Pilonidal SinusNCT03764657
Pilonidal Sinus Disease: Preliminare Study
An observational study of Pilonidal Sinus, run by Ospedale di Cavalese at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 52 years
- Conditions the study is for
- Pilonidal Sinus
- What is being tested?
- In "hot" group 16 patients were treated by diathermy in "Cold" and in "Cold" group 13 patients were treated by scalpel.
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 29 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2017to Feb 2018
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 14 to 52 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- flogged or acute or infected or abscessed forms
- ASA score > IV,
- normal range WBC and Hb preoperative values.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pilonidal Sinus
- Being tested
- In "hot" group 16 patients were treated by diathermy in "Cold", in "Cold" group 13 patients were treated by scalpel.
- Keywords
- Pilonidal sinus disease, wound deiscence
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In "hot" group 16 patients were treated by diathermy in "Cold"Procedure or surgery
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
in "Cold" group 13 patients were treated by scalpel.Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 16 patients, named "Hot" group | We considered 16 sinus excision by diathermy as a case group (named "Hot" group) Receives: Procedure: In "hot" group 16 patients were treated by diathermy in "Cold"; Procedure: in "Cold" group 13 patients were treated by scalpel. | |
| 13 patients, named "Cold group" | 13 procedures performed by knife as control group (named "Cold" group). Receives: Procedure: In "hot" group 16 patients were treated by diathermy in "Cold"; Procedure: in "Cold" group 13 patients were treated by scalpel. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of complete wound healed and not healed after 8 postoperative days
We established as primary outcomes, the number of wound completely healed after 8-12 days
Measured: Up to 4 weeks
Secondary outcomes (3)
types of complications (Dindo-Clavien)
the type of complication was divided into 2 types, Grade I and II
Measured: follow-up 12 months
post-operative pain in first postoperative day (analogue pain score, VAS)
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)
Measured: 7 days
operative time for complete excision of the sinus (minutes)
the operative time for complete excision was compared into the two group
Measured: minutes (range 0-30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study startJan 2017
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Ospedale di Cavalese
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764657
- Sponsor's protocol ID
- OCavalese172018
- Status last verified
- Nov 2018
- First submitted
- 25 Nov 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Giuseppe F, Silvia DG, Patrizia R, Riccardo P, Antonio DS, Aldo RS, Angela I, Pietro M, Domenico M, Luciano T. Pilonidal sinus disease: Preliminary case-control study on heat-related wound dehiscence. Ann Med Surg (Lond). 2019 Aug 18;48:144-149. doi: 10.1016/j.amsu.2019.07.032. eCollection 2019 Dec.
PubMed 31890195
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilonidal Sinus Disease: Preliminary Case-control Study on Heat-related Wound Dehiscence
- ClinicalTrials.gov ID
- NCT03764657
- Acronym / sponsor ID
- OCavalese172018
- Conditions
- Pilonidal Sinus
- Keywords
- Pilonidal sinus disease, wound deiscence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Ospedale di CavaleseUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 5 Dec 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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 16 patients, named "Hot" group | – | Procedure: In "hot" group 16 patients were treated by diathermy in "Cold", Procedure: in "Cold" group 13 patients were treated by scalpel.We considered 16 sinus excision by diathermy as a case group (named "Hot" group) |
| 13 patients, named "Cold group" | – | Procedure: In "hot" group 16 patients were treated by diathermy in "Cold", Procedure: in "Cold" group 13 patients were treated by scalpel.13 procedures performed by knife as control group (named "Cold" group). |
Who may qualify
- Ages
- 14 to 52 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
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 |
|---|---|---|
| In "hot" group 16 patients were treated by diathermy in "Cold"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 | Procedure or surgery | 13 patients, named "Cold group", 16 patients, named "Hot" group |
| in "Cold" group 13 patients were treated by scalpel.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 | Procedure or surgery | 13 patients, named "Cold group", 16 patients, named "Hot" group |
Primary outcome
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
3 secondary outcomes
types of complications (Dindo-Clavien)
Time frame: follow-up 12 months
post-operative pain in first postoperative day (analogue pain score, VAS)
Time frame: 7 days
operative time for complete excision of the sinus (minutes)
Time frame: minutes (range 0-30 minutes)
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 5 Dec 2018.
- Derived from this study: PubMed 31890195Giuseppe F, Silvia DG, Patrizia R, Riccardo P, Antonio DS, Aldo RS, Angela I, Pietro M, Domenico M, Luciano T. Pilonidal sinus disease: Preliminary case-control study on heat-related wound dehiscence. Ann Med Surg (Lond). 2019 Aug 18;48:144-149. doi: 10.1016/j.amsu.2019.07.032. eCollection 2019 Dec.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pilonidal Sinus, run by Ospedale di Cavalese at 1 site in Italy.
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 5 inclusion and 9 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 5 Dec 2018. 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 Italy. 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.
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?
Number of complete wound healed and not healed after 8 postoperative days (time frame: Up to 4 weeks). 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 NCT03764657, which also lists 1 linked publication.
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 5 Dec 2018.