Clinical trial NCT03284749: Effect of Copper on the Healing of Obstetric Wounds
Official title: Randomised Controlled Trial on the Effect of Copper Impregnated Dressings and Maternity Pads on the Healing of Obstetric Wounds and Wound Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section; Infection
Perineal Infection
Wound Infection
Surgical Site Infection
Keywords: Copper Oxide
Antibiotic Resistance
Lead sponsor: Croydon Health Services NHS Trust
Sponsor class: OTHER
First posted: 2017-09-15
Enrollment: 774
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Post Discharge Questionnaire (PDQ)
timeFrame: 30 days
Secondary outcomes:
measure: Length of hospitalisation
timeFrame: 30 days
measure: Pain score
timeFrame: 7, 14 and 30 days after delivery
Other outcomes:
Locations:
city: Croydon
country: United Kingdom
facility: Croydon Health Services NHS Trust
Study officials:
affiliation: Croydon Health Services NHS Trust
name: Abdul H Sultan
role: PRINCIPAL_INVESTIGATOR
References:
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