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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03284749
Recruitment Status : Completed
First Posted : September 15, 2017
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Mr Abdul H Sultan, Croydon Health Services NHS Trust

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Cesarean Section; Infection Perineal Infection Wound Infection Surgical Site Infection Other: Copper impregnated wound dressing Other: Normal wound dressing Other: Copper impregnated maternity pads Other: Normal maternity pads Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 774 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All women are randomised to either the copper or the control group. Randomisation will be done separately for the caesarean section and vaginal delivery group.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: After inclusion all patients 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 patient will be blinded to the randomised group. Only the manufacturer will be aware of which group contains copper.
Primary Purpose: Prevention
Official Title: Randomised Controlled Trial on the Effect of Copper Impregnated Dressings and Maternity Pads on the Healing of Obstetric Wounds and Wound Infection
Actual Study Start Date : January 14, 2016
Actual Primary Completion Date : October 19, 2017
Actual Study Completion Date : December 19, 2017

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Length of hospitalisation [ Time Frame: 30 days ]
    Length of in hospital stay following child birth

  2. Pain score [ Time Frame: 7, 14 and 30 days after delivery ]
    Visual Analog Scale for wound pain


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03284749


Locations
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United Kingdom
Croydon Health Services NHS Trust
Croydon, United Kingdom, CR7 7YE
Sponsors and Collaborators
Croydon Health Services NHS Trust
Investigators
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Principal Investigator: Abdul H Sultan Croydon Health Services NHS Trust
  Study Documents (Full-Text)

Documents provided by Mr Abdul H Sultan, Croydon Health Services NHS Trust:
Study Protocol and Statistical Analysis Plan  [PDF] September 17, 2015
Informed Consent Form  [PDF] January 12, 2016

More Information
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Publications:

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Responsible Party: Mr Abdul H Sultan, Consultant Obstetrician and Gynaecologist, Croydon Health Services NHS Trust
ClinicalTrials.gov Identifier: NCT03284749    
Other Study ID Numbers: 15/07
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mr Abdul H Sultan, Croydon Health Services NHS Trust:
Copper Oxide
Antibiotic Resistance
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Surgical Wound Infection
Wound Infection
Wounds and Injuries
Disease Attributes
 Pathologic Processes
Postoperative Complications
Copper
Trace Elements
Micronutrients
Physiological Effects of Drugs