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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Pilonidal cyst was first described by Hodges in 1880. The disease of pilonidal cyst is also known as "Jeep disease", due to the fact that, during World War II (1941-1945), several American soldiers (about 80,000) suffered from this disease, because, either they were driving for long hours on uneven, destroyed by war, roads, or, they were spending time sitting at military vehicles like jeep, trucks and tankers, resulting in being submitted to surgical operation, in order to alleviate the arousing pilonidal cyst problem, at USA military hospitals.
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.
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Larissa, Greece, 41110
- University Hospital of Larissa
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: 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. |
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. |
|
Active Comparator: 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. |
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. |
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wound healing time
Time Frame: Maximum time frame 50 days postoperatively
|
Postoperative required time for wound healing.
Measurement unit: days
|
Maximum time frame 50 days postoperatively
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative return to everyday activities
Time Frame: Maximum time frame 50 days postoperatively
|
Time required for returning to everyday activities.
Measurement unit: days
|
Maximum time frame 50 days postoperatively
|
|
Postoperative pain level
Time Frame: 7, 14, 21, 28, 35, 42 and 49 days postoperatively
|
Pain level after surgery, quantified with the use of the Visual Analogue Scale (0-10).
Better outcome: 0, Worse outcome: 10.
There will be no subscales or total scores.
|
7, 14, 21, 28, 35, 42 and 49 days postoperatively
|
|
Postoperative analgesics consumption
Time Frame: 7, 14, 21, 28, 35, 42 and 49 days postoperatively
|
Number of analgesic pills consumed per day after surgery.
Measurement unit: pills per day
|
7, 14, 21, 28, 35, 42 and 49 days postoperatively
|
|
Overall satisfaction level
Time Frame: 50 days postoperatively
|
Satisfaction level after surgery, quantified with the use of the Visual Analogue Scale (0-10).
Better outcome: 10, Worse outcome: 0. There will be no subscales or total scores.
|
50 days postoperatively
|
|
Cost of the material
Time Frame: Maximum time frame 50 days postoperatively
|
Overall cost of the dressings applied
|
Maximum time frame 50 days postoperatively
|
|
Wound care visits
Time Frame: 7, 14, 21, 28, 35, 42 and 49 days postoperatively
|
Number of required visits for postoperative wound care for each patient per week.
|
7, 14, 21, 28, 35, 42 and 49 days postoperatively
|
|
Trauma secretions
Time Frame: 7, 14, 21, 28, 35, 42 and 49 days postoperatively
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Trauma secretions leading to extra dressing care.
If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
|
7, 14, 21, 28, 35, 42 and 49 days postoperatively
|
|
Wound contamination
Time Frame: Maximum time frame 50 days postoperatively
|
Contamination of the wound trauma.
If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
|
Maximum time frame 50 days postoperatively
|
|
Wound erythema
Time Frame: Maximum time frame 50 days postoperatively
|
Erythema of the wound.
If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
|
Maximum time frame 50 days postoperatively
|
|
Wound haematoma
Time Frame: Maximum time frame 50 days postoperatively
|
Haematoma of the wound.
If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
|
Maximum time frame 50 days postoperatively
|
|
Disease recurrence
Time Frame: Maximum time frame 1 year postoperatively
|
Disease recurrence rate.
If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
|
Maximum time frame 1 year postoperatively
|
|
Difference in the quality of life of the patient
Time Frame: 7, 14 and 21 days potoperatively
|
Difference in the quality of life of the patient based on the Quality of Life with Chronic Wounds Wounds (Qol) Questionnaire. 17 items in total. Each item quantified with the use of a Visual Ordinal Scale (0='not at all' to 4='very much'). Global score computed by averaging all items. In total 3 subscales calculated by averaging the respective items: Body: Items #1 to #5. Psyche: Items #6 to #10. Everyday life: Items #11 to #16. |
7, 14 and 21 days potoperatively
|
|
Medium term quality of life
Time Frame: 28 days postoperatively
|
Quality of life of the patient based on the Short Form 36 (SF-36) questionnaire. 36 items in total. The following ordinal scales will be used for the respective items: 1 (Better)-5 (Worse): #1, #2, #20, #22, #34, #36. 1 (Worse)-3 (Better): #3, to #12. 1 (Worse)-2 (Better): #13, to #19. 1 (Better)-6 (Worse): #21, #23, #26, #27, #30. 1 (Worse)-6 (Better): #24, #25, #28, #29, #31. 1 (Worse)-5 (Better): #32, #33, #35. In total 8 subscales calculated by averaging the respective items. Physical functioning: #3 to #12. Role limitations due to physical health: #13 to #16. Role limitations due to emotional problems: #17 to #19. Energy/fatigue: #23, #27, #29, #31. Emotional well-being: #24 to #26, #28, #30. Social functioning: #20, #32. Pain: #21, #22. General health: #1, #33 to #36. |
28 days postoperatively
|
|
Treatment satisfaction
Time Frame: 35 days postoperatively
|
Patient satisfaction regarding the treatment quantified with the use of a Visual Ordinal Scale (1-5).
Better outcome: 5, Worse outcome: 1.
There will be no subscales or total scores.
|
35 days postoperatively
|
|
Treatment acceptance
Time Frame: 35 days postoperatively
|
Patient acceptance regarding the re-application of the treatment quantified with the use of a Visual Ordinal Scale (1-5).
Better outcome: 5, Worse outcome: 1.
There will be no subscales or total scores.
|
35 days postoperatively
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Ioannis Mamaloudis, Department of Surgery, University Hospital of Larissa
- Study Director: Konstantinos Tepetes, Department of Surgery, University Hospital of Larissa
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- Pilonidal QoL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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