Dataset Information

Sutureless Adult Voluntary Male Circumcision with Topical Anesthetic: A Randomized Field Trial of Unicirc, a Single-Use Surgical Instrument.

ABSTRACT:

Introduction

The World Health Organization has solicited rapid and minimally invasive techniques to facilitate scale-up of voluntary medical male circumcision (VMMC).

Study design

Non-blinded randomized controlled field trial with 2:1 allocation ratio.

Participants

75 adult male volunteers.

Setting

Outpatient primary care clinic.

Intervention

Open surgical circumcision under local anesthetic with suturing vs. Unicirc disposable instrument under topical anesthetic and wound sealing with cyanoacrylate tissue adhesive.

Primary outcome

Intraoperative duration.

Secondary outcomes

Intraoperative and postoperative pain; adverse events; time to healing; patient satisfaction; cosmetic result.

Results

The intraoperative time was less with the Unicirc technique (median 12 vs. 25 min, p < 0.001). Wound healing and cosmetic results were superior in the Unicirc group. Adverse events were similar in both groups.

Conclusions

VMMC with Unicirc under topical anesthetic and wound sealing with cyanoacrylate tissue adhesive is rapid, heals by primary intention with superior cosmetic results, and is potentially safer and more cost-effective than open surgical VMMC.

Trial registration

Clinicaltrials.gov NCT02443792.

SUBMITTER: Shenje J

PROVIDER: S-EPMC4907451 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Sutureless Adult Voluntary Male Circumcision with Topical Anesthetic: A Randomized Field Trial of Unicirc, a Single-Use Surgical Instrument.

Shenje Justin J Millard Peter S PS

PloS one 20160614 6

<h4>Introduction</h4>The World Health Organization has solicited rapid and minimally invasive techniques to facilitate scale-up of voluntary medical male circumcision (VMMC).<h4>Study design</h4>Non-blinded randomized controlled field trial with 2:1 allocation ratio.<h4>Participants</h4>75 adult male volunteers.<h4>Setting</h4>Outpatient primary care clinic.<h4>Intervention</h4>Open surgical circumcision under local anesthetic with suturing vs. Unicirc disposable instrument under topical anesthe ...[more]

PMID: 27299735

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Project description:As an HIV prevention strategy, the scale-up of voluntary medical male circumcision (VMMC) is underway in 14 countries in Africa. For prevention impact, these countries must perform millions of circumcisions in adolescent and adult men before 2015. Although acceptability of VMMC in the region is well documented and service delivery efforts have proven successful, countries remain behind in meeting circumcision targets. A better understanding of men's VMMC-seeking behaviors and experiences is needed to improve communication and interventions to accelerate uptake. To this end, we conducted semi-structured interviews with 40 clients waiting for surgical circumcision at clinics in Zambia. Based on Stages of Change behavioral theory, men were asked to recount how they learned about adult circumcision, why they decided it was right for them, what they feared most, how they overcame their fears, and the steps they took to make it to the clinic that day. Thematic analysis across all cases allowed us to identify key behavior change triggers while within-case analysis elucidated variants of one predominant behavior change pattern. Major stages included: awareness and critical belief adjustment, norming pressures and personalization of advantages, a period of fear management and finally VMMC-seeking. Qualitative comparative analysis of ever-married and never-married men revealed important similarities and differences between the two groups. Unprompted, 17 of the men described one to four failed prior attempts to become circumcised. Experienced more frequently by older men, failed VMMC attempts were often due to service-side barriers. Findings highlight intervention opportunities to increase VMMC uptake. Reaching uncircumcised men via close male friends and female sex partners and tailoring messages to stage-specific concerns and needs would help accelerate men's movement through the behavior change process. Expanding service access is also needed to meet current demand. Improving clinic efficiencies and introducing time-saving procedures and advance scheduling options should be considered.

Project description:IntroductionMonitoring clinical safety of voluntary medical male circumcision (VMMC) is critical to minimize risk as VMMC programs for HIV prevention are scaled. This cross-sectional analysis describes the adverse event (AE) profile of a large-scale, routine VMMC program and identifies factors associated with the development, severity, and timing of AEs to provide recommendations for program quality improvement.Materials and methodsFrom 2015-2018 there were 28,990 circumcisions performed in International Training and Education Center for Health (I-TECH) supported regions of Namibia in collaboration with the Ministry of Health and Social Services. Two routine follow-up visits after VMMC were scheduled to identify clients with AEs. Summary statistics were used to describe characteristics of all VMMC clients and the subset who experienced an AE. We used chi-square tests to evaluate associations between AE timing, patient age, and other patient and AE characteristics. We used a logistic regression model to explore associations between patient characteristics and AE severity.ResultsOf the 498 clients with AEs (AE rate of 1.7%), 40 (8%) occurred ≤2 days, 262 (53%) occurred 3-7 days, 161 (32%) between day 8 and 14, and 35 (7%) were ≥15 days post-VMMC. Early AEs (on or before day 2) tended to be severe and categorized as bleeding, while infections were the most common AEs occurring later (p<0.001). Younger clients (aged 10-14 years) experienced more infections, whereas older clients experienced more bleeding (p<0.001).ConclusionsAlmost 40% of AEs occurred after the second follow-up visit, of which 179 (91%) were infections. Improvements in pre-surgical and post-surgical counselling and post-operative educational materials encouraging clients to seek care at any time, adoption of alternative follow-up methods, and the addition of a third follow-up visit may improve outcomes for patients. Enhancing post-surgical counselling and emphasizing wound care for younger VMMC clients and their caregivers could help mitigate elevated risk of infection.

Dataset Information

Sutureless Adult Voluntary Male Circumcision with Topical Anesthetic: A Randomized Field Trial of Unicirc, a Single-Use Surgical Instrument.

Introduction

Study design

Participants

Setting

Intervention

Primary outcome

Secondary outcomes

Results

Conclusions

Trial registration

Publications

Sutureless Adult Voluntary Male Circumcision with Topical Anesthetic: A Randomized Field Trial of Unicirc, a Single-Use Surgical Instrument.

Similar Datasets

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