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Pilonidal Sinus Disease: Preliminare Study

NCT03764657 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 29

Last updated 2018-12-05

No results posted yet for this study

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.

Conditions

  • Pilonidal Sinus

Interventions

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

Sponsors & Collaborators

  • Ospedale di Cavalese

    lead OTHER

Eligibility

Min Age
14 Years
Max Age
52 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03764657 on ClinicalTrials.gov