An interventional study of Copper impregnated wound dressing and Normal wound dressing in Cesarean Section; Infection, Perineal Infection and Wound Infection, sponsored by Croydon Health Services NHS Trust. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-03.
Sponsored by Croydon Health Services NHS Trust · Not applicable, Interventional, and Prevention
Among 21 studies in Surgical Wound Infection with a site in United Kingdom — 2 open to participants now, 2 under way, 1 of them phase 3. Surgical Wound Infection · United Kingdom.
Among the 21 studies in Surgical Wound Infection with a site in United Kingdom, this one is the 3rd largest by enrollment of the 13 interventional ones that give a count, is one of 4 that started in 2016, is one of 9 with no phase, and was the 10th registered.
745 studies on the registry are indexed under Surgical Wound Infection; 151 are open to participants now.
Browse Surgical Wound Infection studies →2 of the 21 studies in Surgical Wound Infection with a site in United Kingdom are open now. Recruiting first, the newest first:
Guy's and St Thomas' NHS Foundation Trust · Sites in United Kingdom
Ages 16+
East Lancashire Hospitals NHS Trust · Sites in United Kingdom
Ages 18+
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 84 Surgical Wound Infection studies recruiting now, 60 (71%) set no upper age limit and 16 (19%) stop at 75 or younger; 12 take children under 18; 14 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 4 started in 2016.
This study's enrollment of 774 is above the median of 200 across 581 interventional studies indexed under Surgical Wound Infection.
Median enrollment 211 across the 13 interventional studies, 2,552 across the 8 observational. Of the 15 that completed or were terminated, 2 (13%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 21 have an industry lead sponsor. The 10 most frequent:
Croydon Health Services NHS Trust is the lead sponsor of 3 studies on the registry; none are open to participants now.
Croydon Health Services NHS Trust has 1 study filed under Surgical Wound Infection — fewer than ten, so there is no comparison to draw.
1 of the studies in Surgical Wound Infection with a site in United Kingdom that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05964140Phase 3East Lancashire Hospitals NHS TrustThe MANTRA Trial (MANdibular TRauma and Antibiotic Use) | 2027-06-30 |
Among the 21 studies in Surgical Wound Infection with a site in United Kingdom, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
745 studies on the registry are indexed under Surgical Wound Infection; 151 are open to participants now.
This study's enrollment of 774 is above the median of 200 across 581 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →Croydon Health Services NHS Trust is the lead sponsor of 3 studies on the registry; none are open to participants now.
Compared within Surgical Wound Infection, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Wound dressing impregnated with 3% copper oxide ions, to be applied for 7 days after caesarean section
Other: Copper impregnated wound dressing
Wound dressing without copper, to be applied for 7 days after caesarean section
Other: Normal wound dressing
Maternity pads impregnated with 3% copper oxide ions, to be used for 14 days after delivery
Other: Copper impregnated maternity pads
Maternity pads without copper, to be used for 14 days after delivery
Other: Normal maternity pads
Copper impregnated wound dressing
Normal wound dressing
Copper impregnated maternity pads
Normal maternity pads
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
Time frame: 30 days
Length of hospitalisation
Length of in hospital stay following child birth
Time frame: 30 days
Pain score
Visual Analog Scale for wound pain
Time frame: 7, 14 and 30 days after delivery
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2016 to primary completion in Oct 2017, 21 months.
Of 201 non-industry interventional studies with no phase under Surgical Wound Infection, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 21 months is below that.
Counting every sponsor, half of 208 studies reached it within 24 months; a quarter within 12 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Croydon Health Services NHS Trust