Management of Post-circumcision Ischemia Using Hyperbaric Oxygen Therapy

Sponsor
Aswan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05152511
Collaborator
(none)
23
1
43
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Hyperbaric oxygen therapy

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.

Study Design

Study Type:
Observational
Actual Enrollment :
23 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Management of Post-circumcision Ischemia
Actual Study Start Date :
Apr 1, 2017
Actual Primary Completion Date :
Oct 30, 2020
Actual Study Completion Date :
Oct 30, 2020

Arms and Interventions

Arm Intervention/Treatment
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.

Combination Product: 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.
Other Names:
  • Pentoxifylline
  • Outcome Measures

    Primary Outcome Measures

    1. post-circumcision complication [April 2017 and October 2020]

      early and late complication

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 6 Years
    Sexes Eligible for Study:
    Male
    Inclusion Criteria:
    • male children complained of penile ischaemia after circumcision.
    Exclusion Criteria:
    • other post-circumcision complication not include penile ischaemia

    • patients with chronic diseases.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sarah Magdy Abdelmohsen Cairo Egypt 11331

    Sponsors and Collaborators

    • Aswan University Hospital

    Investigators

    • Principal Investigator: Sarah M Abdelmohsen, Aswan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Magdy, Principal Investigator, Aswan University Hospital
    ClinicalTrials.gov Identifier:
    NCT05152511
    Other Study ID Numbers:
    • AswanUH3
    First Posted:
    Dec 10, 2021
    Last Update Posted:
    Dec 10, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Magdy, Principal Investigator, Aswan University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 10, 2021