Pilonidal Sinus Disease: Preliminare Study

NCT ID: NCT03764657

Last Updated: 2018-12-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 29 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-02-28

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

16 patients, named "Hot" group

We considered 16 sinus excision by diathermy as a case group (named "Hot" group)

In "hot" group 16 patients were treated by diathermy in "Cold"

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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 "hot" group 16 patients were treated by diathermy in "Cold"

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 52 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale di Cavalese

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ospedale di Cavalese

Cavalese, Trento, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 31890195 (View on PubMed)

Other Identifiers

OCavalese172018

Identifier Type: -

Identifier Source: org_study_id