One-Arm, Open-Label, Prospective, Cohort Field Study to Assess the Safety and Efficacy of the PrePex Device for Scale-Up of Nonsurgical Circumcision When Performed by Nurses in Resource-Limited Settings for HIV Prevention

Mutabazi, Vincent; Kaplan, Steven A.; Rwamasirabo, Emile; Bitega, Jean Paul; Ngeruka, Muyenzi Leon; Savio, Dominique; Karema, Corine; Binagwaho, Agnès

doi:10.1097/qai.0b013e31828e6412

Cited by 37 publications

(61 citation statements)

References 7 publications

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“…The observed rate of moderate/severe adverse events (1.4%) was similar to that reported in other PrePex studies [7], [9], [13], and comparable to rates with the Shang Ring device (1.0%) and dorsal slit surgery (0.8%) in this population [11] However, we observed 7 cases of participant self-removal of the PrePex device (2.0%), and 4 of these cases resulted in severe complications requiring immediate surgery. One Rwandan study observed two cases of self-removal in 518 PrePex procedures (0.4%) [7] but another Rwandan study of 144 PrePex recipients reported no cases [9] Unpleasant smell was reported by 71.8% of clients with 10.2% reporting that the odor was noticed by people in their vicinity.…”

Section: Discussionsupporting

confidence: 89%

“…One obstacle to MMC scale up in adolescents and adults is the time and provider skills required for conventional surgical procedures (forceps guided, dorsal slit and sleeve circumcision) all of which entail a surgical time of 15–45 minutes (depending on provider experience), aseptic conditions and skill in hemostasis and suturing for wound closure. Two devices, the Shang Ring [6] and the PrePex device [7]–[10] offer potential advantages in reduction of procedure time which could increase throughput of clients, a lower requirement for asepsis and the procedures can be performed by less skilled providers [7], [8], [10] which could facilitate task shifting and sharing. Both devices must be removed 5–9 days after placement.…”

Section: Introductionmentioning

confidence: 99%

“…The method requires secondary removal of necrotic skin at 5–9 days post-placement. Published studies of the PrePex device in Rwanda suggest that the time required for placement is ∼3 minutes [7]–[9], that lower cadre personnel such as nurses can safely place the device [7], and that adverse events are infrequent. The World Health Organization Technical Advisory Group (WHO TAG) reviewed eight published and unpublished studies of the PrePex device in January, 2013, and concluded that in ∼7% of clients the PrePex device could not be used because a tight foreskin precluded placement, that adverse events were ∼1.7% and that severe adverse events, mainly due to displacement or self-removal of the elastic ring, required urgent surgical intervention in 0.4% of cases [12].…”

Section: Introductionmentioning

confidence: 99%

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The Safety and Acceptance of the PrePex Device for Non-Surgical Adult Male Circumcision in Rakai, Uganda. A Non-Randomized Observational Study

et al. 2014

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ObjectivesTo assess the safety and acceptance of the PrePex device for medical male circumcision (MMC) in rural Uganda.MethodsIn an observational study, HIV-uninfected, uncircumcised men aged 18 and older who requested elective MMC were informed about the PrePex and dorsal slit methods and offered a free choice of their preferred procedure. 100 men received PrePex to assess preliminary safety (aim 1). An additional 329 men, 250 chose PrePex and 79 chose Dorsal slit, were enrolled following approval by the Safety Monitoring Committee (aim 2). Men were followed up at 7 days to assess adverse events (AEs) and to remove the PrePex device. Wound healing was assessed at 4 weeks, with subsequent weekly follow up until completed healing.ResultsThe PrePex device was contraindicated in 5.7% of men due to a tight prepuce or phimosis/adhesions. Among 429 enrolled men 350 (82.0%) got the PrePex device and 79 (18.0%) the dorsal slit procedure. 250 of 329 men (76.0%) who were invited to choose between the 2 procedures chose Prepex. There were 9 AEs (2.6%) with the PrePex, of which 5 (1.4%) were severe complications, 4 due to patient self-removal of the device leading to edema and urinary obstruction requiring emergency surgical circumcision, and one due to wound dehiscence following device removal. 71.8% of men reported an unpleasant odor prior to PrePex removal. Cumulative rates of completed wound healing with the PrePex were 56.7% at week 4, 84.8% week 5, 97.6% week 6 and 98.6% week 7, compared to 98.7% at week 4 with dorsal slit (p<0.0001).ConclusionThe PrePex device was well accepted, but healing was slower than with dorsal slit surgery. Severe complications, primarily following PrePex self-removal, required rapid access to emergency surgical facilities. The need to return for removal and delayed healing may increase Program cost and client burden.

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Section: Discussionsupporting

confidence: 89%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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The Safety and Acceptance of the PrePex Device for Non-Surgical Adult Male Circumcision in Rakai, Uganda. A Non-Randomized Observational Study

et al. 2014

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“…Several technology developers are incorporating similar approaches or alternative methods for global health technology development. [55][56][57][58] Donors and global health policymakers need to understand in detail how these technologies are generated and to extract best practices/lessons learned to better foster development of sustainable global health technologies for resourcelimited settings.…”

Section: Discussionmentioning

confidence: 99%

Developing sustainable global health technologies: Insight from an initiative to address neonatal hypothermia

Gupta

Patel

Murty

et al. 2014

J Public Health Pol

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Relative to drugs, diagnostics, and vaccines, efforts to develop other global health technologies, such as medical devices, are limited and often focus on the short-term goal of prototype development instead of the long-term goal of a sustainable business model. To develop a medical device to address neonatal hypothermia for use in resource-limited settings, we turned to principles of design theory: (1) define the problem with consideration of appropriate integration into relevant health policies, (2) identify the users of the technology and the scenarios in which the technology would be used, and (3) use a highly iterative product design and development process that incorporates the perspective of the user of the technology at the outset and addresses scalability. In contrast to our initial idea, to create a single device, the process guided us to create two separate devices, both strikingly different from current solutions. We offer insights from our initial experience that may be helpful to others engaging in global health technology development.

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“…Following clinical studies of PrePex in Rwanda [5,6,7] and other unpublished reports, WHO pre-qualified PrePex for use in national VMMC programs [8]. Pilot implementation studies of the device were then conducted, including one conducted in routine service delivery by our team in western Kenya [9].…”

Section: Introductionmentioning

confidence: 99%

Unexpected Complications Following Adult Medical Male Circumcision Using the PrePex Device

et al. 2015

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Introduction: In this study, we describe and depict unexpected sequelae of adult medical male circumcision (MMC) using the PrePex device. Materials and Methods: The PrePex system is an elastic compression device for adult MMC. The device is well studied, has been pre-qualified by the World Health Organization (WHO), and its use is being scaled-up in African countries targeted by WHO. We conducted a PrePex implementation study in routine service delivery among 427 men in the age range of 18-49 in western Kenya. We captured penile photographs to create a record of adverse events (AEs) and to monitor healing. Several unexpected AEs ensued, including some that have not been reported in other PrePex studies. We describe and depict those unexpected complications and resulting treatments to alert circumcision providers in the relevant areas. Results: We observed 5 device displacements (1.2%); 3 cases of early sloughing of foreskin tissue (0.7%) among men with long foreskins; 2 cases of a long foreskin obstructing urine flow, as it became dry and necrotic (0.5%); and 2 cases of insufficient foreskin removal caused by invagination for which surgical completion was necessary (0.5%). All of the participants healed completely by day 42 post-circumcision or shortly thereafter. Conclusion: The potential for these complications should be incorporated into PrePex training programs. Integration of devices into MMC programs in medically underserved areas requires the availability of prompt surgical intervention for some sequelae, particularly displacement events.

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One-Arm, Open-Label, Prospective, Cohort Field Study to Assess the Safety and Efficacy of the PrePex Device for Scale-Up of Nonsurgical Circumcision When Performed by Nurses in Resource-Limited Settings for HIV Prevention

Cited by 37 publications

References 7 publications

The Safety and Acceptance of the PrePex Device for Non-Surgical Adult Male Circumcision in Rakai, Uganda. A Non-Randomized Observational Study

The Safety and Acceptance of the PrePex Device for Non-Surgical Adult Male Circumcision in Rakai, Uganda. A Non-Randomized Observational Study

Developing sustainable global health technologies: Insight from an initiative to address neonatal hypothermia

Unexpected Complications Following Adult Medical Male Circumcision Using the PrePex Device

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