Wound InfectionNCT07798752
Comparison of Primary Closure Vs Open Wound in Pilonidal Sinus Excision.
A study testing Primary Closure Technique and Open Technique in people with Wound Infection and Primary Closure, run by Hayatabad Medical Complex at 1 site in Pakistan.
Trial summary
The goal of this randomized clinical trial is to compare wound infection rates after two surgical techniques for treating pilonidal sinus in adults. The main question this study aims to answer is: Is wound infection less common after primary closure than after the open technique? Researchers will compare patients who… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Infection, Primary Closure, Sacrococcygeal Pilonidal Sinus
- What is being tested?
- Primary Closure Technique and Open Technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2025to 10 Aug 2026
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male \&Female
- Age between (18-75) Years
- Patients with pilonidal sinus as defined in the operational definition.
Who cannot join
- Patients with debilitating disease
- Patients with immunocompromised state like malignancy, and tuberculosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Wound Infection in Patients Undergoing Primary Closure and Open Technique in The Treatment of Pilonidal Sinus.
The goal of this randomized clinical trial is to compare wound infection rates after two surgical techniques for treating pilonidal sinus in adults.
The main question this study aims to answer is:
Read more
Is wound infection less common after primary closure than after the open technique? Researchers will compare patients who receive primary closure with patients who receive the open technique after removal of the pilonidal sinus. The study will include 68 men and women between 18 and 75 years of age. Participants will be randomly assigned to one of the two treatment groups.
Participants will:
Undergo surgery using either primary closure or the open technique. Attend follow-up visits after surgery. Have the surgical wound examined 7 days after the procedure. Provide information about their health, medical history, and recovery. The study will record whether participants develop wound infection, including swelling, redness, or pus or clear fluid coming from the wound. The study will be conducted in the General Surgery Department at Medical Institute Haytabad Medical Complex, Peshawar.
Read the detailed description
Detailed Description
Pilonidal sinus is a chronic condition involving the skin and subcutaneous tissue in the sacrococcygeal or natal cleft region. It commonly presents with one or more midline openings, local pain, redness, swelling, or discharge. Surgical treatment is frequently required for symptomatic disease. However, the most appropriate method of wound management after excision remains uncertain. Primary closure may allow faster wound healing and reduce the period of open wound care, whereas the open technique may reduce tension on the wound but requires healing by secondary intention and regular dressing care.
This randomized controlled trial will compare two surgical approaches for the treatment of pilonidal sinus: primary closure and open healing. The study will be conducted in the General Surgery Department of Hayatabad Medical COmplex, Peshawar, after approval from the relevant institutional ethical review board and the research department of the College of Physicians and Surgeons Pakistan, Karachi.
Eligible participants who provide written informed consent will be assigned to one of two treatment groups using blocked randomization:
Group A: Excision of the pilonidal sinus followed by primary closure. Group B: Excision of the pilonidal sinus followed by open wound management and healing by secondary intention.
Before surgery, the research team will record relevant demographic and clinical information. Participants will undergo a clinical examination and routine preoperative assessment according to institutional practice. The surgical procedures will be performed under appropriate anesthesia by, or under the supervision of, a qualified general surgeon.
For participants in Group A, the sinus and surrounding diseased tissue will be excised down to the level of the sacral fascia. Any secondary tracts identified during surgery will also be removed. After achieving hemostasis, the wound will be closed in layers using polypropylene sutures. The closure will include approximation of the deeper tissues and skin. A suction drain may be placed when clinically indicated. The wound will then be covered with an appropriate sterile dressing.
For participants in Group B, the sinus and surrounding diseased tissue will be excised down to the sacral fascia. After hemostasis, the resulting cavity will be packed with povidone-iodine-soaked gauze. The initial packing will be removed approximately 48 hours after surgery. The wound will then remain open and will be managed with regular dressings until healing is complete. Participants in this group will attend outpatient follow-up visits, generally on a weekly basis or as clinically required.
Participants in both groups will receive postoperative care according to the hospital's standard practice. This may include analgesics, wound-care instructions, advice regarding hygiene, and instructions to return to the hospital if they develop worsening pain, fever, swelling, redness, or discharge. Follow-up assessment will be performed by the research team under the supervision of a consultant surgeon.
Information collected during the study will be recorded on a structured data-collection proforma. Each participant will be assigned a study identification number. Personal information will be kept confidential and will be accessed only by authorized members of the research team. The study findings will be analyzed to compare the postoperative wound outcomes of the two surgical techniques.
The study is intended to provide local clinical evidence regarding the choice between primary closure and open wound management after pilonidal sinus excision. The findings may help surgeons and healthcare professionals make evidence-based decisions about postoperative management and patient counseling.
- Conditions
- Wound Infection, Primary Closure, Sacrococcygeal Pilonidal Sinus, Pilonidal Sinus Treatment
- Being tested
- Primary Closure Technique, Open Technique
- Keywords
- Sacrococcygeal pilonidal sinus, pilonidal sinus, Pilonidal sinus Treatment, Primary Closure flaps, Wound Infection, Pilonidal Sinus Infections
- Medical subject headings
- Wound Infection, Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Closure TechniqueProcedure or surgery
Also called Primary Closure
Excision of sinus tract with closure using Prolene sutures and placement of suction drain.
Open TechniqueProcedure or surgery
Also called Surgical excision with open wound management
Excision of sinus tract with open wound packing and secondary healing.
| Study group | Role | What they receive |
|---|---|---|
| Primary Closure Technique | Experimental | Patients undergo excision of the pilonidal sinus and surrounding tissue down to the sacral fascia, followed by closure with polypropylene sutures. A suction drain (Radivac system) is placed, and vertical mattress sutures are used to approximate skin and subcutaneous tissue. Receives: Procedure: Primary Closure Technique |
| Open Technique | Active comparator | Patients undergo excision of the pilonidal sinus with surrounding tissue down to sacral fascia. The wound is left open and packed with pyodine-soaked gauze. Patients return for weekly outpatient follow-up until complete healing. Receives: Procedure: Open Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Infection
Frequency of wound infection within 30 days post-surgery
Measured: From surgery to 30 days post-operation
Secondary outcomes (2)
Wound healing time
Healing assessed weekly until closure.
Measured: From date of Surgery until 90 days.
Surgery time
Duration of intervention recorded in minutes.
Measured: During surgical procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Jan 2025
- Primary completion5 Aug 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Wound InfectionStudies 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
- Model description
- Participants are randomly assigned in a 1:1 ratio to one of two parallel groups: Group A (Primary Closure technique) or Group B (Open technique). Randomization was computer-generated and allocation concealment was ensured by an independent researcher. Patients remained blinded to the treatment received, while care providers and outcome assessors were aware of group allocation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hayatabad Medical Complex
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yousaf Jan, Hayatabad Medical Complex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798752
- Sponsor's protocol ID
- RMI_QAD_RCT_PILONOIDAL_sINUS
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data (demographics, wound infection outcomes, healing times) will be shared upon reasonable request to the principal investigator after study completion. Access will be granted to qualified researchers for academic purposes only.
Publications
Jabbar MS, Bhutta MM, Puri N. Comparison between primary closure with Limberg Flap versus open procedure in treatment of pilonidal sinus, in terms of frequency of post-operative wound infection. Pak J Med Sci. 2018 Jan-Feb;34(1):49-53. doi: 10.12669/pjms.341.13929.
PubMed 29643877Kober MM, Alapati U, Khachemoune A. Treatment options for pilonidal sinus. Cutis. 2018 Oct;102(4):E23-E29.
PubMed 30489572Iesalnieks I, Ommer A. The Management of Pilonidal Sinus. Dtsch Arztebl Int. 2019 Jan 7;116(1-2):12-21. doi: 10.3238/arztebl.2019.0012.
PubMed 30782310
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Wound Infection in Patients Undergoing Primary Closure and Open Technique in The Treatment of Pilonidal Sinus.
- ClinicalTrials.gov ID
- NCT07798752
- Acronym / sponsor ID
- RMI_QAD_RCT_PILONOIDAL_sINUS
- Conditions
- Wound Infection, Primary Closure, Sacrococcygeal Pilonidal Sinus, Pilonidal Sinus Treatment
- Keywords
- Sacrococcygeal pilonidal sinus, pilonidal sinus, Pilonidal sinus Treatment, Primary Closure flaps, Wound Infection, Pilonidal Sinus Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Hayatabad Medical ComplexOther government
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 5 Aug 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 1 Sep 2026 (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 goal of this randomized clinical trial is to compare wound infection rates after two surgical techniques for treating pilonidal sinus in adults.
The main question this study aims to answer is:
Is wound infection less common after primary closure than after the open technique? Researchers will compare patients who receive primary closure with patients who receive the open technique after removal of the pilonidal sinus. The study will include 68 men and women between 18 and 75 years of age. Participants will be randomly assigned to one of the two treatment groups.
Participants will:
Undergo surgery using either primary closure or the open technique. Attend follow-up visits after surgery. Have the surgical wound examined 7 days after the procedure. Provide information about their health, medical history, and recovery. The study will record whether participants develop wound infection, including swelling, redness, or pus or clear fluid coming from the wound. The study will be conducted in the General Surgery Department at Medical Institute Haytabad Medical Complex, Peshawar.
Detailed description
Detailed Description
Pilonidal sinus is a chronic condition involving the skin and subcutaneous tissue in the sacrococcygeal or natal cleft region. It commonly presents with one or more midline openings, local pain, redness, swelling, or discharge. Surgical treatment is frequently required for symptomatic disease. However, the most appropriate method of wound management after excision remains uncertain. Primary closure may allow faster wound healing and reduce the period of open wound care, whereas the open technique may reduce tension on the wound but requires healing by secondary intention and regular dressing care.
This randomized controlled trial will compare two surgical approaches for the treatment of pilonidal sinus: primary closure and open healing. The study will be conducted in the General Surgery Department of Hayatabad Medical COmplex, Peshawar, after approval from the relevant institutional ethical review board and the research department of the College of Physicians and Surgeons Pakistan, Karachi.
Eligible participants who provide written informed consent will be assigned to one of two treatment groups using blocked randomization:
Group A: Excision of the pilonidal sinus followed by primary closure. Group B: Excision of the pilonidal sinus followed by open wound management and healing by secondary intention.
Before surgery, the research team will record relevant demographic and clinical information. Participants will undergo a clinical examination and routine preoperative assessment according to institutional practice. The surgical procedures will be performed under appropriate anesthesia by, or under the supervision of, a qualified general surgeon.
For participants in Group A, the sinus and surrounding diseased tissue will be excised down to the level of the sacral fascia. Any secondary tracts identified during surgery will also be removed. After achieving hemostasis, the wound will be closed in layers using polypropylene sutures. The closure will include approximation of the deeper tissues and skin. A suction drain may be placed when clinically indicated. The wound will then be covered with an appropriate sterile dressing.
For participants in Group B, the sinus and surrounding diseased tissue will be excised down to the sacral fascia. After hemostasis, the resulting cavity will be packed with povidone-iodine-soaked gauze. The initial packing will be removed approximately 48 hours after surgery. The wound will then remain open and will be managed with regular dressings until healing is complete. Participants in this group will attend outpatient follow-up visits, generally on a weekly basis or as clinically required.
Participants in both groups will receive postoperative care according to the hospital's standard practice. This may include analgesics, wound-care instructions, advice regarding hygiene, and instructions to return to the hospital if they develop worsening pain, fever, swelling, redness, or discharge. Follow-up assessment will be performed by the research team under the supervision of a consultant surgeon.
Information collected during the study will be recorded on a structured data-collection proforma. Each participant will be assigned a study identification number. Personal information will be kept confidential and will be accessed only by authorized members of the research team. The study findings will be analyzed to compare the postoperative wound outcomes of the two surgical techniques.
The study is intended to provide local clinical evidence regarding the choice between primary closure and open wound management after pilonidal sinus excision. The findings may help surgeons and healthcare professionals make evidence-based decisions about postoperative management and patient counseling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to one of two parallel groups: Group A (Primary Closure technique) or Group B (Open technique). Randomization was computer-generated and allocation concealment was ensured by an independent researcher. Patients remained blinded to the treatment received, while care providers and outcome assessors were aware of group allocation.
| Arm | Type | Receives |
|---|---|---|
| Primary Closure Technique | Experimental | Procedure: Primary Closure TechniquePatients undergo excision of the pilonidal sinus and surrounding tissue down to the sacral fascia, followed by closure with polypropylene sutures. A suction drain (Radivac system) is placed, and vertical mattress sutures are used to approximate skin and subcutaneous tissue. |
| Open Technique | Active comparator | Procedure: Open TechniquePatients undergo excision of the pilonidal sinus with surrounding tissue down to sacral fascia. The wound is left open and packed with pyodine-soaked gauze. Patients return for weekly outpatient follow-up until complete healing. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male \&Female
- Age between (18-75) Years
- Patients with pilonidal sinus as defined in the operational definition.
Key exclusion criteria (2 listed)
- Patients with debilitating disease
- Patients with immunocompromised state like malignancy, and tuberculosis.
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 Closure TechniqueAlso: Primary ClosureExcision of sinus tract with closure using Prolene sutures and placement of suction drain. | Procedure or surgery | Primary Closure Technique |
| Open TechniqueAlso: Surgical excision with open wound managementExcision of sinus tract with open wound packing and secondary healing. | Procedure or surgery | Open Technique |
Primary outcome
Wound Infection
Time frame: From surgery to 30 days post-operation
Frequency of wound infection within 30 days post-surgery
2 secondary outcomes
Wound healing time
Time frame: From date of Surgery until 90 days.
Surgery time
Time frame: During surgical procedure.
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 1 Sep 2026.
- Results publication: PubMed 29643877Jabbar MS, Bhutta MM, Puri N. Comparison between primary closure with Limberg Flap versus open procedure in treatment of pilonidal sinus, in terms of frequency of post-operative wound infection. Pak J Med Sci. 2018 Jan-Feb;34(1):49-53. doi: 10.12669/pjms.341.13929.
- Results publication: PubMed 30489572Kober MM, Alapati U, Khachemoune A. Treatment options for pilonidal sinus. Cutis. 2018 Oct;102(4):E23-E29.
- Results publication: PubMed 30782310Iesalnieks I, Ommer A. The Management of Pilonidal Sinus. Dtsch Arztebl Int. 2019 Jan 7;116(1-2):12-21. doi: 10.3238/arztebl.2019.0012.
- Individual participant dataSharing planned: Yes. De-identified participant data (demographics, wound infection outcomes, healing times) will be shared upon reasonable request to the principal investigator after study completion. Access will be granted to qualified researchers for academic purposes only.
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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 Closure Technique and Open Technique in people with Wound Infection and Primary Closure, run by Hayatabad Medical Complex 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 2 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 1 Sep 2026. 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?
Wound Infection (time frame: From surgery to 30 days post-operation). 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 NCT07798752, which also lists 3 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 1 Sep 2026.