Circumcision, MaleNCT07750093
A Study Comparing The Effect Of Local Application Of Polyfax Versus Coconut Oil On Outcome Of Plastibell Circumcision In A Tertiary Care Hospital
A study testing agent used for local application in people with Circumcision, Male, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to compare the frequency of post-circumcision complications (bleeding, infection, and delayed ring separation) time for ring separation and level of parental satisfaction following local application of Polyfax versus coconut oil after Plastibell circumcision in infants in. Read more about this study
- Who is it for?
- Ages 1 week to 6 months, men only
- Conditions the study is for
- Circumcision, Male
- What is being tested?
- agent used for local application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 week to 6 months
- Men only
- No healthy volunteers
- Child
Who may be able to join
- -All male patients undergoing Plastibell circumcision <6m of age, whose parents/ guardians have given consent
Who cannot join
- Patient with a known coagulation disorder
- Immunosuppressed patients
- Patients with a dermatologic condition
- Non-compliant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of Effect Of Local Application Of Polyfax Versus Coconut Oil On Outcome Of Plastibell Circumcision In A Tertiary Care Hospital
The goal of this clinical trial is to compare the frequency of post-circumcision complications (bleeding, infection, and delayed ring separation) time for ring separation and level of parental satisfaction following local application of Polyfax versus coconut oil after Plastibell circumcision in infants in. Patient undergoing Plastibell circumcision will be divided into 2 groups, we will prescribe Polyfax to one group as a part of post circumcision care and coconut oil to the other group. Division into groups will be random using the lottery method, participant will visit the clinic at 1 week, 3 months and 6 months. A questionnaire will be filled by the doctor.
Read the detailed description
Objective of study:
- To compare the frequency of post-circumcision complications-such as bleeding, infection, and delayed ring separation-following local application of Polyfax versus coconut oil after Plastibell circumcision in infants (<6 months of age).
- To compare the time for ring separation between the two treatment groups.
- To compare the level of parental satisfaction following the use of Polyfax versus coconut oil
Methodology The patient who fulfill the inclusion criteria will be included in the study. Patient undergoing Plastibell circumcision will be divided into 2 groups, we will prescribe Polyfax to one group as a part of post circumcision care and coconut oil to the other group. Division into groups will be random using the lottery method. Half the envelopes will contain a card with polyfax on it and the other half will have coconut oil. A questionnaire will be filled by the doctor for all post circumcision patients undergoing plastibell circumcision whose guardians have given consent to be included in the study. Demographic details such as age and weight will be recorded from the patient file. All patients will undergo a standard Plastibell circumcision in the daycare theatre. An assistant will gently restrain the infant, after adequate exposure local anesthesia is given in form of a penile block. Diluted lidocain prepared according to weight of child is injected at base of phallus at 1 and 11 o clock. A dorsal slit is made in the foreskin and adhesions between foreskin and glans are removed. A Plastibell is then introduced between glans and prepuce and hemostatic ligature is tied around base of prepuce overlying a groove in Plastibell. Foreskin distal to ligature is excised. The surgical site is cleaned either polyfax or coconut oil is applied. The child will be redressed and returned to parents and detailed instructions will be provided to parents regarding the postoperative care and follow up verbally and in writing. Data regarding outcome will be gathered by interviewing the parents as well as through clinical examination in the OPD. Data will be entered and analyzed via SPSS. The effect modifiers and biasness will be controlled by strictly following the inclusion and exclusion criteria and use of lottery method.
- Conditions
- Circumcision, Male
- Being tested
- agent used for local application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
agent used for local applicationOther
agent used for local application post procedure
| Study group | Role | What they receive |
|---|---|---|
| Coconut oil group | Experimental | coconut oil used for local application Receives: Other: agent used for local application |
| Polyfax | Experimental | Polyfax for local application Receives: Other: agent used for local application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Post circumcision bleeding, infection, delayed ring seperation
Measured: 3 months
Secondary outcomes (1)
Parental satisfaction
Parental satisfaction level (satisfied, very satisfied, neutral, unsatisfied, very unsatisfied)
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Jul 2025
- Primary completion31 Jul 2026
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circumcision, MaleStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat National Hospital & Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saiyeda Mahin Fatima, Liaquat National Hospital & Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750093
- Sponsor's protocol ID
- POLYFAX-VS-COCONUTOIL
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Effect Of Local Application Of Polyfax Versus Coconut Oil On Outcome Of Plastibell Circumcision In A Tertiary Care Hospital
- ClinicalTrials.gov ID
- NCT07750093
- Acronym / sponsor ID
- POLYFAX-VS-COCONUTOIL
- Conditions
- Circumcision, Male
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 6 Aug 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 clinical trial is to compare the frequency of post-circumcision complications (bleeding, infection, and delayed ring separation) time for ring separation and level of parental satisfaction following local application of Polyfax versus coconut oil after Plastibell circumcision in infants in. Patient undergoing Plastibell circumcision will be divided into 2 groups, we will prescribe Polyfax to one group as a part of post circumcision care and coconut oil to the other group. Division into groups will be random using the lottery method, participant will visit the clinic at 1 week, 3 months and 6 months. A questionnaire will be filled by the doctor.
Detailed description
Objective of study:
- To compare the frequency of post-circumcision complications-such as bleeding, infection, and delayed ring separation-following local application of Polyfax versus coconut oil after Plastibell circumcision in infants (<6 months of age).
- To compare the time for ring separation between the two treatment groups.
- To compare the level of parental satisfaction following the use of Polyfax versus coconut oil
Methodology The patient who fulfill the inclusion criteria will be included in the study. Patient undergoing Plastibell circumcision will be divided into 2 groups, we will prescribe Polyfax to one group as a part of post circumcision care and coconut oil to the other group. Division into groups will be random using the lottery method. Half the envelopes will contain a card with polyfax on it and the other half will have coconut oil. A questionnaire will be filled by the doctor for all post circumcision patients undergoing plastibell circumcision whose guardians have given consent to be included in the study. Demographic details such as age and weight will be recorded from the patient file. All patients will undergo a standard Plastibell circumcision in the daycare theatre. An assistant will gently restrain the infant, after adequate exposure local anesthesia is given in form of a penile block. Diluted lidocain prepared according to weight of child is injected at base of phallus at 1 and 11 o clock. A dorsal slit is made in the foreskin and adhesions between foreskin and glans are removed. A Plastibell is then introduced between glans and prepuce and hemostatic ligature is tied around base of prepuce overlying a groove in Plastibell. Foreskin distal to ligature is excised. The surgical site is cleaned either polyfax or coconut oil is applied. The child will be redressed and returned to parents and detailed instructions will be provided to parents regarding the postoperative care and follow up verbally and in writing. Data regarding outcome will be gathered by interviewing the parents as well as through clinical examination in the OPD. Data will be entered and analyzed via SPSS. The effect modifiers and biasness will be controlled by strictly following the inclusion and exclusion criteria and use of lottery method.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coconut oil group | Experimental | Other: agent used for local applicationcoconut oil used for local application |
| Polyfax | Experimental | Other: agent used for local applicationPolyfax for local application |
Who may qualify
- Ages
- 1 week to 6 months
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -All male patients undergoing Plastibell circumcision <6m of age, whose parents/ guardians have given consent
Key exclusion criteria (4 listed)
- Patient with a known coagulation disorder
- Immunosuppressed patients
- Patients with a dermatologic condition
- Non-compliant patients
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 |
|---|---|---|
| agent used for local applicationagent used for local application post procedure | Other | Coconut oil group, Polyfax |
Primary outcome
Complications
Time frame: 3 months
Post circumcision bleeding, infection, delayed ring seperation
1 secondary outcome
Parental satisfaction
Time frame: 3 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- 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 agent used for local application in people with Circumcision, Male, run by Liaquat National Hospital & Medical College 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 1 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 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?
This study is still under way. Results are not available in the source record yet.
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?
Complications (time frame: 3 months). 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 11 Aug 2026.