales calculated by averaging the respective items. Physical functioning: #3 to #12. Role limitations due to physical health: #13 to #16. Role limitations due to emotional problems: #17 to #19. Energy/fatigue: #23, #27, #29, #31. Emotional well-being: #24 to #26, #28, #30. Social functioning: #20, #32. Pain: #21, #22. General health: #1, #33 to #36.
measure: Treatment satisfaction
time frame: 35 days postoperatively
description: Patient satisfaction regarding the treatment quantified with the use of a Visual Ordinal Scale (1-5). Better outcome: 5, Worse outcome: 1. There will be no subscales or total scores.
measure: Treatment acceptance
time frame: 35 days postoperatively
description: Patient acceptance regarding the re-application of the treatment quantified with the use of a Visual Ordinal Scale (1-5). Better outcome: 5, Worse outcome: 1. There will be no subscales or total scores.
arm group label: Alginate dressings
arm group type: Experimental
description: The pilonidal cyst will be resected, with the use of a scalpel and then haemostasis will be performed with diathermy.
Alginate dressings with silver and high-G cellulose, which combine increased absorption properties, antimicrobial action and high coherence will be used. The size of the dressings will be 3cm X 45cm and 1 cm cord will be used for filling the wound cavity. Dressings with perimetric adhesive layer from natural materials for latent breathing of the skin with dressing dimensions based on the wound size, will be also placed.
Wound care will be performed in a specific way each time that the dressings will be removed. The wound will be irrigated with normal saline and betadine solution and finally without pressure the trauma will be dried.
arm group label: Simple gauze dressings
arm group type: Active Comparator
description: The pilonidal cyst will be resected, with the use of a scalpel and then haemostasis will be performed with diathermy.
Wound care will be performed with the application of simple gauze dressings. Wound care will be performed in a specific way each time that the dressings will be removed. The wound will be irrigated with normal saline and betadine solution and finally without pressure the trauma will be dried.
intervention type: Other
intervention name: Alginate dressings
description: The pilonidal cyst will be resected, with the use of a scalpel and then haemostasis will be performed with diathermy. Alginate dressings with silver and high-G cellulose will be applied to the wound. The size of the dressings will be 3cm X 45cm and 1 cm cord will be used for filling the wound cavity. Dressings with perimetric adhesive layer from natural materials, will be also placed.
During wound care the wound will be irrigated with normal saline and betadine solution and finally without pressure the trauma will be dried.
arm group label: Alginate dressings
intervention type: Other
intervention name: Simple gauze dressings
description: The pilonidal cyst will be resected, with the use of a scalpel and then haemostasis will be performed with diathermy. Simple gauze dressings will be applied to the wound.
During wound care the wound will be irrigated with normal saline and betadine solution and finally without pressure the trauma will be dried.
arm group label: Simple gauze dressings
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ioannis Mamaloudis
role: Principal Investigator
affiliation: Department of Surgery, University Hospital of Larissa
last name: Konstantinos Tepetes
role: Study Director
affiliation: Department of Surgery, University Hospital of Larissa
facility: 
country: Greece
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PMID: 28692373
responsible party type: Principal Investigator
investigator affiliation: Larissa University Hospital
investigator full name: Mamaloudis Ioannis
investigator title: Principal Investigator
mesh term: Cysts
mesh term: Pilonidal Sinus
mesh term: Fistula
sharing ipd: No
ipd description: There is not a plan to make IPD available.
provided document: 
provided document: 