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Phenol and Silver Nitrate Application in Pilonidal Sinus

Primary Purpose

Pilonidal Sinus of Natal Cleft, Pilonidal Sinus Without Abscess

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Silver Nitrate
Phenol
Sponsored by
Umraniye Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pilonidal Sinus of Natal Cleft focused on measuring Pilonidal Sinus, Phenol, Silver Nitrate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 18 years old
  • Patients who applied to general surgery outpatient clinic for chronic sacrococcygeal pilonidal sinus
  • Patients with written informed voluntary consent forms.

Exclusion Criteria:

  • BMI > 35 kg/m²
  • Recurrent cases
  • Active abscess formation
  • Patients with hydradenitis suppurativa and skin lesions in the perianal region
  • Patients with accompanying anal fistula, anal conduloma and perianal involvement of Crohn's disease
  • Immunosuppressive patients (HIV +, organ transplantation, patients receiving immunosuppressive therapy)
  • Complicated cases (have more than 3 orifice)
  • Patients with known allergic sensitivity to one of the silver nitrate, phenol, nitrofurazone and prilocaine substances

Sites / Locations

  • University of Health Sciences Umraniye Education and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Phenolisation

Silver Nitrate Irrigation

Arm Description

Surgical pit excision and phenolisation of sinus tract

Surgical pit excision and silver nitrate irrigation of sinus tract

Outcomes

Primary Outcome Measures

Healing of the pilonidal sinus disease
Closure of pit without pus and soiling on physical examination

Secondary Outcome Measures

Post-procedure Quality of life assessment
The quality of life of the patients will be determined by SF-36 test.
Wound infection
Wound infection is simply classifed as present or not present. It is considered as present when there was a an odd smelling purulent discharge from the wound.
Visual analog scale as pain assessment
Pain of the patients will be determined by VAS (visual analog scale). Patients are simply asked to score their pain from 1 to 10, which is typically called visual analog scale in the literature, with higher scores representing more severe pain

Full Information

First Posted
September 9, 2020
Last Updated
July 5, 2021
Sponsor
Umraniye Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04560049
Brief Title
Phenol and Silver Nitrate Application in Pilonidal Sinus
Official Title
Comparison of Phenol and Silver Nitrate Application in the Sacrococcygeal Pilonidal Sinus: A Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 3, 2020 (Actual)
Primary Completion Date
June 15, 2022 (Anticipated)
Study Completion Date
June 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umraniye Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pilonidal sinus is a disease that affects the young population. Wound healing is a problem after surgical interventions Especially wound healing brings minimally invasive interventions to the fore. In this study we will administer two types of irritating agent for pilonidal sinus disesase. One of them is phenol and second one is silver nitrate solution. And not routinely used for pilonidal sinus disease. The data about availeble in pubmed and google scholar is limited focused on silver nitrate The goal of the study is to compare the silver nitrate and phenol application
Detailed Description
Sacrococcygeal pilonidal sinus disease is a chronic subcutaneous tissue inflammation that most commonly affects the male sex between the ages of 20 and 30, characterized by burning, itching and discharge in the internal gluteal cleft. It affects the young working population, short return to work after treatment and early return to daily normal activity is socioeconomically important. Although approximately 15 different surgical techniques have been described in the literature in the treatment of pilonidal sinus, a gold standard approach has not been determined. Since it is seen in the young working population, it is important that the ideal treatment has an easy-to-apply, low cost and fast recovery process. The effectiveness of phenol administration as a minimally invasive procedure has been demonstrated with acceptable complication and success rates in prospective and retrospective studies. Silver nitrate is a caustic and sclerosing substance that impairs tract integrity, such as phenol. It supports the closure of the sinus tract by cauterizing the granulation and epithelialized tissue throughout the sinus. It also has antimicrobial properties to reduce microbial load throughout the tract. Although the effective use and successful results of silver nitrate in the treatment of perianal fistula have been shown, a prospective study has not been conducted yet on the use of pilonidal sinus. The main purpose of the study is to compare return to normal daily activity between the two groups. This period will be measured in days from the intervention. Participants will not be offered any restrictions after the intervention, and the period of returning to normal daily activities such as starting work at work or doing the housework will be determined by filling out a two-week daily questionnaire. Secondary goals; quality of life, complaints related to pilonidal sinus (itching, burning, discharge), wound infection, closure of pilonidal sinus mouth, recurrence rate and VAS (visual analog scale) scoring.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Sinus of Natal Cleft, Pilonidal Sinus Without Abscess
Keywords
Pilonidal Sinus, Phenol, Silver Nitrate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phenolisation
Arm Type
Experimental
Arm Description
Surgical pit excision and phenolisation of sinus tract
Arm Title
Silver Nitrate Irrigation
Arm Type
Active Comparator
Arm Description
Surgical pit excision and silver nitrate irrigation of sinus tract
Intervention Type
Drug
Intervention Name(s)
Silver Nitrate
Intervention Description
application of silver nitrate to sinus tract
Intervention Type
Drug
Intervention Name(s)
Phenol
Intervention Description
phenolisation of sinus tract
Primary Outcome Measure Information:
Title
Healing of the pilonidal sinus disease
Description
Closure of pit without pus and soiling on physical examination
Time Frame
8 week
Secondary Outcome Measure Information:
Title
Post-procedure Quality of life assessment
Description
The quality of life of the patients will be determined by SF-36 test.
Time Frame
3rd and 8th week after the procedure
Title
Wound infection
Description
Wound infection is simply classifed as present or not present. It is considered as present when there was a an odd smelling purulent discharge from the wound.
Time Frame
3rd and 8th week after the procedure
Title
Visual analog scale as pain assessment
Description
Pain of the patients will be determined by VAS (visual analog scale). Patients are simply asked to score their pain from 1 to 10, which is typically called visual analog scale in the literature, with higher scores representing more severe pain
Time Frame
3rd and 8th week after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years old Patients who applied to general surgery outpatient clinic for chronic sacrococcygeal pilonidal sinus Patients with written informed voluntary consent forms. Exclusion Criteria: BMI > 35 kg/m² Recurrent cases Active abscess formation Patients with hydradenitis suppurativa and skin lesions in the perianal region Patients with accompanying anal fistula, anal conduloma and perianal involvement of Crohn's disease Immunosuppressive patients (HIV +, organ transplantation, patients receiving immunosuppressive therapy) Complicated cases (have more than 3 orifice) Patients with known allergic sensitivity to one of the silver nitrate, phenol, nitrofurazone and prilocaine substances
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanife Ş Ülgür
Phone
+905058302130
Email
hanifeseydaulgur@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanife Ş Ülgür
Organizational Affiliation
University of Health Sciences Umraniye Education and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Health Sciences Umraniye Education and Research Hospital
City
İstanbul
ZIP/Postal Code
34764
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanife Ş Ülgür
Phone
05058302130
Email
hanifeseydaulgur@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
1285753
Citation
Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992 Jul 18;305(6846):160-4. doi: 10.1136/bmj.305.6846.160.
Results Reference
background
PubMed Identifier
23303884
Citation
Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
Results Reference
background
PubMed Identifier
31278458
Citation
Pronk AA, Smakman N, Furnee EJB. Short-term outcomes of radical excision vs. phenolisation of the sinus tract in primary sacrococcygeal pilonidal sinus disease: a randomized-controlled trial. Tech Coloproctol. 2019 Jul;23(7):665-673. doi: 10.1007/s10151-019-02030-w. Epub 2019 Jul 5.
Results Reference
result
PubMed Identifier
24901690
Citation
Attaallah W, Tuney D, Gulluoglu BM, Ugurlu MU, Gunal O, Yegen C. Should we consider topical silver nitrate irrigation as a definitive nonsurgical treatment for perianal fistula? Dis Colon Rectum. 2014 Jul;57(7):882-7. doi: 10.1097/DCR.0000000000000143.
Results Reference
result
PubMed Identifier
19655223
Citation
Kayaalp C, Aydin C. Review of phenol treatment in sacrococcygeal pilonidal disease. Tech Coloproctol. 2009 Sep;13(3):189-93. doi: 10.1007/s10151-009-0519-x. Epub 2009 Aug 5.
Results Reference
result
PubMed Identifier
28589180
Citation
Emiroglu M, Karaali C, Esin H, Akpinar G, Aydin C. Treatment of pilonidal disease by phenol application. Turk J Surg. 2017 Mar 1;33(1):5-9. doi: 10.5152/UCD.2016.3532. eCollection 2017.
Results Reference
result

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Phenol and Silver Nitrate Application in Pilonidal Sinus

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