Pilonidal Cyst/FistulaNCT03757572
Alginate Dressings Versus Gauge Dressings After Pilonidal Cyst Resection: Examination of the Quality of Life
A study testing Alginate dressings and Simple gauze dressings in people with Pilonidal Cyst/Fistula, run by Larissa University Hospital at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pilonidal Cyst/Fistula
- What is being tested?
- Alginate dressings and Simple gauze dressings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteGreece
- Study dates
- 25 Dec 2018to 25 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pilonidal abscess
- Patient age ≥ 80 years or < 18 years
- Pilonidal abscess
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Pilonidal Cyst/Fistula
- Being tested
- Alginate dressings, Simple gauze dressings
- Keywords
- Pilonidal, Fistula, Cyst, Alginate, Gauze, Dressings, Prospective, Randomized Controlled Trial
- Medical subject headings
- Fistula, Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alginate dressingsOther
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 dressingsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Alginate dressings | Experimental | 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. Receives: Other: Alginate dressings |
| Simple gauze dressings | Active comparator | 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. Receives: Other: Simple gauze dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing time
Postoperative required time for wound healing. Measurement unit: days
Measured: Maximum time frame 50 days postoperatively
Secondary outcomes (15)
Postoperative return to everyday activities
Time required for returning to everyday activities. Measurement unit: days
Measured: Maximum time frame 50 days postoperatively
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.
Measured: 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
Measured: 7, 14, 21, 28, 35, 42 and 49 days postoperatively
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.
Measured: 50 days postoperatively
Cost of the material
Overall cost of the dressings applied
Measured: Maximum time frame 50 days postoperatively
Wound care visits
Number of required visits for postoperative wound care for each patient per week.
Measured: 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, then it will be defined as=0 'NO'
Measured: 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'
Measured: 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'
Measured: Maximum time frame 50 days postoperatively
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'
Measured: 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'
Measured: 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. 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.
Measured: 7, 14 and 21 days potoperatively
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.
Measured: 28 days postoperatively
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.
Measured: 35 days postoperatively
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.
Measured: 35 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start25 Dec 2018
- Primary completion25 Feb 2021
- Study completion25 Apr 2021
Why it stopped: Early termination due to COVID-19 pandemic. Suspension of elective case operations. Decreased recruitment rate. Inability to reach the estimated sample size.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Pilonidal Cyst/FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larissa University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Thessaly
- Responsible party
- Principal investigator, Mamaloudis Ioannis, Larissa University Hospital
- Investigators
- Ioannis Mamaloudis, Principal investigator, Department of Surgery, University Hospital of LarissaKonstantinos Tepetes, Study director, Department of Surgery, University Hospital of Larissa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757572
- Sponsor's protocol ID
- Pilonidal QoL
- Status last verified
- May 2021
- First submitted
- 27 Nov 2018
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
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.
PubMed 13111384BUIE LA, CURTISS RK. Pilonidal disease. Surg Clin North Am. 1952 Aug:1247-59. No abstract available.
PubMed 14950701Berry DP. Pilonidal sinus disease. J Wound Care. 1992 Sep 2;1(3):29-32. doi: 10.12968/jowc.1992.1.3.29.
PubMed 27911182Sondenaa 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.
PubMed 7745322Kronborg 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.
PubMed 3886069Sondenaa 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.
PubMed 12699097Karydakis 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.
PubMed 4128725Schultz 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.
PubMed 12654015Gruessner 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.
PubMed 11754859Lewis 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.
PubMed 11399237Armstrong 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.
PubMed 8080372Clothier PR, Haywood IR. The natural history of the post anal (pilonidal) sinus. Ann R Coll Surg Engl. 1984 May;66(3):201-3.
PubMed 6721409Blanco G, Giordano M, Torelli I. [Surgical treatment of pilonidal sinus with open surgical technique]. Minerva Chir. 2003 Apr;58(2):181-7. Italian.
PubMed 12738928Al-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.
PubMed 17902520Irkorucu 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.
PubMed 21956594
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03757572
- Acronym / sponsor ID
- Pilonidal QoL
- Conditions
- Pilonidal Cyst/Fistula
- Keywords
- Pilonidal, Fistula, Cyst, Alginate, Gauze, Dressings, Prospective, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination due to COVID-19 pandemic. Suspension of elective case operations. Decreased recruitment rate. Inability to reach the estimated sample size.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Collaborators
- University of Thessaly
- Study start
- 25 Dec 2018 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 25 Apr 2021 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alginate dressings | Experimental | Other: Alginate dressingsThe 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. |
| Simple gauze dressings | Active comparator | Other: Simple gauze dressingsThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Pilonidal abscess
- Patient age ≥ 80 years or < 18 years
- Pilonidal abscess
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alginate dressingsThe 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. | Other | Alginate dressings |
| Simple gauze dressingsThe 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. | Other | Simple gauze dressings |
Primary outcome
Wound healing time
Time frame: Maximum time frame 50 days postoperatively
Postoperative required time for wound healing. Measurement unit: days
15 secondary outcomes
Postoperative return to everyday activities
Time frame: Maximum time frame 50 days postoperatively
Postoperative pain level
Time frame: 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
Overall satisfaction level
Time frame: 50 days postoperatively
Cost of the material
Time frame: Maximum time frame 50 days postoperatively
Wound care visits
Time frame: 7, 14, 21, 28, 35, 42 and 49 days postoperatively
Trauma secretions
Time frame: 7, 14, 21, 28, 35, 42 and 49 days postoperatively
Wound contamination
Time frame: Maximum time frame 50 days postoperatively
Wound erythema
Time frame: Maximum time frame 50 days postoperatively
Wound haematoma
Time frame: Maximum time frame 50 days postoperatively
Disease recurrence
Time frame: Maximum time frame 1 year postoperatively
Difference in the quality of life of the patient
Time frame: 7, 14 and 21 days potoperatively
Medium term quality of life
Time frame: 28 days postoperatively
Treatment satisfaction
Time frame: 35 days postoperatively
Treatment acceptance
Time frame: 35 days postoperatively
Results and safety
The study was stopped early (reason given: Early termination due to COVID-19 pandemic. Suspension of elective case operations. Decreased recruitment rate. Inability to reach the estimated sample size.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Background: PubMed 13111384DWIGHT 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.
- Background: PubMed 14950701BUIE LA, CURTISS RK. Pilonidal disease. Surg Clin North Am. 1952 Aug:1247-59. No abstract available.
- Background: PubMed 27911182Berry DP. Pilonidal sinus disease. J Wound Care. 1992 Sep 2;1(3):29-32. doi: 10.12968/jowc.1992.1.3.29.
- Background: PubMed 7745322Sondenaa 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.
- Background: PubMed 3886069Kronborg 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.
- Background: PubMed 12699097Sondenaa 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.
- Background: PubMed 4128725Karydakis 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.
- Background: PubMed 12654015Schultz 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.
- Background: PubMed 11754859Gruessner 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.
- Background: PubMed 11399237Lewis 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.
- Background: PubMed 8080372Armstrong 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.
- Background: PubMed 6721409Clothier PR, Haywood IR. The natural history of the post anal (pilonidal) sinus. Ann R Coll Surg Engl. 1984 May;66(3):201-3.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ioannis Mamaloudis principal investigator
Department of Surgery, University Hospital of Larissa
Konstantinos Tepetes study director
Department of Surgery, University Hospital of Larissa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alginate dressings and Simple gauze dressings in people with Pilonidal Cyst/Fistula, run by Larissa University Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Early termination due to COVID-19 pandemic. Suspension of elective case operations. Decreased recruitment rate. Inability to reach the estimated sample size.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing time (time frame: Maximum time frame 50 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03757572, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.