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Completed

NCT Number: NCT05152511

Management of Post-circumcision Ischemia Using Hyperbaric Oxygen Therapy

Background: Post-circumcision penile ischaemia is a rare but destructive complication. Our goal is to present our experience in the management of children, who had different forms of penile ischaemia, complicating the routine ritual male circumcision.

Material and Methods: All male children who had post-circumcision penile ischaemia between April 2017 and October 2020 were included in the study. A special designed protocol for management of all cases includes a combination of early Pentoxifylline intervenes infusion with Hyperbaric Oxygen inhalation, early catheterization, and appropriate surgical debridement. Data were analyzed inclusively to patient age, the anesthesia method used, Monopolar diathermy usage, early presentation, method of circumcision and positive wound culture.

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Key information

Age range

1 month–6 year

Sex eligibility

Male

Study type

Observational

Primary location

Sarah Magdy Abdelmohsen

Cairo, 11331, Egypt

About this study

It is a cohort prospective study. All male children who had penile ischaemia after circumcision were included in the study between April 2017 and October 2020. A special designed protocol includes early admission of a child in Paediatric intensive care unit (PICU). Catheterization by suitable size silicon Foley's catheter appropriate for the age. IV Pentoxifylline in a dose of 10 mg/kg/day divided into 3 equal doses with good monitoring of its side effects mainly tachycardia and convulsions. IV 3rd generation cephalosporin with suitable doses according to the age and body weight. Hyperbaric Oxygen therapy is a specially designed cabinet for infants and neonates with a barometric pressure equal to 760 mmHg for 20 minutes daily, then gradually increase up to one hour daily for 5 days per week (fig. 1). The chamber was kept warm. The babies were fed before entering the chamber and if signs of hunger appear during therapy. The baby was continuously monitored with pulse oximeter. Older children are managed in the conventional Hyperbaric Oxygen chamber with the same regimen. Proper surgical debridement together with daily topic dressing with nitroglycerin ointment (2%). The treatment continued through the admission period. Follow up period range from 6 months up to 3 years.

Data were analyzed inclusively to patient age, the type of medical provider who performed the circumcision, the technique of male circumcision, the anesthesia method used, if any Monopolar diathermy usage, wound suturing after MC, the duration of between male circumcision and presentation to our protocol, and the final condition of the patient at discharge and after 6 months.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male children complained of penile ischaemia after circumcision.

Exclusion criteria

  • other post-circumcision complication not include penile ischaemia
  • patients with chronic diseases.

Treatment and study plan

Hyperbaric oxygen therapy

Combination Product

Hyperbaric oxygen therapy is a specially designed cabinet for infants and neonates with a barometric pressure equal to 760 mmHg for 20 minutes daily, then gradually increase up to one hour daily for 5 days per week (fig. 1). The chamber was kept warm. The babies were fed before entering the chamber and if signs of hunger appear during therapy. The baby was continuously monitored with pulse oximeter. Older children are managed in the conventional Hyperbaric oxygen chamber with the same regimen.

Other names: Pentoxifylline

Primary outcomes

  1. post-circumcision complication

    Time frame: April 2017 and October 2020

    early and late complication

Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Official study title

Management of Post-circumcision Ischemia

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 10, 2021
Registry last updated
Dec 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.