NCT03764657

Pilonidal Sinus Disease: Preliminare Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 29 (actual)
• Sponsor: Ospedale di Cavalese · Academic / Other
• Sex: All
• Age: 14 Years – 52 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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
PROCEDURE	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

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2018-12-05
• Last updated: 2018-12-05

Locations

1 site across 1 country: Italy