Pilonidal Sinus InfectedNCT06152952
Rhomboid Flap vs. Deep Suturing in Recurrent Pilonidal Sinus
An observational study of Pilonidal Sinus Infected, run by Assiut University.
Trial summary
This prospective clinical trial aims to compare the perioperative outcomes of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pilonidal Sinus Infected
- What is being tested?
- The rhomboid flap approach
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Jan 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 60 years
- All sexes
- Adult
Study population: Diversity in population, some come from a rural environment and others from the city
Who may be able to join
- Adult patients aged between 18 and 60 years;
- Patients with one or two small inactive sinuses will be included for easier excisional procedures;
- Previous intervention for pilonidal disease whether surgical or non-surgical;
Who cannot join
- 1 - Patients with an acute abscess. 2- Patients with mall inactive pilonidal sinus disease. 3- Age beyond the previous limits. 4- Patients with primary pilonidal disease. 5- Refusal to participate in the study. 6- Unfit for anaesthesia and surgery. 7- Patients with malignant neoplasms or inflammatory bowel disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Rhomboid Flap Outcome in the Surgical Treatment of Recurrent Sacrococcygeal Pilonidal Sinus vs. Deep Suturing
This prospective clinical trial aims to compare the perioperative outcomes of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease.
Read the detailed description
Pilonidal disease derives its name from Latin- pilus meaning "hair," and nidus meaning "nest" . The source of pilonidal disease is thought to be a deep intergluteal sulcus. It is widely accepted that the establishment of the pilonidal sinus results from the penetration of shed hair shafts through the skin, which ultimately leads to an acute or chronic infected site .
Pilonidal disease is largely considered a surgical disease, especially in acute instances with secondary infection and abscess. Infection or abscess requires incision and drainage. Definitive treatment is delayed the majority of the time if there is an acute infection or abscess until after the infection has been addressed. Surgical options for chronic disease are numerous and can include "pit picking," curettage, aspiration, unroofing, or surgical excision. Defects can be closed primarily, with flaps or grafts, or allowed to heal by secondary intention .
The most serious problem of the various surgical approaches proposed is the recurrence rate, ranging from 0% to 40% .
The surgical treatment of patients with recurrent disease does not differ from the surgical treatment of primary pilonidal disease. In case of a recurrence with an abscess, incision and drainage prevail, while in case of chronic recurrent disease, a flap based procedure may be indicated following sinus excision with scarring, like the rhomboid flap .
- Conditions
- Pilonidal Sinus Infected
- Being tested
- The rhomboid flap approach
- Keywords
- Rhomboid flap, Deep suturing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The rhomboid flap approachProcedure or surgery
Also called The deep suturing approach
The rhomboid flap Approach :
The flap will be dissected deep to the gluteal fascia (subfascial level) so as to raise thick a fasciocutaneous flap. This will assure good vascularity of the flap without dead space. The rhomboid flap (CDEF) will be mobilized from the gluteal fascia and sutured without tension in three layers
The deep suturing approach :
A vertical elliptical incision encompassing all pilonidal pits will be made and excision of the sinus will be carried out down to the level of the sacrococcygeal fascia. T then the deep fascia will be approximated and the wound will be closed
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : The rhomboid flap Approach | The flap will be dissected deep to the gluteal fascia (subfascial level) so as to raise thick a fasciocutaneous flap. This will assure good vascularity of the flap without dead space. The rhomboid flap (CDEF) will be mobilized from the gluteal fascia and sutured without tension in three layers (gluteal fascia with 2/0 Vicryl, subcutaneous fat with 3/0 Vicryl, and the skin with 4/0 Prolene). As all sides will be equal in length, the flap fits in place without tension. A suction drain will be left behind and the wound will be dressed as usual. Pressure wound dressing will be applied and removed on the third postoperative day. Receives: Procedure: The rhomboid flap approach | |
| Group 2 : The deep suturing approach | A vertical elliptical incision encompassing all pilonidal pits will be made and excision of the sinus will be carried out down to the level of the sacrococcygeal fascia. Tension will be released by a limited sharp dissection above the fascia. After haemostasis is ensured using electrocautery, a suction drain will be inserted through a separate incision, then the deep fascia will be approximated and the wound will be closed in layers using polyglactin 0 sutures. Finally, the skin will be closed with 2/0 polypropylene interrupted mattress sutures. Receives: Procedure: The rhomboid flap approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome of comparing the perioperative of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease.
Primary Outcome :
Postoperative recurrence rate. Recurrence will be defined as the additional outbreak of signs and symptoms of pilonidal disease after a disease-free interval following complete wound healing
Measured: baseline
Secondary outcomes (1)
Secondary Outcome (subsidiary)of comparing the perioperative of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease.
Secondary Outcome (subsidiary):
- Operative time.
- Postoperative pain.
- The incidence of other complications.
- Postoperative cosmetic outcome.
- The duration to walk, sit on toilet free from pain.
- The duration till complete daily activities.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pilonidal Sinus InfectedStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Dify Kamal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152952
- Sponsor's protocol ID
- pilonidal sinus
- Status last verified
- Dec 2023
- First submitted
- 12 Nov 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Esposito C, Cerulo M, Esposito G, Turco A, Borgogni R, Carulli R, Di Mento C, Del Conte F, Coppola V, Escolino M. Endoscopic Treatment of Pilonidal Sinus Disease in Children: A Systematic Review. J Laparoendosc Adv Surg Tech A. 2023 May;33(5):512-517. doi: 10.1089/lap.2022.0564. Epub 2023 Apr 6.
PubMed 37023403Konoplitskyi V, Shavliuk R, Dmytriiev D, Dmytriiev K, Kyrychenko O, Zaletskyi B, Olkhomiak O. Pilonidal disease: changes in understanding of etiology, pathogenesis and approach to treatment. Wiad Lek. 2019 Aug 31;72(8):1559-1565.
PubMed 32012508Harries RL, Alqallaf A, Torkington J, Harding KG. Management of sacrococcygeal pilonidal sinus disease. Int Wound J. 2019 Apr;16(2):370-378. doi: 10.1111/iwj.13042. Epub 2018 Nov 15.
PubMed 30440104Grabowski J, Oyetunji TA, Goldin AB, Baird R, Gosain A, Lal DR, Kawaguchi A, Downard C, Sola JE, Arthur LG, Shelton J, Diefenbach KA, Kelley-Quon LI, Williams RF, Ricca RL, Dasgupta R, St Peter SD, Somme S, Guner YS, Jancelewicz T. The management of pilonidal disease: A systematic review. J Pediatr Surg. 2019 Nov;54(11):2210-2221. doi: 10.1016/j.jpedsurg.2019.02.055. Epub 2019 Mar 19.
PubMed 30948198de Parades V, Bouchard D, Janier M, Berger A. Pilonidal sinus disease. J Visc Surg. 2013 Sep;150(4):237-47. doi: 10.1016/j.jviscsurg.2013.05.006. Epub 2013 Aug 1.
PubMed 23911903
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Rhomboid Flap Outcome in the Surgical Treatment of Recurrent Sacrococcygeal Pilonidal Sinus vs. Deep Suturing
- ClinicalTrials.gov ID
- NCT06152952
- Acronym / sponsor ID
- pilonidal sinus
- Conditions
- Pilonidal Sinus Infected
- Keywords
- Rhomboid flap, Deep suturing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 1 Dec 2023 (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.
This prospective clinical trial aims to compare the perioperative outcomes of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease.
Detailed description
Pilonidal disease derives its name from Latin- pilus meaning "hair," and nidus meaning "nest" . The source of pilonidal disease is thought to be a deep intergluteal sulcus. It is widely accepted that the establishment of the pilonidal sinus results from the penetration of shed hair shafts through the skin, which ultimately leads to an acute or chronic infected site .
Pilonidal disease is largely considered a surgical disease, especially in acute instances with secondary infection and abscess. Infection or abscess requires incision and drainage. Definitive treatment is delayed the majority of the time if there is an acute infection or abscess until after the infection has been addressed. Surgical options for chronic disease are numerous and can include "pit picking," curettage, aspiration, unroofing, or surgical excision. Defects can be closed primarily, with flaps or grafts, or allowed to heal by secondary intention .
The most serious problem of the various surgical approaches proposed is the recurrence rate, ranging from 0% to 40% .
The surgical treatment of patients with recurrent disease does not differ from the surgical treatment of primary pilonidal disease. In case of a recurrence with an abscess, incision and drainage prevail, while in case of chronic recurrent disease, a flap based procedure may be indicated following sinus excision with scarring, like the rhomboid flap .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 : The rhomboid flap Approach | – | Procedure: The rhomboid flap approachThe flap will be dissected deep to the gluteal fascia (subfascial level) so as to raise thick a fasciocutaneous flap. This will assure good vascularity of the flap without dead space. The rhomboid flap (CDEF) will be mobilized from the gluteal fascia and sutured without tension in three layers (gluteal fascia with 2/0 Vicryl, subcutaneous fat with 3/0 Vicryl, and the skin with 4/0 Prolene). As all sides will be equal in length, the flap fits in place without tension. A suction drain will be left behind and the wound will be dressed as usual. Pressure wound dressing will be applied and removed on the third postoperative day. |
| Group 2 : The deep suturing approach | – | Procedure: The rhomboid flap approachA vertical elliptical incision encompassing all pilonidal pits will be made and excision of the sinus will be carried out down to the level of the sacrococcygeal fascia. Tension will be released by a limited sharp dissection above the fascia. After haemostasis is ensured using electrocautery, a suction drain will be inserted through a separate incision, then the deep fascia will be approximated and the wound will be closed in layers using polyglactin 0 sutures. Finally, the skin will be closed with 2/0 polypropylene interrupted mattress sutures. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Diversity in population, some come from a rural environment and others from the city
Key inclusion criteria (3 listed)
- Adult patients aged between 18 and 60 years;
- Patients with one or two small inactive sinuses will be included for easier excisional procedures;
- Previous intervention for pilonidal disease whether surgical or non-surgical;
Key exclusion criteria (1 listed)
- 1 - Patients with an acute abscess. 2- Patients with mall inactive pilonidal sinus disease. 3- Age beyond the previous limits. 4- Patients with primary pilonidal disease. 5- Refusal to participate in the study. 6- Unfit for anaesthesia and surgery. 7- Patients with malignant neoplasms or inflammatory bowel disease.
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 |
|---|---|---|
| The rhomboid flap approachAlso: The deep suturing approachThe rhomboid flap Approach : The flap will be dissected deep to the gluteal fascia (subfascial level) so as to raise thick a fasciocutaneous flap. This will assure good vascularity of the flap without dead space. The rhomboid flap (CDEF) will be mobilized from the gluteal fascia and sutured without tension in three layers The deep suturing approach : A vertical elliptical incision encompassing all pilonidal pits will be made and excision of the sinus will be carried out down to the level of the sacrococcygeal fascia. T then the deep fascia will be approximated and the wound will be closed | Procedure or surgery | Group 1 : The rhomboid flap Approach, Group 2 : The deep suturing approach |
Primary outcome
Primary Outcome of comparing the perioperative of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease.
Time frame: baseline
Primary Outcome : Postoperative recurrence rate. Recurrence will be defined as the additional outbreak of signs and symptoms of pilonidal disease after a disease-free interval following complete wound healing
1 secondary outcome
Secondary Outcome (subsidiary)of comparing the perioperative of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease.
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 37023403Esposito C, Cerulo M, Esposito G, Turco A, Borgogni R, Carulli R, Di Mento C, Del Conte F, Coppola V, Escolino M. Endoscopic Treatment of Pilonidal Sinus Disease in Children: A Systematic Review. J Laparoendosc Adv Surg Tech A. 2023 May;33(5):512-517. doi: 10.1089/lap.2022.0564. Epub 2023 Apr 6.
- Background: PubMed 32012508Konoplitskyi V, Shavliuk R, Dmytriiev D, Dmytriiev K, Kyrychenko O, Zaletskyi B, Olkhomiak O. Pilonidal disease: changes in understanding of etiology, pathogenesis and approach to treatment. Wiad Lek. 2019 Aug 31;72(8):1559-1565.
- Background: PubMed 30440104Harries RL, Alqallaf A, Torkington J, Harding KG. Management of sacrococcygeal pilonidal sinus disease. Int Wound J. 2019 Apr;16(2):370-378. doi: 10.1111/iwj.13042. Epub 2018 Nov 15.
- Background: PubMed 30948198Grabowski J, Oyetunji TA, Goldin AB, Baird R, Gosain A, Lal DR, Kawaguchi A, Downard C, Sola JE, Arthur LG, Shelton J, Diefenbach KA, Kelley-Quon LI, Williams RF, Ricca RL, Dasgupta R, St Peter SD, Somme S, Guner YS, Jancelewicz T. The management of pilonidal disease: A systematic review. J Pediatr Surg. 2019 Nov;54(11):2210-2221. doi: 10.1016/j.jpedsurg.2019.02.055. Epub 2019 Mar 19.
- Background: PubMed 23911903de Parades V, Bouchard D, Janier M, Berger A. Pilonidal sinus disease. J Visc Surg. 2013 Sep;150(4):237-47. doi: 10.1016/j.jviscsurg.2013.05.006. Epub 2013 Aug 1.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pilonidal Sinus Infected, run by Assiut University.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Dify, G.P. (00201022552241, Ahmeddify94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome of comparing the perioperative of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease. (time frame: baseline). 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 NCT06152952, which also lists 5 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 5 Dec 2023.