Pilonidal Sinus of Natal CleftPhase 4NCT04560049
Phenol and Silver Nitrate Application in Pilonidal Sinus
A Phase 4 study testing Silver Nitrate and Phenol in people with Pilonidal Sinus of Natal Cleft and Pilonidal Sinus Without Abscess, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Sinus of Natal Cleft, Pilonidal Sinus Without Abscess
- What is being tested?
- Silver Nitrate and Phenol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jun 2020to 15 Jun 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Patients who applied to general surgery outpatient clinic for chronic sacrococcygeal pilonidal sinus
- Patients with written informed voluntary consent forms.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Umraniye Education and Research Hospital
Istanbul, 34764
About this study
Official title: Comparison of Phenol and Silver Nitrate Application in the Sacrococcygeal Pilonidal Sinus: A Prospective Randomized Controlled Study
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
Read the 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.
- Being tested
- Silver Nitrate, Phenol
- Keywords
- Pilonidal Sinus, Phenol, Silver Nitrate
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver NitrateDrug
application of silver nitrate to sinus tract
PhenolDrug
phenolisation of sinus tract
| Study group | Role | What they receive |
|---|---|---|
| Phenolisation | Experimental | Surgical pit excision and phenolisation of sinus tract Receives: Drug: Phenol |
| Silver Nitrate Irrigation | Active comparator | Surgical pit excision and silver nitrate irrigation of sinus tract Receives: Drug: Silver Nitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of the pilonidal sinus disease
Closure of pit without pus and soiling on physical examination
Measured: 8 week
Secondary outcomes (3)
Post-procedure Quality of life assessment
The quality of life of the patients will be determined by SF-36 test.
Measured: 3rd and 8th week after the procedure
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.
Measured: 3rd and 8th week after the procedure
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
Measured: 3rd and 8th week after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start3 Jun 2020
- Primary completion15 Jun 2022
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pilonidal Sinus of Natal CleftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hanife Seyda Ulgur, Umraniye Education and Research Hospital
- Investigators
- Hanife Ş Ülgür, Principal investigator, University of Health Sciences Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560049
- Sponsor's protocol ID
- 2020/206
- Status last verified
- Dec 2024
- First submitted
- 9 Sep 2020
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 1285753Chan 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.
PubMed 23303884Pronk 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.
PubMed 31278458Attaallah 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.
PubMed 24901690Kayaalp 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.
PubMed 19655223Emiroglu 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.
PubMed 28589180
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Phenol and Silver Nitrate Application in the Sacrococcygeal Pilonidal Sinus: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04560049
- Acronym / sponsor ID
- 2020/206
- Keywords
- Pilonidal Sinus, Phenol, Silver Nitrate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenolisation | Experimental | Drug: PhenolSurgical pit excision and phenolisation of sinus tract |
| Silver Nitrate Irrigation | Active comparator | Drug: Silver NitrateSurgical pit excision and silver nitrate irrigation of sinus tract |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years old
- Patients who applied to general surgery outpatient clinic for chronic sacrococcygeal pilonidal sinus
- Patients with written informed voluntary consent forms.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silver Nitrateapplication of silver nitrate to sinus tract | Drug | Silver Nitrate Irrigation |
| Phenolphenolisation of sinus tract | Drug | Phenolisation |
Primary outcome
Healing of the pilonidal sinus disease
Time frame: 8 week
Closure of pit without pus and soiling on physical examination
3 secondary outcomes
Post-procedure Quality of life assessment
Time frame: 3rd and 8th week after the procedure
Wound infection
Time frame: 3rd and 8th week after the procedure
Visual analog scale as pain assessment
Time frame: 3rd and 8th week after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Background: PubMed 1285753Brazier 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.
- Background: PubMed 23303884Chan 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 publication: PubMed 31278458Pronk 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 publication: PubMed 24901690Attaallah 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 publication: PubMed 19655223Kayaalp 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 publication: PubMed 28589180Emiroglu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanife Ş Ülgür principal investigator
University of Health Sciences Umraniye Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Silver Nitrate and Phenol in people with Pilonidal Sinus of Natal Cleft and Pilonidal Sinus Without Abscess, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing of the pilonidal sinus disease (time frame: 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04560049, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.