Pilonidal Sinus Disease: Preliminare Study

Pilonidal Sinus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03764657
• Other study ID #: OCavalese172018
• Status: Completed
• Start date: January 2017
• Est. completion date: February 2018

Study information

• Verified date: November 2018
• Source: Ospedale di Cavalese
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 52 Years

Eligibility

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.

Related Conditions & MeSH terms

• Paranasal Sinus Diseases
• Pilonidal Sinus

Intervention

Procedure:
• 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
• 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

Locations

Country	Name	City	State
Italy	Ospedale di Cavalese	Cavalese	Trento

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale di Cavalese

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	types of complications (Dindo-Clavien)	the type of complication was divided into 2 types, Grade I and II	follow-up 12 months
Secondary	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
Secondary	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)