Pilonidal SinusNCT03424057
Asymmetric Primary Closure and Additional Skin Excision Technique.
A study testing Asymmetric Primary Closure and Additional Skin Excision Technique and Standard Karydakis technique. in people with Pilonidal Sinus and Pilonidal Disease of Natal Cleft, run by Siverek Devlet Hastanesi.
Trial summary
The aim of this study was to reduce the residual dead-space volume with a modification following the standard Karydakis procedure. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pilonidal Sinus, Pilonidal Disease of Natal Cleft, Surgical Technique
- What is being tested?
- Asymmetric Primary Closure and Additional Skin Excision Technique and Standard Karydakis technique.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2015to 15 Apr 2016
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients between age of 18-65 who had chronic pilonidal disease
Who cannot join
- Patients who did not accept the procedure
- Patients had undergone previous pilonidal sinus surgery
- Patientshad active infection
- Patients who were not minimum of 18 years of age
About this study
Official title: A Novel Technique in the Treatment of Sacrococcygeal Pilonidal Sinus Disease: Effect of Reduction of Dead-space With Asymmetric Primary Closure and Additional Skin Excision Technique.
The aim of this study was to reduce the residual dead-space volume with a modification following the standard Karydakis procedure.
Read the detailed description
All patients were operated in the jack-knife position under spinal anesthesia (SA). The gluteal parts of the patients were stretched in both directions with bandage and intergluteal cleft was opened. Methylen blue was administered from the sinus openings in the gluteal region. Then, total sinus excision was performed, including the entire sinus tracts by passing the skin, subcutaneous tissues up to the presacral fascia.
In patients operated with standard Karydakis procedure, a flap (Karydakis flap) extending along the incision was prepared, with the medial side of the wound to be 1 cm deep and 2-3 cm inward. The prepared flap was shifted to medial and sutured to the presacral fascia with 2/0 vicryl.
In patients who were operated with the Asymmetric Primary Closure with Skin Excision Technique, after the Karydakis flap was formed, 5-10 mm skin was excised along the incision from the side of the flap to reduce the volume of the dead-space laterally.
In both groups, subcutaneous tissue was approximated with 2/0 vicryl. The skin was sutured with mattress technique using 2/0 Prolene. No drains were used in patients from either group.
Patients were followed up for wound leakage, seroma and hematoma formation, skin dehiscence and recurrence.
- Being tested
- Asymmetric Primary Closure and Additional Skin Excision Technique, Standard Karydakis technique.
- Keywords
- Karydakis modification, pilonidal sinus, seroma
- Medical subject headings
- Pilonidal Sinus, Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asymmetric Primary Closure and Additional Skin Excision TechniqueProcedure or surgery
In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method, but an advancement tissue flap was performed using additional skin excision, in order to reduce the dead-space volume.
Standard Karydakis technique.Procedure or surgery
In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1 were treated with the new technique (Asymmetric Primary Closure and Additional Skin Excision).
In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method, but an advancement tissue flap was performed using additional skin excision, in order to reduce the dead-space volume. Receives: Procedure: Asymmetric Primary Closure and Additional Skin Excision Technique |
| Group 2 | Active comparator | Group 2 were treated with the standard Karydakis technique. Receives: Procedure: Standard Karydakis technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early postoperative complications.
wound dehiscence, formation of seroma, hematoma, wound infection
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start15 Apr 2015
- Primary completion25 Mar 2016
- Study completion15 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal SinusStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siverek Devlet Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulcabbar Kartal, Siverek Devlet Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424057
- Sponsor's protocol ID
- 74059997.050.01.04/79
- Status last verified
- Feb 2018
- First submitted
- 30 Jan 2018
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study has been completed. The datas will be shared as an article
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Technique in the Treatment of Sacrococcygeal Pilonidal Sinus Disease: Effect of Reduction of Dead-space With Asymmetric Primary Closure and Additional Skin Excision Technique.
- ClinicalTrials.gov ID
- NCT03424057
- Acronym / sponsor ID
- 74059997.050.01.04/79
- Keywords
- Karydakis modification, pilonidal sinus, seroma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Siverek Devlet HastanesiUniversity, hospital or other
- Study start
- 15 Apr 2015 (actual)
- Primary completion
- 25 Mar 2016 (actual)
- Study completion
- 15 Apr 2016 (actual)
- First posted
- 6 Feb 2018 (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.
The aim of this study was to reduce the residual dead-space volume with a modification following the standard Karydakis procedure.
Detailed description
All patients were operated in the jack-knife position under spinal anesthesia (SA). The gluteal parts of the patients were stretched in both directions with bandage and intergluteal cleft was opened. Methylen blue was administered from the sinus openings in the gluteal region. Then, total sinus excision was performed, including the entire sinus tracts by passing the skin, subcutaneous tissues up to the presacral fascia.
In patients operated with standard Karydakis procedure, a flap (Karydakis flap) extending along the incision was prepared, with the medial side of the wound to be 1 cm deep and 2-3 cm inward. The prepared flap was shifted to medial and sutured to the presacral fascia with 2/0 vicryl.
In patients who were operated with the Asymmetric Primary Closure with Skin Excision Technique, after the Karydakis flap was formed, 5-10 mm skin was excised along the incision from the side of the flap to reduce the volume of the dead-space laterally.
In both groups, subcutaneous tissue was approximated with 2/0 vicryl. The skin was sutured with mattress technique using 2/0 Prolene. No drains were used in patients from either group.
Patients were followed up for wound leakage, seroma and hematoma formation, skin dehiscence and recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: Asymmetric Primary Closure and Additional Skin Excision TechniqueGroup 1 were treated with the new technique (Asymmetric Primary Closure and Additional Skin Excision). In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method, but an advancement tissue flap was performed using additional skin excision, in order to reduce the dead-space volume. |
| Group 2 | Active comparator | Procedure: Standard Karydakis technique.Group 2 were treated with the standard Karydakis technique. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients between age of 18-65 who had chronic pilonidal disease
Key exclusion criteria (4 listed)
- Patients who did not accept the procedure
- Patients had undergone previous pilonidal sinus surgery
- Patientshad active infection
- Patients who were not minimum of 18 years of age
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 |
|---|---|---|
| Asymmetric Primary Closure and Additional Skin Excision TechniqueIn this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method, but an advancement tissue flap was performed using additional skin excision, in order to reduce the dead-space volume. | Procedure or surgery | Group 1 |
| Standard Karydakis technique.In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method | Procedure or surgery | Group 2 |
Primary outcome
Early postoperative complications.
Time frame: 3 years
wound dehiscence, formation of seroma, hematoma, wound infection
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 Feb 2018.
- Individual participant dataSharing planned: Yes. The study has been completed. The datas will be shared as an article
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Asymmetric Primary Closure and Additional Skin Excision Technique and Standard Karydakis technique. in people with Pilonidal Sinus and Pilonidal Disease of Natal Cleft, run by Siverek Devlet Hastanesi.
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 1 inclusion and 4 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 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Early postoperative complications. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2018.