Alginate Dressings Versus Gauge Dressings After Pilonidal Cyst Resection: Examination of the Quality of Life
NCT ID: NCT03757572
Last Updated: 2021-05-24
Study Results
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Basic Information
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TERMINATED
NA
65 participants
INTERVENTIONAL
2018-12-25
2021-04-25
Brief Summary
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Detailed Description
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Pilonidal cyst, is considered as one of the most common diseases of the subcutaneous tissues of the sacrococcygeal region. This situation is the result of hair penetrating into the skin, a situation not uncommon in this anatomical area. In a study including 50,000 college students, pilonidal cyst occurrence, in males, was 1.1%, which was 10 times higher compared to females, although a considerable rate of them was asymptomatic. Evidence from studies in England, also, indicate that the disease is more frequent in men than women (1 to 3) . The disease is more common in Caucasians than in Asians or Africans due to the differences in their hair characteristics and the respective hair development pattern. Risk factors include the following: sedentary life (44%), positive family history (38%), obesity (50%) and regional irritation (34%). The disease usually presents during the age of 16 - 20 and prevalence is decreasing drastically after the 25th year of age. This disease rarely develops before the adolescence and after the 40th year of age.
Treatment usually depends on the condition of the disease. An acute abscess is usually controlled with incision and drainage. A chronic pilonidal cyst is best treated with a surgical procedure that involves complete resection of the cyst along with the coexisting fistulas, in order to ensure the minimum reoccurrence rate. There are two choices after surgical resection, secondary intention wound healing or primary trauma closure, with or without a flap. The surgical procedure can be performed with the administration of local anaesthesia in the outpatient office or in a day-clinic, or with the use of general anaesthesia depending on the condition of the patient.
Post operatively secondary intention wound healing is applied in many cases, especially when factors like infection, necrotic tissue or inflammatory tissue are introduced. There are many dressings that can be used for the care of a surgical trauma. The ideal dressing used should have some special characteristics such as absorption of exudates without leakage, provision of a dry environment that prevents bacteria from entering the wound and facilitation of easy appliance, as well as removal. Choosing the right dressing is not based on a certain protocol, but mostly on the surgeon preference.
The current study aims at comparing two groups of patients that will be subjected to surgical resection of pilonidal cyst and secondary intention wound healing. In the first group, dressings like alginate cord with silver and high G cellulose will be used for filling of the wound cavity and a hydro-capillary dressing for sealing and waterproofing the wound. In the other group, simple gauze dressings for the coverage of the wound cavity will be used. Comparison of the two groups will involve all the endpoints that indicate whether such dressings can facilitate faster wound healing, enabling, thus, patients to faster return to their everyday activities. Furthermore, a parameter that has not been, previously, studied, the quality of life after the surgical excision of the pilonidal cyst, by using the SF - 36 and the Quality of life with Chronic Wound questionnaire, will, also, be investigated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Alginate dressings
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.
Alginate dressings
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 will be applied to the wound. 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, will be also placed.
During wound care the wound will be irrigated with normal saline and betadine solution and finally without pressure the trauma will be dried.
Simple gauze dressings
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.
Simple gauze dressings
The pilonidal cyst will be resected, with the use of a scalpel and then haemostasis will be performed with diathermy. Simple gauze dressings will be applied to the wound.
During wound care the wound will be irrigated with normal saline and betadine solution and finally without pressure the trauma will be dried.
Interventions
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Alginate dressings
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 will be applied to the wound. 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, will be also placed.
During wound care the wound will be irrigated with normal saline and betadine solution and finally without pressure the trauma will be dried.
Simple gauze dressings
The pilonidal cyst will be resected, with the use of a scalpel and then haemostasis will be performed with diathermy. Simple gauze dressings will be applied to the wound.
During wound care the wound will be irrigated with normal saline and betadine solution and finally without pressure the trauma will be dried.
Eligibility Criteria
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Inclusion Criteria
* 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
* Patient age ≥ 80 years or \< 18 years
* Pilonidal abscess
18 Years
80 Years
ALL
No
Sponsors
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University of Thessaly
OTHER
Larissa University Hospital
OTHER
Responsible Party
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Mamaloudis Ioannis
Principal Investigator
Principal Investigators
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Ioannis Mamaloudis
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, University Hospital of Larissa
Konstantinos Tepetes
Role: STUDY_DIRECTOR
Department of Surgery, University Hospital of Larissa
Locations
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University Hospital of Larissa
Larissa, , Greece
Countries
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References
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DWIGHT 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.
BUIE LA, CURTISS RK. Pilonidal disease. Surg Clin North Am. 1952 Aug:1247-59. No abstract available.
Berry DP. Pilonidal sinus disease. J Wound Care. 1992 Sep 2;1(3):29-32. doi: 10.12968/jowc.1992.1.3.29.
Sondenaa 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.
Kronborg 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.
Sondenaa 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.
Karydakis 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.
Schultz 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.
Gruessner U, Clemens M, Pahlplatz PV, Sperling P, Witte J, Rosen HR; Septocoll Study Group. Improvement of perineal wound healing by local administration of gentamicin-impregnated collagen fleeces after abdominoperineal excision of rectal cancer. Am J Surg. 2001 Nov;182(5):502-9. doi: 10.1016/s0002-9610(01)00762-0.
Lewis R, Whiting P, ter Riet G, O'Meara S, Glanville J. A rapid and systematic review of the clinical effectiveness and cost-effectiveness of debriding agents in treating surgical wounds healing by secondary intention. Health Technol Assess. 2001;5(14):1-131. doi: 10.3310/hta5140.
Armstrong JH, Barcia PJ. Pilonidal sinus disease. The conservative approach. Arch Surg. 1994 Sep;129(9):914-7; discussion 917-9. doi: 10.1001/archsurg.1994.01420330028006.
Clothier PR, Haywood IR. The natural history of the post anal (pilonidal) sinus. Ann R Coll Surg Engl. 1984 May;66(3):201-3.
Blanco G, Giordano M, Torelli I. [Surgical treatment of pilonidal sinus with open surgical technique]. Minerva Chir. 2003 Apr;58(2):181-7. Italian.
Al-Salamah SM, Hussain MI, Mirza SM. Excision with or without primary closure for pilonidal sinus disease. J Pak Med Assoc. 2007 Aug;57(8):388-91.
Irkorucu O, Erdem H, Reyhan E. The best therapy for pilonidal disease: which management for which type? World J Surg. 2012 Mar;36(3):691-2. doi: 10.1007/s00268-011-1285-2. No abstract available.
Anagnostopoulos F, Niakas D, Pappa E. Construct validation of the Greek SF-36 Health Survey. Qual Life Res. 2005 Oct;14(8):1959-65. doi: 10.1007/s11136-005-3866-8.
Blome C, Baade K, Debus ES, Price P, Augustin M. The "Wound-QoL": a short questionnaire measuring quality of life in patients with chronic wounds based on three established disease-specific instruments. Wound Repair Regen. 2014 Jul-Aug;22(4):504-14. doi: 10.1111/wrr.12193.
Deutsch CJ, Edwards DM, Myers S. Wound dressings. Br J Hosp Med (Lond). 2017 Jul 2;78(7):C103-C109. doi: 10.12968/hmed.2017.78.7.C103. No abstract available.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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Pilonidal QoL
Identifier Type: -
Identifier Source: org_study_id
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