Status:
COMPLETED
Effect of Copper on the Healing of Obstetric Wounds
Lead Sponsor:
Croydon Health Services NHS Trust
Conditions:
Cesarean Section; Infection
Perineal Infection
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The most common complication of vaginal delivery is perineal tearing with a prevalence of 85% and 70% will need suturing. The caesarean section rate worldwide is rising and the rate in Croydon Univers...
Detailed Description
This is a double blind randomised controlled pilot study to assess feasibility of copper impregnated wound dressings and maternity pads for the healing of obstetric wounds. All women having a caesarea...
Eligibility Criteria
Inclusion
- Aged 18 or over
- Delivered by caesarean section (emergency or elective), or vaginally, sustaining a perineal tear or episiotomy which needed to be sutured
- Ability to understand and read the content of the patient information sheet (in English, via an interpreter if needed and possible)
- Ability to give informed consent
Exclusion
- Inability to give consent
- Fetal or neonatal death or poor neonatal outcome
- Obstetric anal sphincter injuries
- Included in another study on postpartum infection
- Wilson's disease
- Allergy to copper
Key Trial Info
Start Date :
January 14 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2017
Estimated Enrollment :
774 Patients enrolled
Trial Details
Trial ID
NCT03284749
Start Date
January 14 2016
End Date
December 19 2017
Last Update
August 3 2018
Active Locations (1)
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1
Croydon Health Services NHS Trust
Croydon, United Kingdom, CR7 7YE