Neonatal male circumcision feasible in resource-limited settings; Mogen clamp may have advantages

Neonatal male circumcision can be safely performed in resource-limited settings, according to the results of a study conducted in Botswana and published in the online edition of the Journal of Acquired Immune Deficiency Syndromes. Infants were circumcised within 28 days of birth. There were few complications and high levels of parental satisfaction. However, the investigators caution that availability of medical supplies and the high levels of infant mortality seen in sub-Saharan Africa are likely to be barriers routine neonatal male circumcision.

Randomised controlled trials have shown that circumcised men have a reduced risk of infection with HIV. Male circumcision is therefore being rolled out in a number of sub-Saharan African countries with generalised HIV epidemics.

Neonatal male circumcision has been proposed as one component of medical circumcision programmes for HIV prevention, which chiefly target adolescent males and sexually active adult males. Implementing a policy of neonatal male circumcision would have a more delayed impact on HIV prevalence, but would be a cost-effective way of achieving a high level of coverage of male circumcision.

Other than in the context of religious custom, neonatal male circumcision in resource-limited countries is rare. Accordingly, little is known about the safety and acceptability of circumcision devices in such settings.

Investigators therefore designed a randomised study to see if two commonly used circumcision devices – the Mogen clamp and Plastibell – were suitable for use in resource-limited countries.

The Mogen clamp is a reusable stainless steel device that requires a new, sterile blade for each procedure. The Plastibell is a disposable plastic device that comes in six sizes, and requires stainless steel scissors, which can be sterilised and reused.

The study was conducted in Botswana between 2009 and 2010. A total of 808 mothers with healthy infant boys were offered the opportunity to participate in the study; 55% consented and 300 newborn boys were circumcised. In 51% of cases, circumcision was performed using the Mogen clamp; the other 49% of boys were circumcised used Plastibell. Each circumcision was performed by a physician in clean rather than sterile conditions. The physician had no experience of neonatal circumcision before this study and received appropriate training according to WHO guidance.

Procedures were performed in a mean of 5.5 minutes using the Mogen clamp and 7.2 minutes using the Plastibell, a significant difference (p < 0.0001).

A total of 34 adverse events were observed in 30 infants. Two of these – both involving Plastibell migration – were classified as serious. In each case, the ring had to be removed by study staff, one at day 14, the other at day 17. However, in neither case did migration of Plastibell lead to any complications.

 “Because of the potential for serious morbidity and even mortality if a neonate with a retained Plastibell is not brought quickly to medical attention, we defined a retained Plastibell as a major adverse event,” explain the authors. “Potential complications of a retained Plastibell include, but are not limited to, urinary retention, bladder rupture and necrosis of the glans.”

Minor adverse events were more common with the Mogen clamp than the Plastibell. These included the removal of too little skin, or the formation of skin bridges and adhesion (12 vs 1 and 11 vs 3 respectively, p < 0.05).

However, removal of too little skin became less common as the physician acquired more experience. The authors recommend the use of a surgical pen “to avoid the problem of removing too little skin”.

Five boys (3%) circumcised using the Mogen clamp experienced minor bleeding. However, in each case minor pressure was sufficient to stem the flow of blood.

There were no cases of systemic or localised infection.

Parental satisfaction with the procedure was high. Approximately 94% of mothers reported being highly or completely satisfied. However, levels of satisfaction were significantly lower among mothers whose infants experienced a complication (p = 0.006). Fathers were universally satisfied.

Medical staff had the impression that the Mogen clamp was better tolerated by the baby and caused less distress. However, they were evenly split between the Mogen clamp and Plastibell when asked which device should be preferred should the circumcision of newborn boys be scaled up.

The investigators were encouraged by their findings. Nevertheless, they believe that problems with supplies, especially to remote healthcare facilities, is likely to be an obstacle to the rollout of infant circumcision. They caution that no infant with any sign of neonatal illness should be circumcised until they have fully recovered.

“Neonatal male circumcision conducted under clean, rather than sterile, conditions can be performed safely in Botswana,” the authors conclude. “In areas with limited access to emergency medical care, we consider the Mogen clamp a safer choice.”