- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03764657
Pilonidal Sinus Disease: Preliminare Study
December 4, 2018 updated by: Ospedale di Cavalese
Pilonidal Sinus Disease: Preliminary Case-control Study on Heat-related Wound Dehiscence
Pilonidal disease is morbid condition of young productive population, that could impair quality of life with high cost for health care system.
No consensus exists on optimal surgical treatment, even if several techniques have been proposed.
In this preliminary experimental case-control study the investigators compared excision by knife and diathermy with the aim to investigate if wound dehiscence could be related to heat spreading during excision of the sinus.
Study Overview
Status
Completed
Conditions
Detailed Description
Between January 2017 and February 2018, 29 patients underwent to sinus excision.
The investigators considered 16 sinus excision performed by diathermy as a case group (named "Hot" group) and the last 13 procedures performed by knife as control group (named "Cold" group).
Temperature data were recorded for both group.
Follow-up was carried out until complete healing.
Were considered primary and secondary outcomes.
Study Type
Observational
Enrollment (Actual)
29
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Trento
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Cavalese, Trento, Italy, 38033
- Ospedale di Cavalese
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 50 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All patients were enrolled by outpatient surgical control for signs and symptoms of chronic sinus referred to us by a family doctor; median age was 19.2 ± 4.3 years, ranging from 14 to 52 years old; 6 patients were females and 23 males and them were request to give informed consensus to underwent to pilonidal sinus excision; 16 patients of whom 12 males and 4 females, were treated by electrosurgery as case group ("hot"), while in the control group ("cold"), 13 patients 11 were male and 2 were females.
Description
Inclusion Criteria:
- male and female patients between 14 and 65 years old,
- primary, non recurrent pilonidal disease
- midline and intergluteal location
- spinal anesthesia
- dimension no more than 5 cm in length, primary closure performed
Exclusion Criteria:
- age < 14 and > 65 years old,
- secondary fistulous tracts or lateral developing/cutaneous opening
- dimension over 5 cm in length,
- local anesthesia employ
- smoker and obese patients (BMI> 25 kg/m2)
- diabetic and coagulopathies affected one
- flogged or acute or infected or abscessed forms
- ASA score > IV,
- normal range WBC and Hb preoperative values.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
16 patients, named "Hot" group
We considered 16 sinus excision by diathermy as a case group (named "Hot" group)
|
In all interventions, the patients were placed in prone position on operating table with the gluteal line opened wide by adhesive patches; after skin disinfection, dimension and extension of cystic disease was studied by injection of hydrogen peroxide through superficial skin orifice.
The same procedure was performed: an elliptical incision on midline around the sinus was made and the sinus was excided laterally and in depth on healthy tissue, down till the pre-sacral fascia: this common approach was made both using scalpel and electrosurgery in the two groups.
During dissection and excision, in each group were measured and recorded the temperatures developing, both on the section surface using an infrared thermometer and thermal imaging camera, and deeper until 1 cm from the section frontline using a "immersion thermometer" sealed by a steri-drape to guarantee the sterility on surgical field.
In this group excision was carried out with diatermocoagulation
the position and preparation of the patient on the operating table were the same as in the "hot" group, while the excision procedure performed with knife
|
13 patients, named "Cold group"
13 procedures performed by knife as control group (named "Cold" group).
|
In all interventions, the patients were placed in prone position on operating table with the gluteal line opened wide by adhesive patches; after skin disinfection, dimension and extension of cystic disease was studied by injection of hydrogen peroxide through superficial skin orifice.
The same procedure was performed: an elliptical incision on midline around the sinus was made and the sinus was excided laterally and in depth on healthy tissue, down till the pre-sacral fascia: this common approach was made both using scalpel and electrosurgery in the two groups.
During dissection and excision, in each group were measured and recorded the temperatures developing, both on the section surface using an infrared thermometer and thermal imaging camera, and deeper until 1 cm from the section frontline using a "immersion thermometer" sealed by a steri-drape to guarantee the sterility on surgical field.
In this group excision was carried out with diatermocoagulation
the position and preparation of the patient on the operating table were the same as in the "hot" group, while the excision procedure performed with knife
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of complete wound healed and not healed after 8 postoperative days
Time Frame: Up to 4 weeks
|
We established as primary outcomes, the number of wound completely healed after 8-12 days
|
Up to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
types of complications (Dindo-Clavien)
Time Frame: follow-up 12 months
|
the type of complication was divided into 2 types, Grade I and II
|
follow-up 12 months
|
post-operative pain in first postoperative day (analogue pain score, VAS)
Time Frame: 7 days
|
postoperative pain was recorded in the two groups using the analog pain scale (VAS, range 0-10, the lowest value indicates less pain and the highest value indicates)
|
7 days
|
operative time for complete excision of the sinus (minutes)
Time Frame: minutes (range 0-30 minutes)
|
the operative time for complete excision was compared into the two group
|
minutes (range 0-30 minutes)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
February 1, 2018
Study Completion (Actual)
February 1, 2018
Study Registration Dates
First Submitted
November 25, 2018
First Submitted That Met QC Criteria
December 4, 2018
First Posted (Actual)
December 5, 2018
Study Record Updates
Last Update Posted (Actual)
December 5, 2018
Last Update Submitted That Met QC Criteria
December 4, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OCavalese172018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pilonidal Sinus
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Northwell HealthPediatric Surgical Research CollaborativeActive, not recruitingPilonidal Disease | Pilonidal Sinus Without Abscess | Pilonidal Cyst/Fistula | Pilonidal Cyst Without Abscess | Pilonidal Cyst and Sinus Without Abscess | Pilonidal Abscess | Pilonidal Sinus With Abscess | Pilonidal Dimple With Abscess | Pilonidal Fistula With Abscess | Pilonidal Sinus Infected | Pilonidal... and other conditionsUnited States
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dr. IJM Han-GeurtsUMC Utrecht; Albert Schweitzer Hospital; Flevoziekenhuis; Ziekenhuis Amstelland; Proctos... and other collaboratorsNot yet recruitingPilonidal Sinus | Pilonidal Disease | Pilonidal Sinus of Natal Cleft | Pilonidal Sinus Without Abscess | Pilonidal Disease of Natal Cleft
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