Randomized Controlled Trial of Shang Ring Male Children Circumcision: Comparison Between Flip and No Flip Technique
Human Immunodeficiency Virus
About this trial
This is an interventional device feasibility trial for Human Immunodeficiency Virus focused on measuring Circumcision, Male, Shang Ring, Children, Foreskin
Eligibility Criteria
Inclusion Criteria:
- Aged between 7 years and 12 years(inclusive);
- Must be accompanied by the parent or legally acceptable representative (LAR), who freely agrees with participation of the child into the study;
- Must tolerate local anesthesia;
- Must be in good general health;
- Parent or LAR and if possible the client must be able to understand study procedures and requirements of study participation;
- Parent or LAR must agree to return the client to the study site for the full schedule of follow-up visits after his circumcision;
- Parent or LAR must agree the study staff to take photos during operation or follow-up if necessary, and
- Parent or LAR must agree to provide the study staff with an address, phone number, or other locator information
Exclusion Criteria:
- Has a known allergy or sensitivity to lidocaine or other local anesthesia;
- Takes a medication that would be a contraindication for elective surgery (e.g anticoagulant , steroid);
- Has known bleeding/clotting disorder (e.g. hemophilia);
- Has an active genital infection, anatomic abnormality or other condition(e.g. concealed penis, hypospadias, epispadia, micropenis);
- Is currently participating in another biomedical research study; or
- Participants under other condition (e.g. severe obesity, diabetes or sickle cell anemia) should be excluded from this study in the opinion of the surgeon.
Sites / Locations
- The Affiliated Hospital of Medical College, Ningbo University
- Ningbo NO.1 hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
No flip technique
Flip technique
One group of boys will undergo a circumcision with no flip technique of Shang Ring Circumcision and receive regular follow-up to evaluate pain, operation associated adverse events, wound healing time. The Shang Ring will detach spontaneously without intervention, and the participants are asked to have a visit soon after ring detached. The last scheduled follow-up visit is at 90 days.
One group of boys will undergo a circumcision with flip technique of Shang Ring Circumcision and receive regular follow-up to evaluate pain, operation associated adverse events, wound healing time. The Shang Ring will be removed at 7 days, and the last scheduled follow-up visit is at 90 days.