Effect of Copper on the Healing of Obstetric Wounds (ECHO)

August 2, 2018 updated by: Mr Abdul H Sultan, Croydon Health Services NHS Trust

Randomised Controlled Trial on the Effect of Copper Impregnated Dressings and Maternity Pads on the Healing of Obstetric Wounds and Wound Infection

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 University Hospital is in the region of 25% of all deliveries. One in ten women will develop a wound infection of their perineal tear or caesarean section wound. Wound infection can cause pain, dehiscence, delayed wound healing, prolonged hospital stay, readmissions and interfere with a woman's ability to nurture their baby and enjoy motherhood. Copper has shown to have strong antimicrobial properties, with the ability to kill various bacteria including MRSA. It has also been shown that copper promotes new blood vessel formation and therefore enhance wound healing. This study is to investigate the effect of copper impregnated dressings and maternity pads on wound infection. Women will be randomised for a wound dressing or maternity pad with (study group) or without copper (control group). Both the clinician and the woman will be blinded to the randomised group. Wound infection will be assessed via a telephone questionnaire after 7, 14 and 30 days after delivery. When wound infection is suspected, based on the questionnaire, a swab of the wound site will be taken to detect the causative bacteria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 caesarean section or with perineal sutures after a vaginal delivery will be recruited from the antenatal clinic (in case of an elective caesarean section) or from the maternity wards within Croydon Health Services. All women will be given a patient information sheet describing the study prior to consent and will be giving adequate time to read the information before signing the Informed consent. Participants will be followed up via a telephone questionnaire 7, 14 and 30 days after the delivery.

Randomisation:

After inclusion all participants will be randomised for a wound dressing or maternity pad with (study group) or without copper (control group). The two sets of wound dressings and pads will be marked "A" or "B". Both the clinician and the participant will be blinded to the randomised group. Only the manufacturer will be aware of which group contains copper.

Copper impregnated dressings:

As soon as possible, but within 12 hours after primary closure of the caesarean section incision, the randomised study dressing will be applied. The two study dressings were equivalent to the dressing normally used within this Trust, except the foam of one set of dressings was impregnated with 3% copper oxide ions. The two sets of wound dressings were marked "A" and "B" and both the women and clinician were blinded to the randomised group. According to local protocol the wound dressing will be left intact for 7 days following surgery and will be renewed if necessary.

Copper impregnated maternity pads As soon as possible, but within 12 hours after suturing, women will be asked to wear the study maternity pads, which will be provided. The two sets of study maternity pads will be equivalent to the currently recommended pads, except that one set of pads will have a thin top layer of non-woven polyester fibres with 3% copper oxide ions permanently attached to it. Women will be asked to use the pads for 14 days.

Patient data, history and physical examination:

Demographic data such as age, ethnicity, height and weight will be collected as well as obstetric data and delivery details. Past medical history such as concomitant (chronic) diseases and the use of medications will be obtained. Wound infection will be assessed via a telephone questionnaire after 7, 14 and 30 days after delivery. The data will be stored in a secure room within Trust facilities. All electronic data will be stored within password protected IT system within the Trust, which is only accessible by the clinical and research team.

Questionnaire:

For the assessment of surgical site infection, the Post Discharge Questionnaire used by the HPC surgical site infection surveillance will be used, which is according to the worldwide used definition of surgical site infection by the CDC.

Statistical analysis Statistical analysis will be performed using SPSS version 20.0 or higher. Infection rates in the perineal tear group and the caesarean section group will be analysed seperately. The infection rates in the study group (with copper) will be compared to the control group and possible risk factors for infection will be explored. the Chi-Square will be used to analyse categorical variables and the T-test or Mann Whitney-U test will be used to analyse continuous variables. Multivariable logistic regression will be used to investigate risk factors for development of infection.

Sample size calculation Since the effect of copper on infection rates is currently unknown, we will conduct a pilot study for 12 months.

Study Type

Interventional

Enrollment (Actual)

774

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Croydon, United Kingdom, CR7 7YE
        • Croydon Health Services NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Copper impregnated wound dressing
Wound dressing impregnated with 3% copper oxide ions, to be applied for 7 days after caesarean section
Other: Copper impregnated wound dressing
Copper impregnated wound dressing
Placebo Comparator: Normal wound dressing
Wound dressing without copper, to be applied for 7 days after caesarean section
Other: Normal wound dressing
Normal wound dressing
Experimental: Copper impregnated maternity pads
Maternity pads impregnated with 3% copper oxide ions, to be used for 14 days after delivery
Other: Copper impregnated maternity pads
Copper impregnated maternity pads
Placebo Comparator: Normal maternity pads
Maternity pads without copper, to be used for 14 days after delivery
Other: Normal maternity pads
Normal maternity pads

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Discharge Questionnaire (PDQ)
Time Frame: 30 days

Questionnaire used by the HPC for surgical site infection surveillance. Using worldwide definition of surgical site infection by the CDC infection is present if one of the 6 criteria are met: 1) discharge pus AND antibiotics prescribed; 2) Clinical signs* AND wound dehiscence; 3) Clinical signs* AND antibiotics prescribed; 4)Uterine tenderness AND antibiotics prescribed; 5) Abdominal tenderness AND antibiotics prescribed; 6) Purulent discharge from uterus AND antibiotics prescribed.

* Clinical signs: at least 2 of pain, heat, redness or swelling
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospitalisation
Time Frame: 30 days
Length of in hospital stay following child birth
30 days
Pain score
Time Frame: 7, 14 and 30 days after delivery
Visual Analog Scale for wound pain
7, 14 and 30 days after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Croydon Health Services NHS Trust

Investigators

  • Principal Investigator: Abdul H Sultan, Croydon Health Services NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2016

Primary Completion (Actual)

October 19, 2017

Study Completion (Actual)

December 19, 2017

Study Registration Dates

First Submitted

September 13, 2017

First Submitted That Met QC Criteria

September 14, 2017

First Posted (Actual)

September 15, 2017

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 2, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15/07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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