PILONIDAL SINUSNCT02574936
Reduction Dead Space Volume With Karydakis Modification
A study testing A new surgical technique in people with PILONIDAL SINUS, run by Siverek Devlet Hastanesi.
Trial summary
The purpose of this study is to reduce the volume of dead space by a modification in kardakis flap procedure and consequently, to reduce the use of drains, wound drainage, seroma and hematoma formation, skin degradation and recurrence rates. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- PILONIDAL SINUS
- What is being tested?
- A new surgical technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Sep 2015
- 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 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients older than 18 years
- patients who accept the procedure
- chronic p.sinüs disease
Who cannot join
- previous sinüs surgery
- active infection
- patients who did not accept the procedure
- patients under age of 18.
About this study
Official title: Effects of Reduction Dead Space Volume With Karydakis Modification
The purpose of this study is to reduce the volume of dead space by a modification in kardakis flap procedure and consequently, to reduce the use of drains, wound drainage, seroma and hematoma formation, skin degradation and recurrence rates.
Read the detailed description
The study was a pilot study of 80 patients. Excluding criteria were previous sinüs surgery, active infection, patients who did not accept the procedure and patients under age of 18. After excision of the sinüs volume was measured using a beaker. A flap extending across the cut (Karydakis) was prepared in medial edge of the wound, 1 cm deep and 2 to 3 cm to be towards the interior. Prepared flap was shifted to the medial and sutured to presacral fascia with vicryl 2/0. To reduce the volume of the dead space formed in the lateral, 5 mm skin was excised along the incision in the flap side. Skin was approximated with sutures in the form of intermittent, using 2/0 poliprolen. No drain used. All patients were discharged on postoperative day 1. Sutures were removed 2 weeks later. All patients for at least 6 months were followed for wound drainage, seroma and hematoma formation, separation of skin and and recurrence.
- Conditions
- PILONIDAL SINUS
- Being tested
- A new surgical technique
- Keywords
- karydakis modification, pilonidal sinus, complication
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A new surgical techniqueProcedure or surgery
Also called Modified Karydakis
Description of a new surgical technique in pilonidal sinüs surgery in order to reduce dead space volume.
A flap extending across the cut (Karydakis) is prepared in medial edge of the wound, 1 cm deep and 2 to 3 cm to be towards the interior. Prepared flap is shifted to the medial and sutured to presacral fascia with vicryl 2/0. To reduce the volume of the dead space formed in the lateral, 5 mm skin is excised along the incision in the flap side. Skin is approximated with sutures in the form of intermittent, using 2/0 poliprolen. No drain used
| Study group | Role | What they receive |
|---|---|---|
| modified Karydakis,surgical technique | Other | a new surgical technique(modified Karydakis) to be compared with standard Karydakis Receives: Procedure: A new surgical technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of reducing the dead space volume (Change in dead space volume) with a modification in The Karydakis Method in sacrococcygeal pilonidal sinus surgery
OUTCOME MEASURE:
- Extracted sinus volume
- The number of patients with complications
- Delayed wound healing
- seroma
- hematoma formation
- wound infection
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startJan 2014
- Primary completionAug 2015
- Study completionSep 2015
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siverek Devlet Hastanesi
- Sponsor type
- University, hospital or other
- Collaborators
- Harran University
- Responsible party
- Principal investigator, Abdulcabbar Kartal, Siverek Devlet Hastanesi
- Investigators
- Ali Uzunköy, Study director, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574936
- Sponsor's protocol ID
- 74059997.050.01.04/77
- Status last verified
- Oct 2015
- First submitted
- 8 Oct 2015
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Reduction Dead Space Volume With Karydakis Modification
- ClinicalTrials.gov ID
- NCT02574936
- Acronym / sponsor ID
- 74059997.050.01.04/77
- Conditions
- PILONIDAL SINUS
- Keywords
- karydakis modification, pilonidal sinus, complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Siverek Devlet HastanesiUniversity, hospital or other
- Collaborators
- Harran University
- Study start
- Jan 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 14 Oct 2015 (estimated)
- 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 purpose of this study is to reduce the volume of dead space by a modification in kardakis flap procedure and consequently, to reduce the use of drains, wound drainage, seroma and hematoma formation, skin degradation and recurrence rates.
Detailed description
The study was a pilot study of 80 patients. Excluding criteria were previous sinüs surgery, active infection, patients who did not accept the procedure and patients under age of 18. After excision of the sinüs volume was measured using a beaker. A flap extending across the cut (Karydakis) was prepared in medial edge of the wound, 1 cm deep and 2 to 3 cm to be towards the interior. Prepared flap was shifted to the medial and sutured to presacral fascia with vicryl 2/0. To reduce the volume of the dead space formed in the lateral, 5 mm skin was excised along the incision in the flap side. Skin was approximated with sutures in the form of intermittent, using 2/0 poliprolen. No drain used. All patients were discharged on postoperative day 1. Sutures were removed 2 weeks later. All patients for at least 6 months were followed for wound drainage, seroma and hematoma formation, separation of skin and and recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| modified Karydakis,surgical technique | Other | Procedure: A new surgical techniquea new surgical technique(modified Karydakis) to be compared with standard Karydakis |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients older than 18 years
- patients who accept the procedure
- chronic p.sinüs disease
Key exclusion criteria (4 listed)
- previous sinüs surgery
- active infection
- patients who did not accept the procedure
- patients under age of 18.
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 |
|---|---|---|
| A new surgical techniqueAlso: Modified KarydakisDescription of a new surgical technique in pilonidal sinüs surgery in order to reduce dead space volume. A flap extending across the cut (Karydakis) is prepared in medial edge of the wound, 1 cm deep and 2 to 3 cm to be towards the interior. Prepared flap is shifted to the medial and sutured to presacral fascia with vicryl 2/0. To reduce the volume of the dead space formed in the lateral, 5 mm skin is excised along the incision in the flap side. Skin is approximated with sutures in the form of intermittent, using 2/0 poliprolen. No drain used | Procedure or surgery | modified Karydakis,surgical technique |
Primary outcome
Effects of reducing the dead space volume (Change in dead space volume) with a modification in The Karydakis Method in sacrococcygeal pilonidal sinus surgery
Time frame: 18 months
OUTCOME MEASURE: 1. Extracted sinus volume 2. The number of patients with complications 1. Delayed wound healing 2. seroma 3. hematoma formation 4. 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 14 Oct 2015.
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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.
Ali Uzunköy study director
Harran University
Questions about this trial
What is this clinical trial studying?
A study testing A new surgical technique in people with PILONIDAL SINUS, 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 3 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 14 Oct 2015. 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?
Effects of reducing the dead space volume (Change in dead space volume) with a modification in The Karydakis Method in sacrococcygeal pilonidal sinus surgery (time frame: 18 months). 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 14 Oct 2015.