Circumcision, Male
Conditions
Brief 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. 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.
Interventions
OTHERagent used for local application
agent used for local application post procedure
Sponsors
Liaquat National Hospital & Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
1 Weeks to 6 Months
Healthy volunteers
No
Inclusion criteria
-All male patients undergoing Plastibell circumcision \<6m of age, whose parents/ guardians have given consent
Exclusion criteria
* Patient with a known coagulation disorder * Immunosuppressed patients * Patients with a dermatologic condition * Non-compliant patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 3 months | Post circumcision bleeding, infection, delayed ring seperation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parental satisfaction | 3 month | Parental satisfaction level (satisfied, very satisfied, neutral, unsatisfied, very unsatisfied) |
Countries
Pakistan
Outcome results
None listed