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Completed

NCT Number: NCT03764657

Pilonidal Sinus Disease: Preliminare Study

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.

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Key information

Conditions

Pilonidal Sinus Cysts Neoplasms

Age range

14 year–52 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale di Cavalese

Cavalese, Trento, 38033, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

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

Primary outcomes

  1. Number of complete wound healed and not healed after 8 postoperative days

    Time frame: Up to 4 weeks

    We established as primary outcomes, the number of wound completely healed after 8-12 days

Secondary outcomes

  1. types of complications (Dindo-Clavien)

    Time frame: follow-up 12 months

    the type of complication was divided into 2 types, Grade I and II

  2. post-operative pain in first postoperative day (analogue pain score, VAS)

    Time frame: 7 days

    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)

  3. operative time for complete excision of the sinus (minutes)

    Time frame: minutes (range 0-30 minutes)

    the operative time for complete excision was compared into the two group

Sponsors and collaborators

Lead sponsor

Ospedale di Cavalese

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 5, 2018
Registry last updated
Dec 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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