Pilonidal Sinus DiseaseNCT07311707
Primary Closure vs Open Technique for Pilonidal Sinus
A study testing Primary Suturing of Surgical Wound and Open Surgical Wound Management in people with Pilonidal Sinus Disease and Sacrococcygeal Pilonidal Sinus, run by Khyber Teaching Hospital at 1 site in Pakistan.
Trial summary
The purpose of this randomized controlled trial is to compare two commonly used surgical techniques for the treatment of pilonidal sinus disease: excision with primary closure and excision with open (lay-open) technique. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Pilonidal Sinus Disease, Sacrococcygeal Pilonidal Sinus, Chronic Infected Sinus Tract
- What is being tested?
- Primary Suturing of Surgical Wound and Open Surgical Wound Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2023to 31 Dec 2023
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients aged 20 to 50 years.
- Clinically diagnosed with pilonidal sinus (persistent painful discharging wound in the buttock cleft for more than eight weeks, VAS >4).
- Patients willing to provide written informed consent.
Who cannot join
- Pilonidal sinus located away from the midline coccyx.
- Presence of abscess formation.
- Patients with underlying conditions affecting wound healing (e.g., diabetes mellitus).
- Recurrent pilonidal sinus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing Primary Closure Versus Open Surgical Technique in the Management of Pilonidal Sinus Disease
The purpose of this randomized controlled trial is to compare two commonly used surgical techniques for the treatment of pilonidal sinus disease: excision with primary closure and excision with open (lay-open) technique. Pilonidal sinus disease is a chronic inflammatory condition of the natal cleft that causes pain, discharge, and functional discomfort, particularly in young adults.
The primary aim of the study is to evaluate whether excision followed by primary closure leads to faster wound healing compared to the open surgical technique. Secondary aims include comparing postoperative wound infection and recurrence rates between the two surgical approaches.
Read more
Eligible participants aged 20 to 50 years with uncomplicated pilonidal sinus disease will be randomly allocated to one of two treatment groups. All surgical procedures will be performed by an experienced surgical team at Khyber Teaching Hospital, Peshawar. Postoperative care and follow-up schedules will be standardized for all participants. Outcomes will be assessed during follow-up visits at 1 week, 3 weeks, and 12 weeks after surgery.
This study is intended to provide evidence to guide surgical decision-making and improve postoperative outcomes for patients with pilonidal sinus disease.
Read the detailed description
Background and Rationale
Pilonidal sinus disease is a chronic inflammatory condition that primarily affects the natal cleft region and is most commonly seen in young adults. The disease is characterized by pain, discharge, recurrent infection, and limitations in daily activities, resulting in a reduced quality of life. It is more frequently observed in males and in individuals with prolonged sitting habits, obesity, or excessive body hair.
The pathogenesis of pilonidal sinus disease is widely accepted to be acquired, involving the penetration of loose hairs into the skin of the natal cleft, followed by a foreign body reaction and secondary infection. Surgical management remains the definitive treatment option, aiming to excise diseased tissue, promote wound healing, minimize complications, and reduce recurrence.
Multiple surgical techniques have been described in the literature; however, there is no universally accepted standard approach. Excision with primary closure allows immediate wound closure and potentially faster recovery, while excision with open (lay-open) technique permits healing by secondary intention and may reduce recurrence in certain cases. Variability in outcomes reported across studies highlights the need for randomized controlled trials conducted within uniform clinical settings.
This study is designed to compare these two surgical techniques under standardized operative and postoperative conditions in order to evaluate their relative effectiveness.
Study Objectives
Primary Objective To compare wound healing time between excision with primary closure and excision with open (lay-open) technique in patients with pilonidal sinus disease.
Secondary Objectives To compare the frequency of postoperative wound infection between the two surgical techniques.
To compare the rate of recurrence within the follow-up period between the two surgical techniques.
Study Design This study is a single-center, parallel-group, randomized controlled trial conducted at the Department of Surgery, Khyber Teaching Hospital, Peshawar, Pakistan. Participants will be randomly assigned in a 1:1 ratio to one of two intervention groups using a computer-generated block randomization method.
The study will be conducted in accordance with institutional ethical guidelines, and written informed consent will be obtained from all participants prior to enrollment.
Study Population Adult male and female patients aged 20 to 50 years diagnosed with uncomplicated pilonidal sinus disease will be assessed for eligibility.
Eligibility criteria, outcome measures, and follow-up schedules are defined in their respective sections of the record and are not duplicated here.
Sample Size and Sampling Technique A total sample size of 132 participants (66 per group) was calculated using the WHO sample size calculator, assuming a 95% confidence level, 80% power, and reference values from previously published studies. Eligible patients meeting inclusion criteria will be recruited using a non-probability consecutive sampling technique until the required sample size is achieved.
Randomization and Allocation Participants will be randomly allocated to one of the two study groups using computer-generated block randomization. Allocation concealment will be ensured through sealed opaque envelopes opened at the time of surgery.
Intervention Details All surgical procedures will be performed by the same surgical team with adequate experience to minimize inter-operator variability.
Group A: Excision with Primary Closure Complete excision of the pilonidal sinus tract will be performed, followed by primary wound closure using sutures after achieving adequate hemostasis.
Group B: Excision with Open (Lay-Open) Technique The pilonidal sinus tract and surrounding affected tissue will be excised, and the wound will be left open to heal by secondary intention with regular postoperative dressings.
All participants will receive standardized postoperative care, including wound dressing protocols, sitz baths, and antibiotic prophylaxis as per institutional guidelines.
Follow-up and Outcome Assessment
Participants will be evaluated postoperatively at:
1 week 3 weeks 12 weeks
Assessments will focus on wound healing status, signs of infection, and clinical evidence of recurrence. Data will be recorded using a standardized proforma by the principal investigator.
Statistical Analysis Data analysis will be performed using SPSS version 22. Quantitative variables will be summarized as mean and standard deviation, while qualitative variables will be presented as frequencies and percentages. Appropriate statistical tests will be applied to compare outcomes between groups, and a p-value of less than 0.05 will be considered statistically significant.
Key Words Pilonidal sinus disease, Primary closure, Open surgical technique, Wound healing, Wound infection, Recurrence, Randomized controlled trial
- Conditions
- Pilonidal Sinus Disease, Sacrococcygeal Pilonidal Sinus, Chronic Infected Sinus Tract, Post-surgical Wound Healing
- Being tested
- Primary Suturing of Surgical Wound, Open Surgical Wound Management
- Keywords
- Pilonidal Sinus, Primary Closure, Wound Healing, Randomized Controlled Trial, Surgical Site Infection
- Medical subject headings
- Pilonidal Sinus, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Suturing of Surgical WoundProcedure or surgery
The surgical site will be closed immediately after surgery using standard suturing techniques to approximate wound edges. This is the conventional method for wound closure in this study.
Open Surgical Wound ManagementProcedure or surgery
The surgical site will be managed using an open approach without primary closure, with standard postoperative wound care.
| Study group | Role | What they receive |
|---|---|---|
| Excision with Primary Closure | Experimental | Participants assigned to this arm will undergo complete surgical excision of the pilonidal sinus tract followed by primary closure of the wound using standard suturing techniques. All procedures will be performed by an experienced surgical team. Postoperative management will be standardized and will include routine wound care, sitz baths, and antibiotic prophylaxis according to institutional protocol. Participants will be followed postoperatively to assess wound healing progress, postoperative complications, and recurrence during scheduled follow-up visits. Receives: Procedure: Primary Suturing of Surgical Wound; Procedure: Open Surgical Wound Management |
| Excision with Open (Lay-Open) Technique | Experimental | Participants assigned to this arm will undergo complete surgical excision of the pilonidal sinus tract, with the wound left open to heal by secondary intention. Standard postoperative wound care will be provided, including regular dressings, sitz baths, and antibiotic prophylaxis according to institutional protocol. Participants will be monitored during follow-up visits to assess wound healing, postoperative complications, and recurrence. Receives: Procedure: Primary Suturing of Surgical Wound; Procedure: Open Surgical Wound Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Duration of Wound Healing After Surgery
Time (in days) from surgical intervention to complete wound epithelialization, assessed at 1, 3, and 12 weeks postoperatively, comparing primary closure versus open surgical technique.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Jul 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal Sinus DiseaseStudies 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khyber Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Asghar Ali, Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311707
- Sponsor's protocol ID
- 153/DME/KMC
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Primary Closure Versus Open Surgical Technique in the Management of Pilonidal Sinus Disease
- ClinicalTrials.gov ID
- NCT07311707
- Acronym / sponsor ID
- 153/DME/KMC
- Conditions
- Pilonidal Sinus Disease, Sacrococcygeal Pilonidal Sinus, Chronic Infected Sinus Tract, Post-surgical Wound Healing
- Keywords
- Pilonidal Sinus, Primary Closure, Wound Healing, Randomized Controlled Trial, Surgical Site Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Khyber Teaching HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 31 Dec 2025 (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 randomized controlled trial is to compare two commonly used surgical techniques for the treatment of pilonidal sinus disease: excision with primary closure and excision with open (lay-open) technique. Pilonidal sinus disease is a chronic inflammatory condition of the natal cleft that causes pain, discharge, and functional discomfort, particularly in young adults.
The primary aim of the study is to evaluate whether excision followed by primary closure leads to faster wound healing compared to the open surgical technique. Secondary aims include comparing postoperative wound infection and recurrence rates between the two surgical approaches.
Eligible participants aged 20 to 50 years with uncomplicated pilonidal sinus disease will be randomly allocated to one of two treatment groups. All surgical procedures will be performed by an experienced surgical team at Khyber Teaching Hospital, Peshawar. Postoperative care and follow-up schedules will be standardized for all participants. Outcomes will be assessed during follow-up visits at 1 week, 3 weeks, and 12 weeks after surgery.
This study is intended to provide evidence to guide surgical decision-making and improve postoperative outcomes for patients with pilonidal sinus disease.
Detailed description
Background and Rationale
Pilonidal sinus disease is a chronic inflammatory condition that primarily affects the natal cleft region and is most commonly seen in young adults. The disease is characterized by pain, discharge, recurrent infection, and limitations in daily activities, resulting in a reduced quality of life. It is more frequently observed in males and in individuals with prolonged sitting habits, obesity, or excessive body hair.
The pathogenesis of pilonidal sinus disease is widely accepted to be acquired, involving the penetration of loose hairs into the skin of the natal cleft, followed by a foreign body reaction and secondary infection. Surgical management remains the definitive treatment option, aiming to excise diseased tissue, promote wound healing, minimize complications, and reduce recurrence.
Multiple surgical techniques have been described in the literature; however, there is no universally accepted standard approach. Excision with primary closure allows immediate wound closure and potentially faster recovery, while excision with open (lay-open) technique permits healing by secondary intention and may reduce recurrence in certain cases. Variability in outcomes reported across studies highlights the need for randomized controlled trials conducted within uniform clinical settings.
This study is designed to compare these two surgical techniques under standardized operative and postoperative conditions in order to evaluate their relative effectiveness.
Study Objectives
Primary Objective To compare wound healing time between excision with primary closure and excision with open (lay-open) technique in patients with pilonidal sinus disease.
Secondary Objectives To compare the frequency of postoperative wound infection between the two surgical techniques.
To compare the rate of recurrence within the follow-up period between the two surgical techniques.
Study Design This study is a single-center, parallel-group, randomized controlled trial conducted at the Department of Surgery, Khyber Teaching Hospital, Peshawar, Pakistan. Participants will be randomly assigned in a 1:1 ratio to one of two intervention groups using a computer-generated block randomization method.
The study will be conducted in accordance with institutional ethical guidelines, and written informed consent will be obtained from all participants prior to enrollment.
Study Population Adult male and female patients aged 20 to 50 years diagnosed with uncomplicated pilonidal sinus disease will be assessed for eligibility.
Eligibility criteria, outcome measures, and follow-up schedules are defined in their respective sections of the record and are not duplicated here.
Sample Size and Sampling Technique A total sample size of 132 participants (66 per group) was calculated using the WHO sample size calculator, assuming a 95% confidence level, 80% power, and reference values from previously published studies. Eligible patients meeting inclusion criteria will be recruited using a non-probability consecutive sampling technique until the required sample size is achieved.
Randomization and Allocation Participants will be randomly allocated to one of the two study groups using computer-generated block randomization. Allocation concealment will be ensured through sealed opaque envelopes opened at the time of surgery.
Intervention Details All surgical procedures will be performed by the same surgical team with adequate experience to minimize inter-operator variability.
Group A: Excision with Primary Closure Complete excision of the pilonidal sinus tract will be performed, followed by primary wound closure using sutures after achieving adequate hemostasis.
Group B: Excision with Open (Lay-Open) Technique The pilonidal sinus tract and surrounding affected tissue will be excised, and the wound will be left open to heal by secondary intention with regular postoperative dressings.
All participants will receive standardized postoperative care, including wound dressing protocols, sitz baths, and antibiotic prophylaxis as per institutional guidelines.
Follow-up and Outcome Assessment
Participants will be evaluated postoperatively at:
1 week 3 weeks 12 weeks
Assessments will focus on wound healing status, signs of infection, and clinical evidence of recurrence. Data will be recorded using a standardized proforma by the principal investigator.
Statistical Analysis Data analysis will be performed using SPSS version 22. Quantitative variables will be summarized as mean and standard deviation, while qualitative variables will be presented as frequencies and percentages. Appropriate statistical tests will be applied to compare outcomes between groups, and a p-value of less than 0.05 will be considered statistically significant.
Key Words Pilonidal sinus disease, Primary closure, Open surgical technique, Wound healing, Wound infection, Recurrence, Randomized controlled trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Excision with Primary Closure | Experimental | Procedure: Primary Suturing of Surgical Wound, Procedure: Open Surgical Wound ManagementParticipants assigned to this arm will undergo complete surgical excision of the pilonidal sinus tract followed by primary closure of the wound using standard suturing techniques. All procedures will be performed by an experienced surgical team. Postoperative management will be standardized and will include routine wound care, sitz baths, and antibiotic prophylaxis according to institutional protocol. Participants will be followed postoperatively to assess wound healing progress, postoperative complications, and recurrence during scheduled follow-up visits. |
| Excision with Open (Lay-Open) Technique | Experimental | Procedure: Primary Suturing of Surgical Wound, Procedure: Open Surgical Wound ManagementParticipants assigned to this arm will undergo complete surgical excision of the pilonidal sinus tract, with the wound left open to heal by secondary intention. Standard postoperative wound care will be provided, including regular dressings, sitz baths, and antibiotic prophylaxis according to institutional protocol. Participants will be monitored during follow-up visits to assess wound healing, postoperative complications, and recurrence. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and female patients aged 20 to 50 years.
- Clinically diagnosed with pilonidal sinus (persistent painful discharging wound in the buttock cleft for more than eight weeks, VAS >4).
- Patients willing to provide written informed consent.
Key exclusion criteria (4 listed)
- Pilonidal sinus located away from the midline coccyx.
- Presence of abscess formation.
- Patients with underlying conditions affecting wound healing (e.g., diabetes mellitus).
- Recurrent pilonidal sinus.
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 |
|---|---|---|
| Primary Suturing of Surgical WoundThe surgical site will be closed immediately after surgery using standard suturing techniques to approximate wound edges. This is the conventional method for wound closure in this study. | Procedure or surgery | Excision with Open (Lay-Open) Technique, Excision with Primary Closure |
| Open Surgical Wound ManagementThe surgical site will be managed using an open approach without primary closure, with standard postoperative wound care. | Procedure or surgery | Excision with Open (Lay-Open) Technique, Excision with Primary Closure |
Primary outcome
Mean Duration of Wound Healing After Surgery
Time frame: 12 weeks
Time (in days) from surgical intervention to complete wound epithelialization, assessed at 1, 3, and 12 weeks postoperatively, comparing primary closure versus open surgical technique.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Suturing of Surgical Wound and Open Surgical Wound Management in people with Pilonidal Sinus Disease and Sacrococcygeal Pilonidal Sinus, run by Khyber Teaching Hospital at 1 site in Pakistan.
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 4 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: finished, as of the sponsor's last update on 31 Dec 2025. 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 Pakistan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean Duration of Wound Healing After Surgery (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2025.