Management of Post-circumcision Ischemia Using Hyperbaric Oxygen Therapy

NCT ID: NCT05152511

Last Updated: 2021-12-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 23 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2020-10-30

Brief Summary

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.

Detailed Description

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.

Conditions

Post-circumsion Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

All male children who had penile ischaemia after circumcision were included in the 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.

Hyperbaric oxygen therapy

Intervention Type: 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.

Interventions

Hyperbaric oxygen therapy

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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Pentoxifylline

Eligibility Criteria

Inclusion Criteria

• male children complained of penile ischaemia after circumcision.

Exclusion Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 6 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Aswan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Magdy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah M Abdelmohsen

Role: PRINCIPAL_INVESTIGATOR

Aswan University

Locations

Sarah Magdy Abdelmohsen

Cairo, , Egypt

Countries

Egypt

Other Identifiers

AswanUH3

Identifier Type: -

Identifier Source: org_study_id