Clinical trial · Interventional
PILONIDAL SINUS: CONVENTIONAL CARE VERSUS NEGATIVE PRESSURE THERAPY.
RANDOMIZED COMPARATIVE CLINICAL STUDY BETWEEN TWO TREATMENT STRATEGIES IN PATIENTS WITH PILONIDAL SINUS: CONVENTIONAL CARE VERSUS NEGATIVE PRESSURE THERAPY.
- 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 Sinus PS is a prevalent disease in young patients. There is currently no consensus on the surgical treatment of choice. Each method is associated with different advantages and disadvantages, as well as different recurrence rates. The ideal treatment should reduce morbidity, be associated with a short hospital stay (outpatient surgery), promote rapid healing, early return to work, and have a low recurrence rate. To date, no technique meets all these criteria. However, the NPT could meet them. The use of NPT in PS could decrease healing time, achieving an early return to work. In addition, it would avoid the need for daily dressings, which would mean lower hospital costs. However, the location of the wound (sacrum) and its proximity to the anal margin mean that its use cannot be generalized. Although two retrospective series have recently reported good results with the use of NPT in PS, a prospective, randomized study is needed to compare healing time, recurrence rates, hospital costs, and assess quality of life for determine if this could be the treatment of choice. Although NPT is commonly used in clinical practice (being useful in closing complex wounds, with devitalized tissues, burns and wounds with exposed tendons), to date there is not enough evidence to support its use after flattening the PS and it is for this reason that we conducted this study. In this project there is a total absence of commercial interest in the proposal. No project related to the proposed one is currently being carried out.
Conditions
Conditions (2)
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 | — |
| Wound Heal | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional wound care | Other | — | UNRESOLVED |
| Negative pressure therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Conventional care
- interventionNames
- Other: Conventional wound care
- type
- EXPERIMENTAL
- label
- Negative pressure therapy
- interventionNames
- Device: Negative pressure therapy
Primary outcomes (1)
- measure
- Cicatrization
- timeFrame
- 1 year
- description
- Time in days from surgery to complete epithelialization of the wound, assessed by the dressing nurse and surgeon.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * All patients diagnosed with SP (recurrence or not), who have undergone surgery. * Minimum depth of the wound 1.5 cm. Exclusion Criteria: * Inferior margin of the surgical wound is located less than 3 cm from the anus * Patients under 16 years of age * Unable to track * Diagnosed psychiatric illness * Patients diagnosed with hidradenitis * Uncontrolled diabetics * Immunocompromised (kidney or liver transplant, chronic treatment with corticosteroids, haematological disease, neoplastic disease undergoing chemotherapy)
References
Publications (30)
- BACKGROUNDRoldon Golet M, Siles Hinojosa A, Gonzalez Ruiz Y, Escartin Villacampa R, Goded Broto I, Bragagnini Rodriguez P. Pilonidal sinus in adolescence: is there an ideal surgical approach? Cir Pediatr. 2021 Jul 1;34(3):119-124. English, Spanish. PMID 34254748
- BACKGROUNDKumar M, Clay WH, Lee MJ, Brown SR, Hind D. A mapping review of sacrococcygeal pilonidal sinus disease. Tech Coloproctol. 2021 Jun;25(6):675-682. doi: 10.1007/s10151-021-02432-9. Epub 2021 Mar 16. PMID 33728570
- BACKGROUNDCaliskan M, Kosmaz K, Subasi IE, Acar A, Evren I, Bas G, Atayoglu AT. Comparison of Common Surgical Procedures in Non-complicated Pilonidal Sinus Disease, a 7-Year Follow-Up Trial. World J Surg. 2020 Apr;44(4):1091-1098. doi: 10.1007/s00268-019-05331-1. PMID 31848678
- BACKGROUNDLuedi MM, Schober P, Stauffer VK, Diekmann M, Andereggen L, Doll D. Gender-specific prevalence of pilonidal sinus disease over time: A systematic review and meta-analysis. ANZ J Surg. 2021 Jul;91(7-8):1582-1587. doi: 10.1111/ans.16990. Epub 2021 Jun 7. PMID 34101331
- BACKGROUNDBi S, Sun K, Chen S, Gu J. Surgical procedures in the pilonidal sinus disease: a systematic review and network meta-analysis. Sci Rep. 2020 Aug 13;10(1):13720. doi: 10.1038/s41598-020-70641-7. PMID 32792519
- BACKGROUNDAl-Khamis A, McCallum I, King PM, Bruce J. Healing by primary versus secondary intention after surgical treatment for pilonidal sinus. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD006213. doi: 10.1002/14651858.CD006213.pub3. PMID 20091589
- BACKGROUNDGrabowski J, Oyetunji TA, Goldin AB, Baird R, Gosain A, Lal DR, Kawaguchi A, Downard C, Sola JE, Arthur LG, Shelton J, Diefenbach KA, Kelley-Quon LI, Williams RF, Ricca RL, Dasgupta R, St Peter SD, Somme S, Guner YS, Jancelewicz T. The management of pilonidal disease: A systematic review. J Pediatr Surg. 2019 Nov;54(11):2210-2221. doi: 10.1016/j.jpedsurg.2019.02.055. Epub 2019 Mar 19.