Surgical Site Infection Clinical Trial
— ECHOOfficial title:
Randomised Controlled Trial on the Effect of Copper Impregnated Dressings and Maternity Pads on the Healing of Obstetric Wounds and Wound Infection
Verified date | August 2018 |
Source | Croydon Health Services NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 774 |
Est. completion date | December 19, 2017 |
Est. primary completion date | October 19, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Croydon Health Services NHS Trust | Croydon |
Lead Sponsor | Collaborator |
---|---|
Croydon Health Services NHS Trust |
United Kingdom,
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post Discharge Questionnaire (PDQ) | 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 | Length of hospitalisation | Length of in hospital stay following child birth | 30 days | |
Secondary | Pain score | Visual Analog Scale for wound pain | 7, 14 and 30 days after delivery |
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