Randomised Controlled Trial on the Effect of Copper Impregnated Dressings and Maternity Pads on the Healing of Obstetric Wounds and Wound Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 774
- 试验地点
- 2
- 主要终点
- Post Discharge Questionnaire (PDQ)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Copper impregnated wound dressing
Wound dressing impregnated with 3% copper oxide ions, to be applied for 7 days after caesarean section
干预措施: Copper impregnated wound dressing (Other)
Normal wound dressing
Wound dressing without copper, to be applied for 7 days after caesarean section
干预措施: Normal wound dressing (Other)
Copper impregnated maternity pads
Maternity pads impregnated with 3% copper oxide ions, to be used for 14 days after delivery
干预措施: Copper impregnated maternity pads (Other)
Normal maternity pads
Maternity pads without copper, to be used for 14 days after delivery
干预措施: Normal maternity pads (Other)
结局指标
主要结局
Post Discharge Questionnaire (PDQ)
时间窗: 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
次要结局
- Length of hospitalisation(30 days)
- Pain score(7, 14 and 30 days after delivery)
研究者
Mr Abdul H Sultan
Consultant Obstetrician and Gynaecologist
Croydon Health Services NHS Trust