Clinical trial · Interventional
Alginate Dressings Versus Gauge Dressings After Pilonidal Cyst Resection: Examination of the Quality of Life
Secondary Intention Wound Healing, in Patients Subjected to Surgical Resection of Pilonidal Cyst, Using Alginate Dressings With Silver and High-G Cellulose, Compared to the Use of Simple Gauze Dressings: Examination of the Quality of Life
NCT03757572CI-TRIAL-00051950terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Early termination due to COVID-19 pandemic. Suspension of elective case operations. Decreased recruitment rate. Inability to reach the estimated sample size.
Summary
Brief summary (as posted)
The purpose of this study is to compare the application of alginate dressings with silver and high-G cellulose and the use of simple gauge dressings in patients submitted to surgical resection of pilonidal cyst. The present trial will focus on the postoperative quality of life during the secondary intention wound healing.
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 Cyst/Fistula | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alginate dressings | Other | — | UNRESOLVED |
| Simple gauze dressings | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Alginate dressings
- description
- The pilonidal cyst will be resected, with the use of a scalpel and then haemostasis will be performed with diathermy. Alginate dressings with silver and high-G cellulose, which combine increased absorption properties, antimicrobial action and high coherence will be used. The size of the dressings will be 3cm X 45cm and 1 cm cord will be used for filling the wound cavity. Dressings with perimetric adhesive layer from natural materials for latent breathing of the skin with dressing dimensions based on the wound size, will be also placed. Wound care will be performed in a specific way each time that the dressings will be removed. The wound will be irrigated with normal saline and betadine solution and finally without pressure the trauma will be dried.
- interventionNames
- Other: Alginate dressings
- type
- ACTIVE_COMPARATOR
- label
- Simple gauze dressings
- description
- The pilonidal cyst will be resected, with the use of a scalpel and then haemostasis will be performed with diathermy. Wound care will be performed with the application of simple gauze dressings. Wound care will be performed in a specific way each time that the dressings will be removed. The wound will be irrigated with normal saline and betadine solution and finally without pressure the trauma will be dried.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female * Pilonidal cyst * Age: 18 to 80 years * American Society of Anesthesiologists (ASA) score: I, II, III, IV * Disease stage I,II,III and IV Exclusion Criteria: * Pilonidal abscess * Patient age ≥ 80 years or \< 18 years * Pilonidal abscess
References
Publications (18)
- BACKGROUNDDWIGHT RW, MALOY JK. Pilonidal sinus; experience with 449 cases. N Engl J Med. 1953 Dec 3;249(23):926-30. doi: 10.1056/NEJM195312032492303. No abstract available. PMID 13111384
- BACKGROUNDBUIE LA, CURTISS RK. Pilonidal disease. Surg Clin North Am. 1952 Aug:1247-59. No abstract available. PMID 14950701
- BACKGROUNDBerry DP. Pilonidal sinus disease. J Wound Care. 1992 Sep 2;1(3):29-32. doi: 10.12968/jowc.1992.1.3.29. PMID 27911182
- BACKGROUNDSondenaa K, Andersen E, Nesvik I, Soreide JA. Patient characteristics and symptoms in chronic pilonidal sinus disease. Int J Colorectal Dis. 1995;10(1):39-42. doi: 10.1007/BF00337585. PMID 7745322
- BACKGROUNDKronborg O, Christensen K, Zimmermann-Nielsen C. Chronic pilonidal disease: a randomized trial with a complete 3-year follow-up. Br J Surg. 1985 Apr;72(4):303-4. doi: 10.1002/bjs.1800720418. PMID 3886069
- BACKGROUNDSondenaa K, Diab R, Nesvik I, Gullaksen FP, Kristiansen RM, Saebo A, Komer H. Influence of failure of primary wound healing on subsequent recurrence of pilonidal sinus. combined prospective study and randomised controlled trial. Eur J Surg. 2002;168(11):614-8. doi: 10.1080/11024150201680007. PMID 12699097
- BACKGROUNDKarydakis GE. New approach to the problem of pilonidal sinus. Lancet. 1973 Dec 22;2(7843):1414-5. doi: 10.1016/s0140-6736(73)92803-1. No abstract available. PMID 4128725
- BACKGROUNDSchultz GS, Sibbald RG, Falanga V, Ayello EA, Dowsett C, Harding K, Romanelli M, Stacey MC, Teot L, Vanscheidt W. Wound bed preparation: a systematic approach to wound management. Wound Repair Regen. 2003 Mar;11 Suppl 1:S1-28. doi: 10.1046/j.1524-475x.11.s2.1.x.