Clinical trial NCT03757572: Alginate Dressings Versus Gauge Dressings After Pilonidal Cyst Resection: Examination of the Quality of Life
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pilonidal Cyst/Fistula
Keywords: Pilonidal
Fistula
Cyst
Alginate
Gauze
Dressings
Prospective
Randomized Controlled Trial
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
Collaborators: name: University of Thessaly
First posted: 2018-11-29
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Wound healing time
timeFrame: Maximum time frame 50 days postoperatively
Secondary outcomes:
measure: Postoperative return to everyday activities
timeFrame: Maximum time frame 50 days postoperatively
measure: Postoperative pain level
timeFrame: 7, 14, 21, 28, 35, 42 and 49 days postoperatively
measure: Postoperative analgesics consumption
timeFrame: 7, 14, 21, 28, 35, 42 and 49 days postoperatively
measure: Overall satisfaction level
timeFrame: 50 days postoperatively
measure: Cost of the material
timeFrame: Maximum time frame 50 days postoperatively
measure: Wound care visits
timeFrame: 7, 14, 21, 28, 35, 42 and 49 days postoperatively
measure: Trauma secretions
timeFrame: 7, 14, 21, 28, 35, 42 and 49 days postoperatively
measure: Wound contamination
timeFrame: Maximum time frame 50 days postoperatively
measure: Wound erythema
timeFrame: Maximum time frame 50 days postoperatively
measure: Wound haematoma
timeFrame: Maximum time frame 50 days postoperatively
measure: Disease recurrence
timeFrame: Maximum time frame 1 year postoperatively
measure: Difference in the quality of life of the patient
timeFrame: 7, 14 and 21 days potoperatively
measure: Medium term quality of life
timeFrame: 28 days postoperatively
measure: Treatment satisfaction
timeFrame: 35 days postoperatively
measure: Treatment acceptance
timeFrame: 35 days postoperatively
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University Hospital of Larissa
Study officials:
affiliation: Department of Surgery, University Hospital of Larissa
name: Ioannis Mamaloudis
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery, University Hospital of Larissa
name: Konstantinos Tepetes
role: STUDY_DIRECTOR
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