Clinical trial · Observational
Pilonidal Sinus Disease: Preliminare Study
Pilonidal Sinus Disease: Preliminary Case-control Study on Heat-related Wound Dehiscence
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pilonidal Sinus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| in "Cold" group 13 patients were treated by scalpel. | Procedure | — | UNRESOLVED |
| In "hot" group 16 patients were treated by diathermy in "Cold" | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 16 patients, named "Hot" group
- description
- We considered 16 sinus excision by diathermy as a case group (named "Hot" group)
- interventionNames
- Procedure: In "hot" group 16 patients were treated by diathermy in "Cold"
- Procedure: in "Cold" group 13 patients were treated by scalpel.
- label
- 13 patients, named "Cold group"
- description
- 13 procedures performed by knife as control group (named "Cold" group).
- interventionNames
- Procedure: In "hot" group 16 patients were treated by diathermy in "Cold"
- Procedure: in "Cold" group 13 patients were treated by scalpel.
Primary outcomes (1)
- measure
- Number of complete wound healed and not healed after 8 postoperative days
- timeFrame
- Up to 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 52 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDGiuseppe 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. PMID 31890195