Circumcision Device Research Articles

Device-based circumcision: advantages, choice of device and surgical technique

Introduction. Circumcision is one of the most common surgical procedures for men. WHO programs aimed at reducing HIV transmission have led to the development of various circumcision devices designed to standardize surgical techniques, reduce operating time and the number of complications.Objective. To examine available data on the efficacy and safety of different methods of device-based circumcision.Materials & methods. The results of a search in scientific databases such as eLibrary and PubMed were analyzed using the keywords: "circumcision", "circumcision device", and "phimosis". The search was conducted without regard to date or language of publication. After reviewing the literature, 25 articles were selected that best reflect the topic of device-assisted circumcision for further analysis.Results. Device-based circumcision can significantly reduce surgical time, regardless of the type of device used. Device-based circumcision is the safe treatment method; however, it may have a higher incidence of adverse events compared to the standard circumcision technique. The use of self-suturing devices is preferred over ring devices due to fewer complications, better cosmetic results, and greater patient satisfaction. The article is supplemented with a description of the surgical technique of various options for device-based circumcision.Conclusion. Device-based circumcision is effective and safe treatment method on an outpatient basis, which successfully competes with conventional circumcision of the foreskin.

Comparative analysis of two methods in circumcision: a new disposable device versus classic sleeve technique

PurposeCircumcision is the most common surgical procedures performed in males. Medical circumcision is recommended for diseases such as phimosis, paraphimosis, balanoposthitis and common urinary tract infections, although there is no exact indication. Conversely, Jewish and Muslim individuals commonly undergo circumcision regardless of medical necessity. Circumcision devices are designed to shorten surgery time, achieve an aesthetic appearance and ensure safe surgery. The aim of this study is to evaluate the effectiveness of the NeoAlis clamp, a disposable circumcision device, by comparing it with the sleeve technique in children.Materials and methodsBetween 2017 and 2023, retrospective evaluation of 2626 patients who underwent circumcision using either the NeoAlis clamp (group 1) or the sleeve technique (group 2) was conducted. Operation time, results, cost, complications were compared between the two groups.ResultsThe study encompassed 2626 patients who fulfilled the inclusion criteria. Group 1 comprised 2403 patients, whereas Group 2 consisted of 223 patients. The overall complication rate, as denoted by n = 47, was 1.7%. Group 1 operation time was shorter than group 2. Bleeding, the most feared complication in the early period, was higher in the second group. No statistically significant difference was observed between the two groups regarding cost comparison.ConclusionThe primary concern during circumcision is to avoid complications related to general anesthesia in newborns and infants. The use of disposable ring devices has been facilitated by the shorter operation time and the absence of the need for sutures when performing circumcision under local anesthesia. However, knowledge of advanced surgical circumcision techniques is necessary in cases of bleeding and inappropriate ring placement.

The Difference in the Effectiveness of Removing the Modern Super Ring Circumcision Device with Olive Drops and Aloe Vera Ointment Treatment

Background: Circumcision using the Super Ring method requires removing the ring after the wound is dry by treating used the principle of moisture. Purpose: The aim of this study was to determine the difference in the effectiveness of removing the Modern Super Ring Circumcision Device with Olive Drops and Aloe vera Ointment treatment. Method: The research design used Pre-Experimental with a post test only approach, used Accidental Sampling with a research sample of 32 respondents and tested using the Mann Whitney test. The majority of 14 respondents (87.4%) removed the circumcision ring with aloe vera ointment treatment in less than 10 days, while the majority of 15 respondents (93.7%) received circumcision ring removal with olive drops in more than 10 days. Results: The results of the Mann Whitney Test obtained a p value of 0.000, indicating that there was a significant difference, aloe vera ointment showed that the average time required to remove the Circumcision Ring was faster than olive drops. Conclusion: Aloe vera ointment made the wound environment more moist, thereby speeding up the wound healing process.

Analisis patentability alat sunat sekali pakai pada pengembangan desain industri A00202202524

Industrial Design A00202202524, is about a circumcision device, which is called a modern circumcision device or a disposable circumcision device. The tool was designed taking into account the creator's experience, prior art, functional review and the anatomy in which the tool is used. Design development has been obtained and the product has been tested with good success. As a follow-up, we want to know the patent ability of the new design. The method used is a search of the closest related patents as a comparison document, both Indonesian and international. Analysis of similarities and differences between the invention product and the comparison document or prior art. From the patents found, 5 Indonesian patents and 8 international patents were selected. Indonesia. The conclusions obtained are: the product/invention is different from the comparison documents. Certain features of findings or creations or inventions are the answer to a technical problem, which has an invention step, and is new. Such creations or inventions have the potential to obtain a patent if the draft patent is properly formulated

Comparative analysis on the outcomes in circumcising children using modified Chinese ShangRing and conventional surgical circumcision

To compare the differences and outcomes of surgical procedures, clinical effect, complications and patients' satisfaction between disposable oval-shaped circumcision device (Modified Chinese ShangRing series, Kiddie love®) and conventional circumcision in the treatment of children with phimosis or redundant prepuce. The clinical data were retrospectively analyzed in 114 children with phimosis or redundant foreskin undergone circumcision using a disposable oval-shaped circumcision device, a modified Chinese ShangRing series, Kiddie Love® (Kiddie Love group) in our hospital between January 2018 and February 2020, and another 114 children with similar conditions circumcised by conventional surgical procedure before January 2018 (conventional group). The two groups were compared regarding the operative time, intraoperative blood loss, postoperative pain scores, healing time, the incidence of complications and guardian's satisfaction. Circumcision was successfully completed in children in both groups. The operative time, intraoperative blood loss, postoperative pain scoring in 24h by VAS, pain at the removal of the device or stitches and wound healing were (6.4 ± 1.6) min, (34.1 ± 6.4) min; (0.7 ± 0.2) ml, (2.6 ± 0.6) ml; (2.2 ± 1.0) points, (1.3 ± 0.5) points; (23.7 ± 3.9)day, (15.9 ± 2.8)day, respectively for Kiddie Love group and conventional group(either P < 0.05 or P > 0.05). The two groups were significantly different in the incidence of hematoma, edema and incision dehiscenceyet were insignificant in incision infection. Children in both groups were followed up from 6 to 31months (mean: 23months), and the satisfaction rate was 94.7% (108/114) in parents of the children circumcised by the ShangRing and 83.3% (95/114) in those of children treated by conventional circumcision (P < 0.05). Modified Chinese ShangRing, Kiddie Love®, has superiorities, including simpler procedure, shorter operative time, less blood loss, fewer complications, better cosmetic results and higher satisfaction of patients over conventional circumcision in the treatment of children with phimosis or redundant foreskin, and worthy of wider clinical recommendation.

Safety, acceptability, and feasibility of male circumcision using the alisklamp device

Greater than 20 surgical circumcision devices are available worldwide for male circumcision. These have been developed so as to decrease complications. The hemostasis system classifies these devices as crush, clamp or ligature. This study assessed the safety, acceptability, and feasibility of male neonatal circumcision using the Alisklamp device (AKD). The AKD is one of the latest medical devices designed for assisted circumcision. It takes less time to install, has a better complication rate, and has a better cosmetic appearance than conventional surgical circumcision. The study was divided into two sections: assessing the safety of the AKD and evaluating parents' satisfaction. Convenience sampling was used in this study. In the first section, a form was filled by operating pediatric surgeon for children whose parents agreed to participate in the study. In the second section, a total of 100 male children were included in the study based on the sample size guidelines of the World Health Organization. The circumcision was performed by an experienced pediatric surgeon following the manufacturer's instructions. The procedures were completed without AKD failure or unwelcome preputial loss. The results showed that 63.54% of the children were circumcised in their first four weeks of life. About 60.42% of the procedures were completed within 5-10min. Also, 95.83% of the children had no postoperative complications. Further, 90.63% of parents were satisfied with the AKD and willing to recommend it to others. During the follow-up, all of the children's parents were pleased with the cosmetic and final results of the AKD. In conclusion, the AKD has an outstanding protection profile suitable for male circumcision procedures.

ShangRing versus Mogen clamp for early infant male circumcision in eastern sub-Saharan Africa: a multicentre, non-inferiority, adaptive, randomised controlled trial

Use of medical devices represents a unique opportunity to facilitate scale-up of early infant male circumcision (EIMC) across sub-Saharan Africa. The ShangRing, a circumcision device prequalified by WHO, is approved for use in adults and adolescents and requires topical anaesthesia only. We aimed to investigate the safety and efficacy of the ShangRing versus the Mogen clamp for EIMC in infants across eastern sub-Saharan Africa. In this multicentre, non-inferiority, open-label, randomised controlled trial, we enrolled healthy male infants (aged <60 days), with a gestational age of at least 37 weeks and a birthweight of at least 2·5 kg, from 11 community and referral centres in Kenya, Tanzania, and Uganda. Infants were randomly assigned (1:1) by a computer-generated text message service to undergo EIMC by either the ShangRing or the Mogen clamp. The primary endpoint was safety, defined as the number and severity of adverse events (AEs), analysed in the intention-to-treat population (all infants who underwent an EIMC procedure) with a non-inferiority margin of 2% for the difference in moderate and severe AEs. This trial is registered with Clinical. gov, NCT03338699, and is complete. Between Sept 17, 2018, and Dec 20, 2019, a total of 1420 infants were assessed for eligibility, of whom 1378 (97·0%) were enrolled. 689 (50·0%) infants were randomly assigned to undergo EIMC by ShangRing and 689 (50·0%) by Mogen clamp. 43 (6·2%) adverse events were observed in the ShangRing group and 61 (8·9%) in the Mogen clamp group (p=0·078). The most common treatment-related AE was intraoperative pain (Neonatal Infant Pain Scale score ≥5), with 19 (2·8%) events in the ShangRing and 23 (3·3%) in the Mogel clamp group. Rates of moderate and severe AEs were similar between both groups (29 [4·2%] in the ShangRing group vs 30 [4·4%] in the Mogen clamp group; difference -0·1%; one-sided 95% CI upper limit of 1·7%; p=0·89). No treatment-related deaths were reported. Use of the ShangRing device for EIMC showed safety, achieved high caregiver satisfaction, and did not differ from the Mogen clamp in other key measures. The ShangRing could be used by health systems and international organisations to further scale up EIMC across sub-Saharan Africa. Bill & Melinda Gates Foundation.

Circumcision devices versus standard surgical techniques in adolescent and adult male circumcisions: a Cochrane review.

ObjectivesTo assess the effects of device‐based circumcisions compared with standard surgical techniques in adolescent and adult males (10 years old and above).MethodsWe performed a comprehensive search with no restrictions to the language of publication or publication status. We included randomised controlled trials (RCTs) of device‐based circumcisions compared to standard surgical dissection‐based circumcision conducted by health professionals in a medical setting. We reported study results as risk ratios (RRs) or mean differences (MDs) using 95% confidence intervals (CIs) and a random‐effects model. We used the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to evaluate the overall certainty of the evidence for each outcome.ResultsA total of 18 trials met the inclusion criteria. These trials did not report severe adverse events (AEs; 11 trials, 3472 participants). There may be a slight increase in moderate AEs for devices compared to surgical techniques (RR 1.31, 95% CI 0.55–3.10; I 2 = 68%; 10 trials, 3370 participants; low‐certainty evidence); this corresponds to eight more (ranging from 15 fewer to 84 more) moderate AEs per 1000 participants. We are uncertain about the difference in mild AEs between groups when devices are used compared to surgical techniques (RR 1.09, 95% CI 0.44–2.72; I 2 = 91%; 10 trials, 3370 participants; very low‐certainty evidence).ConclusionsWe found no serious AEs using a circumcision device compared to surgical techniques. Still, they may slightly increase moderate AEs, and it is unclear whether there is a difference in mild AEs. High‐quality trials evaluating this intervention are needed to provide further certainty regarding the rates of AEs. Clinicians, patients, and policymakers can use these results combined with their contextual factors to inform the best approach that suits their healthcare settings.

Comparison of NeoAlis™ disposable circumcision device and sleeve technique in circumcision: Results from a referral health-care center in Turkey

Circumcision has been one of the most commonly performed surgical procedures worldwide since ancient times. Given the popularity of this procedure, the aim of this study was to evaluate the effectiveness, reliability, and results of circumcision performed using the NeoAlis™ clamp and compare them with those obtained using the sleeve technique. The results of 2259 patients circumcised using the two techniques were evaluated retrospectively. The patients who were circumcised using the plastic NeoAlis™ device were classified as group 1 and those circumcised using the sleeve technique were designated as group 2. The groups were compared in terms of operation time, results, cost, complications, and cosmetic satisfaction scores. A total of 1947 patients who met the inclusion criteria were included in the study. Group 1 consisted of 1454 patients, while group 2 comprised 493 patients. The total rate of complications, excluding bleeding in the form of oozing that stopped spontaneously, was 9.5% (n=185). In group 1, the operation time was shorter, tolerability of local anesthesia was higher, satisfaction questionnaire scores were higher, cost was lower, and rates of early adhesion and meatal stenosis were lower. All of these parameters were significantly different from those in group 2. Notably, secondary phimosis was significantly higher in group 1. Although the bleeding that stopped with follow-up was significantly higher in group 2, there was no significant difference between the groups in terms of bleeding that required surgical intervention. Our study, which reports the results of circumcisions performed using the NeoAlis clamp, has the largest sample size in the literature. Moreover, this is the only study in the literature wherein the results of sleeve circumcision, which is a time-tested surgical procedure, and the results of NeoAlis clamp circumcision, which we applied to a large number of patients, were compared with each other and with the literature. The retrospective design that focused on relatively short-term (one month) results is the major limitation of this study. Mass circumcision performed with a plastic clamp technique is safe, timesaving, easily teachable, and cosmetically advantageous.

MP67-06 RESULTS OF A RANDOMIZED CONTROLLED TRIAL OF SHANGRING VERSUS MOGEN CLAMP IN EARLY INFANT MALE CIRCUMCISION IN SUB-SAHARAN AFRICA

You have accessJournal of UrologyGlobal Health/Humanitarian (MP67)1 Sep 2021MP67-06 RESULTS OF A RANDOMIZED CONTROLLED TRIAL OF SHANGRING VERSUS MOGEN CLAMP IN EARLY INFANT MALE CIRCUMCISION IN SUB-SAHARAN AFRICA Quincy Nang, Spyridon Basourakos, Nahid Punjani, Omar All Hussein Al Awamlh, Kaylee Ho, Karla Ballman, Mark Barone, Quentin Awori, Daniel Ouma, Alice Christensen, Godfrey Kigozi, Marc Goldstein, Philip Li, and Richard Lee Quincy NangQuincy Nang More articles by this author , Spyridon BasourakosSpyridon Basourakos More articles by this author , Nahid PunjaniNahid Punjani More articles by this author , Omar All Hussein Al AwamlhOmar All Hussein Al Awamlh More articles by this author , Kaylee HoKaylee Ho More articles by this author , Karla BallmanKarla Ballman More articles by this author , Mark BaroneMark Barone More articles by this author , Quentin AworiQuentin Awori More articles by this author , Daniel OumaDaniel Ouma More articles by this author , Alice ChristensenAlice Christensen More articles by this author , Godfrey KigoziGodfrey Kigozi More articles by this author , Marc GoldsteinMarc Goldstein More articles by this author , Philip LiPhilip Li More articles by this author , and Richard LeeRichard Lee More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002028.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Early infant male circumcision (EIMC) is expected to help reduce HIV incidence and transmission given the compelling evidence in adults and adolescents. The ShangRing (SR) is the only World Health Organization prequalified circumcision device for males over 10 years requiring only topical peri-procedural anesthesia. We conducted the first large-scale randomized controlled trial in three sub-Saharan African countries comparing the safety and efficacy of the SR to current standard of care, the Mogen clamp (MoC) in early infants. METHODS: Healthy male infants from 11 sites in Kenya, Tanzania, and Uganda were equally randomized to EIMC with SR vs. MoC. Patients with congenital genitourinary anomalies, bleeding diathesis, or allergy to local anesthetics were excluded. Patients were followed for 42 days or until completion of healing. The primary endpoint was safety as defined by rates of adverse events. Secondary endpoints included procedural duration, pain (neonatal infant pain scale, NIPS), wound healing time, and parental satisfaction. RESULTS: A total of 1378 infant males were enrolled (SR: n=689, MoC: n=689). Patient groups were similar between devices, and within each country. The rates of adverse events were similar between the two groups (6.0% vs. 8.6%, p=0.08). No glandular injury (partial or total transection), severe wound infection, or hemorrhage were recorded. Post-operative mean NIPS scores in the SR and MC groups were 0.3±0.8 vs. 0.3±0.7 (p=0.29) respectively. All participants reached complete healing by post-operative day 42. No statistically significant differences were observed in supplemental local anesthetic rates (2.9% vs. 3%, p=1), procedural duration (mean 12.3±8.0 vs. 12.6±9.1 minutes, p=0.58), parental satisfaction with postoperative cosmesis (99.1% vs. 99.5%, p=0.60), and willingness to recommend circumcision (99.1% vs. 99.7%, p=0.22). CONCLUSIONS: EIMC with the SR is safe and does not significantly differ from the current standard of care. SR represents a unique opportunity to scale up EIMC services by implementing as a single-use device across all age ranges. Broad use of the SR, especially when targeted to males in early life, may further increase rates of circumcision in sub-Saharan Africa and subsequently lead to reductions in HIV transmission. Source of Funding: BMGF © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e511-e511 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Quincy Nang More articles by this author Spyridon Basourakos More articles by this author Nahid Punjani More articles by this author Omar All Hussein Al Awamlh More articles by this author Kaylee Ho More articles by this author Karla Ballman More articles by this author Mark Barone More articles by this author Quentin Awori More articles by this author Daniel Ouma More articles by this author Alice Christensen More articles by this author Godfrey Kigozi More articles by this author Marc Goldstein More articles by this author Philip Li More articles by this author Richard Lee More articles by this author Expand All Advertisement Loading ...

Circumcision devices versus standard surgical techniques in adolescent and adult male circumcisions.

Circumcision devices versus standard surgical techniques in adolescent and adult male circumcisions.

Is it safe to use a thermocautery device for circumcision? Examination of the histopathological changes emerging after thermocautery-assisted circumcisions.

Multiple number of techniques and devices have been described concerning circumcision method so far. One of them is thermocautery device, and it has been widely used. Although there is controversy that the penis may be damaged due to the heat generated during the use of the device, not enough histopathological studies have been conducted. We aimed to determine the histopathological changes in human foreskin caused by heat after circumcision with thermocautery and to demonstrate the safety of the use of a thermocautery-assisted circumcision. Forty-one patients were divided into two groups according to the thermal energy used during cutting with thermocautery as follows: high temperature (Group 1, n=22) and low temperature (Group 2, n=19). The effect of the heat intensity and depth of the coagulation necrosis produced with thermocautery-assisted circumcisions performed at low and high temperatures were evaluated. The difference between the groups was not statistically significant. Tissue damage is extremely limited in thermocautery-assisted circumcisions, even when it is used at high temperatures. The thermocautery device can be used for effective and safe circumcisions.

Is the PrePex device an alternative for surgical male circumcision in adolescents ages 13-17 years? Findings from routine service delivery during active surveillance in Zimbabwe.

BackgroundMale circumcision devices have the potential to accelerate adolescent voluntary medical male circumcision roll-out. Here, we present findings on safety, acceptability and satisfaction from active surveillance of PrePex implementation among 618 adolescent males (13–17 years) circumcised in Zimbabwe.MethodsThe first 618 adolescents consecutively circumcised from October 2015 to October 2016 using PrePex during routine service delivery were actively followed up. Outcome measures included PrePex uptake, attendance for post-circumcision visits and adverse events (AEs). A survey was conducted amongst 500 consecutive active surveillance clients to assess acceptability and satisfaction with PrePex.ResultsA total of 1,811 adolescent males were circumcised across the three PrePex active surveillance sites. Of these, 870 (48%) opted for PrePex but only 618/870 (71%) were eligible. Among the 618, two (0.3%) self-removals requiring surgery (severe AEs), were observed. Four (0.6%) removals by providers (moderate AEs) did not require surgery. Another 6 (1%) mild AEs were due to: bleeding (n = 2), swelling (n = 2), and infection (n = 2). All AEs resolved without sequelae. Adherence to follow-up appointments was high (97.7% attended 7 day visit). A high proportion (71.6%) of survey respondents said they heard about PrePex from a mobilizer; 49.8% said they chose PrePex because they wanted to avoid the pain associated with the surgical procedure/surgery on their penis. Acceptability and satisfaction with PrePex was high; 95.4% indicated willingness to recommend PrePex to peers. A majority (92%) reported experiencing pain when PrePex was being removed.ConclusionsActive surveillance of the first 618 adolescent males circumcised using PrePex suggests that the device is both safe and acceptable when used in routine service delivery among 13–17 year-olds. There is need to intensify specific demand generation activities for PrePex male circumcision among this group of males.

A systems-based assessment of the PrePex device adverse events active surveillance system in Zimbabwe.

BackgroundVoluntary Medical Male Circumcision (VMMC) is an effective method for HIV prevention and the World Health Organization (WHO) has recommended its expansion in 14 African countries with a high prevalence of HIV and low prevalence of male circumcision. The WHO has recently pre-qualified the PrePex device, a non-surgical male circumcision device, which reduces procedure time, can increase acceptability of VMMC, and can expand the set of potential provider cadres. The PrePex device was introduced in Zimbabwe as a way to scale-up VMMC services in the country. With the rapid scale-up of the PrePex device, as well as other similar devices, a strong surveillance system to detect adverse events (AE) is needed to monitor the safety profile of these devices. We performed a systems-based evaluation of the PrePex device AE active surveillance system in Zimbabwe.MethodsThe evaluation was based on the Centers for Disease Control and Prevention’s Updated Guidelines for Evaluating Public Health Surveillance Systems. We adapted these guidelines to fit our local context. The evaluation incorporated the review of the standard operating procedures and surveillance system documents. Additionally, structured, in-person interviews were performed with key stakeholders who were users of the surveillance system at various levels. These key stakeholders were from the Ministry of Health, implementing partners, and health facilities in Harare.ResultsClients were requested to return to the facility for follow-up on days 7, 14 and 49 after placement of the device. In the event of a severe AE, a standard report was generated by the health facility and relayed to the Ministry of Health Child and Care and donor agencies through predefined channels within 24 hours of diagnosis. Clinic staff reported difficulties with the amount of documentation required to follow up with clients and to report AEs. The surveillance system’s acceptability among users interviewed was high, and users were motivated to identify all possible AEs related to this device. The surveillance system was purely paper-based and both duplicate and discrepant reporting forms between sites were identified.ConclusionThe PrePex AE active surveillance system was well accepted among participants in the health system. However, the amount of documentation which was required to follow-up with patients was a major barrier within the system, and might lead to decreased timeliness and quality of reporting. A passive surveillance system supported by electronic reporting would improve acceptance of the program.

Clinical effects of circumcision device combine with elastic thread in posthetomy: analysis of 1362 cases

Objective To observe the clinical effects of the circumcision device combine with elastic thread for redundant prepuce and phimosis in posthetomy. Methods Clinical data of 1362 patients of redundant prepuce and phimosis underwent circumcision device combine with elastic thread were analyzed. The operative time, recovery time and main complication with the Shang Ring have been compared. Results All operations were successfully completed. Circumcision device combine with elastic thread group avoid ring-removal pain, the healing time and wound edema incidence was significantly reduced, as well as the pain after the operation. Conclusions Circumcision device combine with elastic thread has great advantages and wide introduction value. Key words: Circumcision, Male

Evaluation of the Safety of the Taraklamp Male Circumcision Device in Zambia

Background: Male circumcision has been proved to be an effective additional means of preventing transmission of the HIV virus from females to males in heterosexual relationships with efficacy of up to 60%. Many methods and devices for adult male circumcision have now been developed. However, there are still concerns on safety, duration of procedure, and public acceptability of these devices.&#x0D; Objectives: to assess safety, duration of procedure, complications, pain and public acceptability of the Taraklamp, male circumcision device, in adolescents and adult male circumcision in Zambia.&#x0D; Materials and Methods: we conducted a field study with 1,046 male adolescents and adults recruited from five district clinics. Prior to circumcision, participants were educated on benefits of circumcision while undergoing HIV counseling and screening. Duration of procedure was recorded, intra and postoperative pain was assessed and adverse events were documented for each participant. Levels of satisfaction with the procedure both from doctors’ and participants’ perspectives were also documented.&#x0D; Results: A total of 794 participants were circumcised using the TARAKLAMP device. The median time for circumcision was 4 minutes (IQR: 3-6 minutes; range: 1-24 minutes). Approximately 5 (0.6%) of the participants experienced postoperative pain and 12 (1.5%) experienced adverse events following the procedure. Despite this all participants found the procedure safe and acceptable, as did the doctors who carried out the procedure.&#x0D; Conclusions: the results from this study showed that the TARAKLAMP device is safe for medical male circumcision. Acceptability of the circumcision using the device was exceptional and it is possible to use the TARAKLAMP to roll out medical male circumcision in Zambia.

Evaluation of the safety of the Taraklamp male circumcision device in Zambia

&#x0D; Background: Male circumcision has been proved to be an effective additional means of preventing transmission of the HIV virus from females to males in heterosexual relationships with efficacy of up to 60%. Many methods and devices for adult male circumcision have now been developed. However, there are still concerns on safety, duration of procedure, and public acceptability of these devices.&#x0D; Objectives: to assess safety, duration of procedure, complications, pain and public acceptability of the Taraklamp, male circumcision device, in adolescents and adult male circumcision in Zambia.&#x0D; Materials and Methods: we conducted a field study with 1,046 male adolescents and adults recruited from five district clinics. Prior to circumcision, participants were educated on benefits of circumcision while undergoing HIV counseling and screening. Duration of procedure was recorded, intra and postoperative pain was assessed and adverse events were documented for each participant. Levels of satisfaction with the procedure both from doctors' and participants' perspectives were also documented.&#x0D; Results: A total of 794 participants were circumcised using the TARAKLAMP device. The median time for circumcision was 4 minutes (IQR: 3-6 minutes; range: 1- 24 minutes). Approximately 5 (0.6%) of the participants experienced postoperative pain and 12 (1.5%) experienced adverse events following the procedure. Despite this all participants found the procedure safe and acceptable, as did the doctors who carried out the procedure.&#x0D; Conclusions: the results from this study showed that the TARAKLAMP device is safe for medical male circumcision. Acceptability of the circumcision using the device was exceptional and it is possible to use the TARAKLAMP to roll out medical male circumcision in Zambia.&#x0D;

Prospective Observational Study of the ShangRing Device for Adult Medical Male Circumcision in a Routine Clinical Setting in Malawi.

We evaluated the safety and acceptability of the ShangRing device for male circumcision during routine clinical service delivery in Namitete, Malawi. We conducted a prospective observational study enrolling 500 HIV-negative men ages 18 to 49 years at St. Gabriel's Hospital. Participants returned for two follow-up visits: the removal visit (day 7 after placement) and the healing check visit (day 42 after placement). We assessed pain, adverse events (AEs), acceptability, and healing. 500 men were screened; 498 were circumcised using the ShangRing and comprised the analysis population. Seven participants (1.4%) experienced moderate AEs related to circumcision. 93% were judged to be completely healed at or before the day 42 visit; 6% were judged to be healed later than the day 42 visit; 5 participants (1.0%) were lost to follow-up. 98% of men stated they were very satisfied with the appearance of their circumcised penis, and 99.6% would recommend ShangRing circumcision to family/friends. Adult male circumcision using the ShangRing was safe with a low AE rate at this service delivery site. Acceptability factors were also favorable. Addition of the ShangRing device could be beneficial to achieving the goals of the circumcision program in Malawi.

Early Infant Male Circumcision in Cameroon and Senegal: Demand, Service Provision, and Cultural Context.

Male circumcision is almost universal in North and West Africa, and practiced for various reasons. Yet there is little documentation on service delivery, clinical procedures, policies, and programmatic strategies. The United Nations Children's Fund (UNICEF) commissioned country program reviews in 2014 to shed light on the delivery of male circumcision services for infants in Cameroon and Senegal. We conducted a policy desk review, key informant interviews, and focus group discussions at health centers and in communities. Between December 2014 and January 2015, we conducted 21 key informant interviews (13 with regional and district officers, 5 with national officers, and 3 with UNICEF officials) and 36 focus group discussions (6 with men, 6 with women, 12 with adolescent boys, and 12 with service providers). Some of the men and women were parents of the adolescents who participated in the focus group discussions. In the French-speaking areas, the focus group discussions were conducted in French through an accredited translator, audio recorded, and transcribed into English. All of the facilities we visited in Cameroon and Senegal offer medical male circumcision, with 10 out of 12 performing early infant male circumcision (EIMC) routinely. Neither country has policies, guidelines, or strategies for EIMC. The procedure is done mainly by untrained service providers, with some providers using modern circumcision devices. There are no key messages on EIMC for families; the increasing demand for EIMC is led by the community. Despite the absence of national policies and strategies, EIMC is routinely offered at all levels of the health care system in Cameroon and Senegal, mainly by untrained service providers. Improving circumcision services will require guidelines for EIMC and improvements in training, equipment, supply chains, recordkeeping, and demand creation.

Safety, Acceptability, and Feasibility of Early Infant Male Circumcision Conducted by Nurse-Midwives Using the AccuCirc Device: Results of a Field Study in Zimbabwe.

For prevention of HIV, early infant male circumcision (EIMC) needs to be scaled up in countries with high HIV prevalence. Routine EIMC will maintain the HIV prevention gains anticipated from current adult male circumcision initiatives. We present here the results of a field study of EIMC conducted in Zimbabwe. The study was observational and based on the World Health Organization (WHO) framework for clinical evaluation of male circumcision devices. We recruited parents of newborn male infants between August 2013 and July 2014 from 2 clinics. Nurse-midwives used the AccuCirc device to circumcise eligible infants. We followed participants for 14 days after EIMC. Outcome measures were EIMC safety, acceptability, and feasibility. We enrolled 500 male infants in the field study (uptake 11%). The infants were circumcised between 6 and 60 days postpartum. The procedure took a median of 17 minutes (interquartile range of 5 to 18 minutes). Mothers' knowledge of male circumcision was extensive. Of the 498 mothers who completed the study questionnaire, 91% knew that male circumcision decreases the risk of HIV acquisition, and 83% correctly stated that this prevention is partial. Asked about their community's perception of EIMC, 40% felt that EIMC will likely be viewed positively in their community; 13% said negatively; and 47% said the perception could be both ways. We observed 7 moderate or severe adverse events (1.4%; 95% confidence interval, 0.4% to 2.4%). All resolved without lasting effects. Nearly all mothers (99%) reported great satisfaction with the outcome, would recommend EIMC to other parents, and would circumcise their next sons. This first field study in sub-Saharan Africa of the AccuCirc device for EIMC demonstrated that EIMC conducted by nurse-midwives with this device is safe, feasible, and acceptable to parents.