A device that allows for circumcision without the need for stitches often detaches spontaneously if worn for over seven days, according to a study published in the online edition of the Journal of Acquired Immune Deficiency Syndromes. The research also showed that the non-invasive device was safe and acceptable to both patients and healthcare staff.
The authors believe the device – called the Shang Ring – could help scale-up circumcision programmes in countries with generalised HIV epidemics.
“We demonstrated that if removal is delayed beyond 7 days, the device will eventually detach without significant problems,” write the authors. “Waiting for the Shang Ring to fall off might be a suitable service delivery strategy in settings where a removal visit may be inconvenient.”
WHO (World Health Organization) and UNAIDS recommend male circumcision as a way of reducing the risk of infection with HIV in countries with generalised epidemics.
However, a lack of trained healthcare personnel is hampering rollout efforts in some settings. Investigators from Kenya and the US have previously shown that a disposable device called the Shang Ring can be safely and effectively used for adult male circumcision.
The Shang Ring has been used to circumcise over 200,000 Chinese men. The device has two rings used to sandwich the foreskin, which is then surgically removed. It allows for circumcision without the need for stitches. It is recommended that the device should be removed seven days after circumcision.It is important to note that the Shang Ring is not the same as the Tara-Klamp circumcision device, which is associated with a high rate of complications and has been strongly criticised by activists in South Africa.
But there is some concern that men may be unable to return for device removal at this timepoint.
Therefore, an international team of investigators designed a study involving 50 Kenyan men undergoing circumcision using the Shang Ring to see if the device would detach spontaneously, and to assess its safety and acceptability.
The participants were randomised into three groups, with removal of the device scheduled to occur after seven (15 men), 14 (15 men) or 21 (20 men) days. All the men were HIV-negative and aged over 18. Most cited protection against HIV as their motivation for seeking circumcision. Participants were followed up 7, 14, 21, 28 and 42 days after circumcision and two days after removal of the Shang Ring.
All the men were circumcised without complications. The 42-day study was completed by 88% of patients.
In nine men, the foreskin was too tight for it to be sandwiched between the device. A small slit (median 1.5 cm) was therefore made in their foreskins.
A total of 17 men had the device removed on day seven. This included all 15 individuals randomised to this study arm, as well as one individual in the day-14 study arm whose device was mistakenly removed and a patient in the 21-day arm who requested removal.
Overall, 28 (58%) participants had the device removed at a study visit, including 21 on their scheduled study day and a further seven who requested removal due to pain or discomfort from a partially detached ring rubbing against the wound.
Removal of the ring was uneventful and took a median of 2.5 minutes (range, 0 to 8). Patients were asked to grade the pain during this procedure on a ten-point scale (ten being the highest). The median reported pain score was 3.8, which decreased to 1.0 within approximately ten minutes of removal. Of the men who had the device removed, 50% had at least partial detachment on the day of the procedure.
For the men still wearing the Shang Ring, the probability of at least partial detachment at days 7, 14 and 21 was 26, 94 and 100% respectively.
Complete detachment occurred in 67% of men who wore the device for more than the recommended seven days. In most cases (18 of 22), this occurred between 10 and 16 days after circumcision. The cumulative probability of spontaneous detachment as days 7, 14 and 21 were 0, 56 and 94% respectively.
In 46 men (92%), complete wound healing was achieved. Two men were lost to follow-up before complete healing. However, two men had not experienced complete healing by day 42. There was a non-significant trend (p = 0.13) for earlier healing among men who either had the device removed or who experienced spontaneous detachment approximately two weeks after circumcision.
No severe adverse events were reported, but six patients reported pain.
Generally, the men reported only minimal disruption to their everyday lives when wearing the Shang Ring. Nevertheless, a quarter of men complained of pain or discomfort during erections. All the healthcare staff reported that they found use of the device “very easy”.
“Our results contribute to the growing body of evidence that the Shang Ring could facilitate rapid roll-out male circumcision in sub-Saharan Africa,” conclude the authors. “We found no evidence of serious consequences if men do not return on time for removal.”
Barone MA et al. Randomized trial of the Shang Ring for adult male circumcision with removal at one to three weeks: delayed removal leads to detachment. J Acquir Immune Defic Syndr, online edition. DOI: 10.1097/QAI. 0b013e31824ea1f2, 2012.(Click here for the free abstract.)