Treatment of pediatric multilevel cervical spine fractures in resource-limited settings: a case report.

AIM OF THE STUDY: The main purpose of this study was to highlight the therapeutic approach of pediatric multilevel noncontiguous cervical spine fractures in resource-limited settings. CASE PRESENTATION: We report the case of a 15-year-old teenager with C1, C2, C4, C6, and C7 fractures following fall from height treated with a modified external fixator. At final follow-up, he fully recovered neurologic functions with bone healing. CONCLUSION: The modified external fixator is a therapeutic modality for pediatric multilevel noncontiguous cervical spine fractures.

Cost Analysis of Adult Male Circumcision with the PrePex Device versus Surgery in Rwanda.

In this study from Rwanda, voluntary adult male circumcision costs 33% less with trained nurses using the PrePex device compared with physician-nurse teams performing dorsal-slit surgery. These cost savings and the documented safety, speed, and efficacy of the PrePex procedure, serve Rwanda's HIV prevention program.

Assessing Odor Level when Using PrePex for HIV Prevention: A Prospective, Randomized, Open Label, Blinded Assessor Trial to Improve Uptake of Male Circumcision.

The PrePex is a WHO--prequalified medical device for adult male circumcision for HIV prevention. The Government of Rwanda was the first country to implement the PrePex device and acts as the leading center of excellence providing training and formal guidelines. As part of the Government's efforts to improve PrePex implementation, it made efforts to improve the psychological acceptability of device by men, thus increasing uptake with VMMC in sub-Saharan Africa. Some men who underwent the PrePex procedure complained of foreskin odor while wearing the PrePex 3-7 days after it was placed. This complaint was identified as potential risk for uptake of the device. Researchers from Rwanda assumed there is a possible relation between the level of foreskin odor and patient foreskin hygiene technique. The Government of Rwanda decided to investigate those assumptions in a scientific way and conduct a trial to test different hygiene-cleaning methods in order to increase the acceptability of PrePex and mitigate the odor concern. The main objective of the trial was to compare odor levels between three arms, having identical personal hygiene but different foreskin hygiene techniques using either clear water with soap during a daily shower, soapy water using a syringe, or chlorhexidine using a syringe. One hundred and one subjects were enrolled to the trial and randomly allocated into three trial arms. Using chlorhexidine solution daily almost completely eliminated odor, and was statistically significant more effective that the other two arms. The trial results suggest that odor from the foreskin, while wearing the PrePex device, could be related to the growth of anaerobic bacteria, which can be prevented by a chlorhexidine cleaning method. This finding can be used to increase acceptability by men when considering PrePex as one of the leading methods for HIV prevention in VMMC programs.

Skills training of health workers in the use of a non surgical device (PrePex) for adult Safe Male Circumcision.

BACKGROUND: Safe Male Circumcision (SMC) is a proven approach for partial protection of men from acquisition of HIV infection. Several sub-Saharan African countries have a target to circumcise 80% of males aged 15 to 49. The use of devices such as PrePex would aid scaling up of SMC. Since most health workers would have no prior experience with use of devices, skills training is needed. This paper explores a skills transfer model at an urban site in Uganda. OBJECTIVE: To assess the practicability and feasibility of rapid short duration training for safe PrePex device use. METHODS: A prospective study, conducted over 8 weeks (August-October 2012) at International Hospital Kampala, an urban Kampala hospital, examining the performance of various health worker cadres after training in the use of a non-surgical device (PrePex). The prospective study obtained approval from the Makerere School of Medicine Research and Ethics Committee and the Uganda National Council of Science and Technology. If eligible, and after the subject signed the informed consent form, they were enrolled into the study. RESULTS: Ten health workers were successfully trained in use of PrePex during a 3 day non-residential on-the-job training course. After the first three days of training, the trained health workers performed 561 placements and 529 device removals successfully. Over all adverse events (AE) rates were below ≤ 2%; however, there were some differences in AE rates across the cadres trained but not significant (p>0.25 for moderate AEs). CONCLUSION: Rapid training for safe use of the PrePex device is feasible for the range of health workers available for SMC in resource limited settings, but among those with past SMC experience.

Adverse events profile of PrePex a non-surgical device for adult male circumcision in a Ugandan urban setting.

BACKGROUND: Safe Male Circumcision is a proven approach for partial HIV prevention. Several sub Saharan African countries have plans to reach a prevalence of 80% of their adult males circumcised by 2015. These targets require out of ordinary organization, demand creation, timely execution and perhaps the use of SMC devices. OBJECTIVE: To profile Adverse Events rate and acceptance of PrePex, a non surgical device for adult male circumcision. METHODS: A prospective study, conducted at International Hospital Kampala, Uganda, between August and October 2012. Ethical approval was obtained from Uganda National Council of Science and Technology. RESULTS: Of 1,040 men received to undergo SMC, 678 opted for PrePex, 36 were excluded at an initial physical examination screening. 642 were enrolled and consented, and another 17 were excluded before device placement. 625 underwent the procedure. Average age was 24 years (± 7). Twelve moderate AEs occurred among 10 participants 12/625, (1.9%). These were all reversible. Five had device displacement, one had an everted foreskin; five had bleeding after the device was removed and one had voiding difficulties. The majority (279 out of 300) of men interviewed complained of some pain within the week of placement. Mean pain score at device placement (using visual analogue scale) was 0.5, at device removal 4.5 and within 2 min of removal the pain score was 1.4. Over 70% of the devices were placed and removed by non-physician clinicians. Presented with a choice, 60% of men chose PrePex over surgical SMC. Close to 90% would recommend the device to their friends. Odour from the necrotic skin was a concern. Removals done 1-2 days earlier than day 7 were beneficial and conferred no extra risk. CONCLUSION: AEs of a moderate or severe nature associated with PrePex were low and reversible. PrePex is feasible for mass safe male circumcision scaling up.

HIV prevention: male circumcision comparison between a nonsurgical device to a surgical technique in resource-limited settings: a prospective, randomized, nonmasked trial.

BACKGROUND: Randomized controlled trial studies have shown that male circumcision (MC) can reduce the risk of HIV infection by 53%-60%. The Joint United Nations Program on HIV and AIDS announced a 5-year plan to voluntarily circumcise 20 million men by 2015. There are more than 38 million males in sub-Saharan Africa that could benefit from MC for HIV prevention by 2015. Surgical MC is impractical for nation-wide coverage in resource-limited settings. Rwanda intends to launch a voluntary MC program to reach 2 million adult men in 2 years, an unattainable goal with surgical MC. This study was designed to compare a new nonsurgical device with surgical MC to assess nonsurgical MC suitability for scale-up. METHODS: Prospective, randomized controlled trial in Rwanda in which the PrePex device was used for nonsurgical MC and the dorsal-slit method for surgical MC (ratio: 2:1). Subjects were healthy adult male volunteers aged 21-54 years. The primary endpoint, set by World Health Organization, was total MC procedure time. FINDINGS: Of 217 eligible subjects, 144 were randomized to the PrePex/nonsurgical arm and 73 to the surgical arm. All subjects were circumcised in 10 working days. Nonsurgical MC was bloodless, without anesthesia, sutures, or sterile setting and with mean procedure time of 3.1 minutes (skin to skin), was significantly shorter than mean surgical procedure time (15.4 minutes skin to skin) (P < 0.0001). There were no device-related adverse events. Healing time of the PrePex arm was longer than the surgical arm. CONCLUSION: PrePex, the nonsurgical MC, takes significantly less time than surgical, is as safe, does not require injections or sterile settings, is bloodless and seems to be suitable for nurses.

Safety and efficacy of the PrePex device for rapid scale-up of male circumcision for HIV prevention in resource-limited settings.

OBJECTIVE: To assess the safety and efficacy of the PrePex device for nonsurgical circumcision in adult males as part of a comprehensive HIV prevention program in Rwanda. METHODS: Single-center 6-week noncontrolled study in which healthy men underwent circumcision using the PrePex device, which employs fitted rings to clamp the foreskin, leading to distal necrosis. In the first phase of the study, the feasibility of the procedure was tested on 5 subjects in a sterile environment; in the main phase, an additional 50 subjects were circumcised in a nonsterile setting by physicians or a nurse. Outcome measures included the rate of successful circumcision, time to complete healing, pain, and adverse events. RESULTS: In the feasibility phase, all 5 subjects achieved complete circumcision without adverse events. In the main phase, all 50 subjects achieved circumcision with 1 case of diffuse edema after device removal, which resolved with minimal intervention. Pain was minimal except briefly during device removal (day 7 after placement in most cases). The entire procedure was bloodless, requiring no anesthesia, no suturing, and no sterile settings. Subjects had no sick/absent days associated with the procedure. Median time for complete healing was 21 days after device removal. There were no instances of erroneous placement and no mechanical problems with the device. CONCLUSION: The PrePex device was safe and effective for nonsurgical adult male circumcision without anesthesia or sterile settings and may be useful in mass circumcision programs to reduce the risk of HIV infection, particularly in resource-limited settings.