Pilonidal Sinus Disease: Preliminare Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilonidal Sinus Disease: Preliminary Case-control Study on Heat-related Wound Dehiscence

Conditions
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Pilonidal Sinus

Intervention / Treatment
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* Procedure: In hot group 16 patients were treated by diathermy in Cold
* Procedure: in Cold group 13 patients were treated by scalpel.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 52 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 16 patients, named Hot group<br>We considered 16 sinus excision by diathermy as a case group (named Hot group) | Procedure: In hot group 16 patients were treated by diathermy in Cold<br>* 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<br>Procedure: in Cold group 13 patients were treated by scalpel.<br>* 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<br>|
| 13 patients, named Cold group<br>13 procedures performed by knife as control group (named Cold group). | Procedure: In hot group 16 patients were treated by diathermy in Cold<br>* 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<br>Procedure: in Cold group 13 patients were treated by scalpel.<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| types of complications (Dindo-Clavien) | 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) | 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) | the operative time for complete excision was compared into the two group | minutes (range 0-30 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pilonidal sinus disease, wound deiscence