Alginate Dressings Versus Gauge Dressings After Pilonidal Cyst Resection: Examination of the Quality of Life

Pilonidal Cyst/Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03757572
• Other study ID #: Pilonidal QoL
• Status: Terminated
• Phase: N/A
• Start date: December 25, 2018
• Est. completion date: April 25, 2021

Study information

• Verified date: May 2021
• Source: Larissa University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: April 25, 2021
• Est. primary completion date: February 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cysts
• Fistula
• Pilonidal Cyst/Fistula
• Pilonidal Sinus

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Greece	University Hospital of Larissa	Larissa

Sponsors (2)

Lead Sponsor	Collaborator
Larissa University Hospital	University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (18)

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Armstrong JH, Barcia PJ. Pilonidal sinus disease. The conservative approach. Arch Surg. 1994 Sep;129(9):914-7; discussion 917-9. — View Citation

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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. — View Citation

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Clothier PR, Haywood IR. The natural history of the post anal (pilonidal) sinus. Ann R Coll Surg Engl. 1984 May;66(3):201-3. — View Citation

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Søndenaa K, Diab R, Nesvik I, Gullaksen FP, Kristiansen RM, Saebø A, Kømer 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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing time	Postoperative required time for wound healing. Measurement unit: days	Maximum time frame 50 days postoperatively
Secondary	Postoperative return to everyday activities	Time required for returning to everyday activities. Measurement unit: days	Maximum time frame 50 days postoperatively
Secondary	Postoperative pain level	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
Secondary	Postoperative analgesics consumption	Number of analgesic pills consumed per day after surgery. Measurement unit: pills per day	7, 14, 21, 28, 35, 42 and 49 days postoperatively
Secondary	Overall satisfaction level	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
Secondary	Cost of the material	Overall cost of the dressings applied	Maximum time frame 50 days postoperatively
Secondary	Wound care visits	Number of required visits for postoperative wound care for each patient per week.	7, 14, 21, 28, 35, 42 and 49 days postoperatively
Secondary	Trauma secretions	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
Secondary	Wound contamination	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
Secondary	Wound erythema	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
Secondary	Wound haematoma	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
Secondary	Disease recurrence	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
Secondary	Difference in the quality of life of the patient	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
Secondary	Medium term quality of life	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
Secondary	Treatment satisfaction	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
Secondary	Treatment acceptance	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