Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000868886
Ethics application status
Approved
Date submitted
7/08/2012
Date registered
16/08/2012
Date last updated
30/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the two treatment modalities (crystallized phenol application vs. surgical treatment) for pilonidal sinus disease
Scientific title
Comparison of crystallized phenol application and surgery on quality of life and pain in patients for pilonidal sinus disease
Secondary ID [1] 280991 0
nil
Universal Trial Number (UTN)
U1111-1132-8634
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
patients with pilonidal sinus disease 287121 0
Condition category
Condition code
Surgery 287442 287442 0 0
Surgical techniques
Infection 287498 287498 0 0
Other infectious diseases
Skin 287499 287499 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients were randomized to 2 groups according to applied treatment protocol
Group 1: Crystallized phenol will be applied into pilonidal sinus tract. The amount of the crystallized phenol will differ according to the patients sinus tract. the patient will be followed for three weeks for wound healing. Closure of the sinus tract in three weeks will be accepted as cure. In case of failure in the healing of sinus tract in three weeks, the crystallized phenol application will be performed respectively.
Group 2: Surgical technique either primary closure or marsupialization will be performed. primary closure for patients who does not have infection on the surgical site and marsupialization for patients who had acute infection on surgical site were the reason for surgery technique . For both techniques the duration of surgery were estimated as 1 hour. The patients follow up will continue until the full wound healing occurs.
Intervention code [1] 285441 0
Treatment: Drugs
Intervention code [2] 285442 0
Treatment: Surgery
Comparator / control treatment
In the control group surgical technique; either primary closure or marsupialization will be performed.
Control group
Active

Outcomes
Primary outcome [1] 287708 0
quality of life after treatment
Timepoint [1] 287708 0
Assessed before the procedure, first day after the procedure and three weeks after the procedure with SF36 and NHP questionnaires
Secondary outcome [1] 298668 0
Pain
Timepoint [1] 298668 0
Assessed wit VAS at;
the first hour after the procedure
at 12th, 24th and 48th hour after the procedure
and at the 1st week after the procedure

Eligibility
Key inclusion criteria
patients with pilonidal sinus disease
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with acute abcess

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization was used to keep the sample size of the groups similar. Random Allocation Software (Ver. 1.0.0) was used to allocate the patients to groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 4465 0
Turkey
State/province [1] 4465 0
Ankara

Funding & Sponsors
Funding source category [1] 285777 0
Self funded/Unfunded
Name [1] 285777 0
Country [1] 285777 0
Primary sponsor type
Individual
Name
Kamil Gulpinar
Address
Ufuk university school of medicine ,general surgery department
Mevlana Bulvari (Konya Yolu) No:86-88
06520 Balgat - ANKARA
Country
Turkey
Secondary sponsor category [1] 284600 0
None
Name [1] 284600 0
Address [1] 284600 0
Country [1] 284600 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287784 0
Ankara University School of Medicine Ethical Committee
Ethics committee address [1] 287784 0
Ankara university school of medicine ,main building
Sihhiye PK 06100 Ankara /turkey
Ethics committee country [1] 287784 0
Turkey
Date submitted for ethics approval [1] 287784 0
28/05/2012
Approval date [1] 287784 0
11/06/2012
Ethics approval number [1] 287784 0

Summary
Brief summary
Pilonidal sinus disease is an acquired disease at the sacrococcygeal region that can be treated by a number of surgical techniques. Crystallized phenol application seems to be an alternative therapy for pilonidal sinus disease with higher success rates, lower costs, faster recovery and earlier return to work. The aim of this presentation is to compare the crystallized phenol application and surgery for pilonidal sinus disease .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34551 0
A/Prof Kamil Gulpinar
Address 34551 0
UFUK university school of medicine general surgery department Mevlana Bulvari (Konya Yolu) No:86-88 06520 Balgat - ANKARA
Country 34551 0
Turkey
Phone 34551 0
+905327470269
Fax 34551 0
Email 34551 0
[email protected]
Contact person for public queries
Name 17798 0
A/Prof Kamil Gulpinar
Address 17798 0
UFUK university school of medicine general surgery department
Mevlana Bulvari (Konya Yolu) No:86-88
06520 Balgat - ANKARA
Country 17798 0
Turkey
Phone 17798 0
+90 312 204 43 06
Fax 17798 0
+90 312 287 23 90
Email 17798 0
[email protected]
Contact person for scientific queries
Name 8726 0
A/Prof Kamil Gulpinar
Address 8726 0
UFUK university school of medicine general surgery department
Mevlana Bulvari (Konya Yolu) No:86-88
06520 Balgat - ANKARA
Country 8726 0
Turkey
Phone 8726 0
+90 312 204 43 06
Fax 8726 0
+90 312 287 23 90
Email 8726 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePhenol Injection Versus Excision with Open Healing in Pilonidal Disease: A Prospective Randomized Trial.2017https://dx.doi.org/10.1097/DCR.0000000000000717
N.B. These documents automatically identified may not have been verified by the study sponsor.