Phenol and Silver Nitrate Application in Pilonidal Sinus

NCT04560049 | Completed Phase 4

• 1 other identifier: 2020/206
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

Pilonidal Sinus of Natal Cleft; Pilonidal Sinus Without Abscess

Keywords

Pilonidal Sinus; Phenol; Silver Nitrate

Outcome Measures

Primary Outcomes (1)

• Healing of the pilonidal sinus disease

  Closure of pit without pus and soiling on physical examination

  8 week

Secondary Outcomes (3)

• Post-procedure Quality of life assessment

  3rd and 8th week after the procedure

• Wound infection

  3rd and 8th week after the procedure

• Visual analog scale as pain assessment

  3rd and 8th week after the procedure

Study Arms (2)

Phenolisation

EXPERIMENTAL

Surgical pit excision and phenolisation of sinus tract

Drug: Phenol

Silver Nitrate Irrigation

ACTIVE COMPARATOR

Surgical pit excision and silver nitrate irrigation of sinus tract

Drug: Silver Nitrate

Interventions

Silver Nitrate DRUG

application of silver nitrate to sinus tract

Silver Nitrate Irrigation

Phenol DRUG

phenolisation of sinus tract

Phenolisation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Study Sites (1)

University of Health Sciences Umraniye Education and Research Hospital

Istanbul, 34764, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 1285753 BACKGROUND

• 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.

  PMID: 23303884 BACKGROUND

• 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.

  PMID: 31278458 RESULT

• 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.

  PMID: 24901690 RESULT

• 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.

  PMID: 19655223 RESULT

• 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.

  PMID: 28589180 RESULT

MeSH Terms

Conditions

Pilonidal Sinus

Interventions

Silver Nitrate; Phenol

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Intervention Hierarchy (Ancestors)

Nitrates; Nitric Acid; Nitrogen Compounds; Inorganic Chemicals; Silver Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Hanife Ş Ülgür

  University of Health Sciences Umraniye Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Doctor

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 23, 2020
• Study Start: June 3, 2020
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2023
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

TU (1)