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
Phase: NA
Conditions: Pilonidal Cyst/Fistula
Sponsor: Larissa University Hospital

COVER PAGE 
Research Protocol
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.
BRIEF TITLE: Alginate Dressings Versus Gauge Dressings After Pilonidal Cyst 
Resection: Examination of the Quality of Life
UNIQUE PROTOCOL ID: Pilonidal QoL
DOCUMENT DATE: November 27, 2018 
Principal Investigator:
Ioannis Mamaloudis 
Telephone: 00306977787592
Email: imamaloudis@yahoo.gr
Sub-Investigators:
Konstantinos Perivoliotis
Christos Zlatanos
Evangelia Kouvata
Study Director
Konstantinos Tepetes, Professor of General Surgery
Telephone: 00302413502804
Email: tepetesk@gmail.com
Department of Surgery
University Hospital of Larissa
Mezourlo 41110 Larissa
Greece

CHAPTER 1
INTRODUCTION
Pilonidal cyst was first described by Hodges in 18801 .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 females2, 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)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 pattern4. Risk factors include the 
following:  sedentary life (44%), positive family history (38%), obesity (50%) and 
regional irritation (34%)5. 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 age6 .
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 rate7. There are two 
choices  after  surgical  resection,  secondary  intention  wound  healing8 or  primary 
trauma closure, with or without a flap9,10 .  The surgical procedure can be performed 
with the administration of local anesthesia in the outpatient office or in a day-clinic, 
or with the use of general anesthesia 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 
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introduced11 . 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 12. Choosing the right dressing is not based on a certain protocol, but mostly 
on the surgeon preference13-18.
In the current study our objective is the comparison between different wound 
dressings and how they can affect secondary intention wound healing in patients that 
have been subjected to surgical resection of pilonidal cyst. Emphasis will be given at 
the postoperative quality of life of these patients.
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CHAPTER 2
OBJECTIVE
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 hydrocapillary 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.  
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CHAPTER 3
MATERIALS AND METHODS
1. Estimation of the necessary study sample size
According to literature, the mean time required for wound healing of patients 
subjected to pilonidal cyst resection is 60.4 ±6.2 days14. Therefore for a 5% decrease 
in the duration of the healing process and with an 1:1 enrollment ratio between the 
two groups, with alpha 0,05 and 90% power, the required number of patients in each 
group is 89. The total amount of patients required for completion of the study is 178. 
Patients that will not complete follow-up will be excluded and replaced by other 
patients.
2. Disease staging system
Pilonidal cyst will be staged according to the following classification system.
Type I Pit(s) on the natal cleft 
        IA Asymptomatic one or more pit(s) on the natal cleft without a history of 
abscess
             IB   Symptomatic and / or more than one pit on the natal cleft
Type  II   Pit(s) on either side of the natal cleft
           IIA Distance from the natal cleft < 2.5 cm
           IIB Distance from the natal cleft > 2.5 cm
Type   III  Pits on both side of the natal cleft
Type   IV  Recurrent pilonidal disease
3. 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
4. Exclusion Criteria

Pilonidal abscess

Patient age ≥ 80 years or < 18 years
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
Pilonidal abscess
5. Randomization
The randomization of the patients, between the two groups, will be performed using a 
software and a 1: 1 allocation ratio will be performed. Furthermore, an opaque 
envelope, which will contain the allocation group for the specific patient, will be 
opened preoperatively upon the entry of the patient into the surgical room.
6. Blinding
Blinding will exist at the level of the investigator who will record the data 
postoperatively. There will be no blinding at the level of the surgeon or the patient.
7. Endpoints
Primary Outcome Measure:
Wound healing time. Postoperative required time for wound healing. Measurement 
unit: days. [Time Frame: Maximum time frame 50 days postoperatively]
Secondary Outcome Measures:
Postoperative return to everyday activities. Time required for returning to everyday 
activities. Measurement unit: days [Time Frame: Maximum time frame 50 days 
postoperatively]
Postoperative pain level. Pain level after surgery, quantified with the use of the VAS 
scale. [Time Frame: 7, 14, 21, 28, 35, 42 and 49 days postoperatively]
Postoperative analgesics consumption. Number of analgesic pills consumed per day 
after surgery. Measurement unit: pills per day [Time Frame: 7, 14, 21, 28, 35, 42 
and 49 days postoperatively]
Overall satisfaction level. Satisfaction level measured at a 0-10 scale [Time Frame: 
50 days postoperatively]
Cost of the material. Overall cost of the dressings applied [Time Frame: Maximum 
time frame 50 days postoperatively]
Wound care visits. Number of required visits for postoperative wound care for each 
patient per week.[Time Frame: 7, 14, 21, 28, 35, 42 and 49 days postoperatively]
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, 
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then it will be defined as=0 'NO' [Time Frame: 7, 14, 21, 28, 35, 42 and 49 days 
postoperatively]
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' [Time Frame: Maximum time frame 50 days 
postoperatively]
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' [Time Frame: Maximum time frame 50 days postoperatively]
Wound hematoma. Hematoma 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'[Time Frame: Maximum time frame 50 days postoperatively]
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' [Time Frame: Maximum time frame 1 year postoperatively]
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 [Time Frame: 7, 14 and 21 days postoperatively]
Medium term quality of life. Quality of life of the patient based on the Short Form 
36 (SF-36) questionnaire [Time Frame: 28 days postoperatively]
Treatment satisfaction. Patient satisfaction regarding the treatment results measured 
at a 1-5 scale [Time Frame: 35 days postoperatively]
Treatment acceptance. Patient acceptance regarding the re-application of the 
treatment measured at a 1-5 scale [Time Frame: 35 days postoperatively]
8. Experimental Group
The pilonidal cyst will be resected, with the use of a scalpel and then hemostasis 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.
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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.
9. Active Comparator
The pilonidal cyst will be resected, with the use of a scalpel and then hemostasis 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.
10. The questionnaires used for evaluation of the patients quality of life 
participating in this study.
Two questionnaires will be used, SF-36 and Quality of life with Chronic Wound. The 
first one will be the Greek version of the questionnaire and the second one will be in 
the original English version and will be answered by patients that have the necessary 
knowledge of the English language. SF-36 will be answered from the patients every 
four weeks.  Quality of life with Chronic Wound will be answered every seven days 
by phone or during reevaluation. 
11. Consent Form.
Every patient will sign preoperatively a consent form agreeing to participate in the 
study after being informed. 
12. Trial.
The  present  non-commercial  prospective  randomized  controlled  study  will  be 
conducted in the Department of Surgery of the University Hospital of Larissa. Patient 
data will be recorded both in the patient charts and in an electronic database.  The 
hospital  will  not  be  addressed  with  any  form  of  economic  burden.  There will 
be no form of financial support for the present study.
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