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

May 20, 2021 updated by: Mamaloudis Ioannis, Larissa University Hospital

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

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.

Study Overview

Status

Terminated

Conditions

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

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Larissa, Greece, 41110
        • University Hospital of Larissa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / 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

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

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
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

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2018

Primary Completion (Actual)

February 25, 2021

Study Completion (Actual)

April 25, 2021

Study Registration Dates

First Submitted

November 27, 2018

First Submitted That Met QC Criteria

November 28, 2018

First Posted (Actual)

November 29, 2018

Study Record Updates

Last Update Posted (Actual)

May 24, 2021

Last Update Submitted That Met QC Criteria

May 20, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • Pilonidal QoL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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