Cesarean Section; InfectionECHONCT03284749
Effect of Copper on the Healing of Obstetric Wounds
A study testing Copper impregnated wound dressing, Normal wound dressing and Copper impregnated maternity pads in people with Cesarean Section; Infection and Perineal Infection, run by Croydon Health Services NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section; Infection, Perineal Infection, Wound Infection
- What is being tested?
- Copper impregnated wound dressing, Normal wound dressing and Copper impregnated maternity pads
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 774 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jan 2016to 19 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Croydon Health Services NHS Trust
Croydon, CR7 7YE
About this study
Official title: Randomised Controlled Trial on the Effect of Copper Impregnated Dressings and Maternity Pads on the Healing of Obstetric Wounds and Wound Infection
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.
Read the 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.
- Being tested
- Copper impregnated wound dressing, Normal wound dressing, Copper impregnated maternity pads, Normal maternity pads
- Keywords
- Copper Oxide, Antibiotic Resistance
- Medical subject headings
- Infections, Wound Infection, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copper impregnated wound dressingOther
Copper impregnated wound dressing
Normal wound dressingOther
Normal wound dressing
Copper impregnated maternity padsOther
Copper impregnated maternity pads
Normal maternity padsOther
Normal maternity pads
| Study group | Role | What they receive |
|---|---|---|
| Copper impregnated wound dressing | Experimental | Wound dressing impregnated with 3% copper oxide ions, to be applied for 7 days after caesarean section Receives: Other: Copper impregnated wound dressing |
| Normal wound dressing | Placebo comparator | Wound dressing without copper, to be applied for 7 days after caesarean section Receives: Other: Normal wound dressing |
| Copper impregnated maternity pads | Experimental | Maternity pads impregnated with 3% copper oxide ions, to be used for 14 days after delivery Receives: Other: Copper impregnated maternity pads |
| Normal maternity pads | Placebo comparator | Maternity pads without copper, to be used for 14 days after delivery Receives: Other: Normal maternity pads |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (2)
Length of hospitalisation
Length of in hospital stay following child birth
Measured: 30 days
Pain score
Visual Analog Scale for wound pain
Measured: 7, 14 and 30 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start14 Jan 2016
- Primary completion19 Oct 2017
- Study completion19 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section; InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 774 participants (actual)
Sponsor and investigators
- Lead sponsor
- Croydon Health Services NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mr Abdul H Sultan, Croydon Health Services NHS Trust
- Investigators
- Abdul H Sultan, Principal investigator, Croydon Health Services NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284749
- Sponsor's protocol ID
- 15/07
- Acronym
- ECHO
- Status last verified
- Aug 2018
- First submitted
- 13 Sep 2017
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johnson A, Thakar R, Sultan AH. Obstetric perineal wound infection: is there underreporting? Br J Nurs. 2012 Mar 8-21;21(5):S28, S30, S32-5. doi: 10.12968/bjon.2012.21.Sup5.S28.
PubMed 22489339American College of Obstetrics and Gynecology.. Operative vaginal delivery. Clinical management guidelines for obstetrician-gynecologists. American College of Obstetrics and Gynecology. Int J Gynaecol Obstet. 2001 Jul;74(1):69-76. doi: 10.1016/s0020-7292(01)00434-9. No abstract available.
PubMed 11480404Callwood A, Thomas J. The National Sentinel Caesarean Section Audit. Pract Midwife. 2000 Jun;3(6):34-5. No abstract available.
PubMed 11260996Smaill FM, Grivell RM. Antibiotic prophylaxis versus no prophylaxis for preventing infection after cesarean section. Cochrane Database Syst Rev. 2014 Oct 28;2014(10):CD007482. doi: 10.1002/14651858.CD007482.pub3.
PubMed 25350672Declercq E, Barger M, Cabral HJ, Evans SR, Kotelchuck M, Simon C, Weiss J, Heffner LJ. Maternal outcomes associated with planned primary cesarean births compared with planned vaginal births. Obstet Gynecol. 2007 Mar;109(3):669-77. doi: 10.1097/01.AOG.0000255668.20639.40.
PubMed 17329519Hillan EM. Postoperative morbidity following Caesarean delivery. J Adv Nurs. 1995 Dec;22(6):1035-42. doi: 10.1111/j.1365-2648.1995.tb03102.x.
PubMed 8675855Henderson E, Love EJ. Incidence of hospital-acquired infections associated with caesarean section. J Hosp Infect. 1995 Apr;29(4):245-55. doi: 10.1016/0195-6701(95)90271-6.
PubMed 7658004Ward VP, Charlett A, Fagan J, Crawshaw SC. Enhanced surgical site infection surveillance following caesarean section: experience of a multicentre collaborative post-discharge system. J Hosp Infect. 2008 Oct;70(2):166-73. doi: 10.1016/j.jhin.2008.06.002. Epub 2008 Aug 23.
PubMed 18723248Creech CB, Litzner B, Talbot TR, Schaffner W. Frequency of detection of methicillin-resistant Staphylococcus aureus from rectovaginal swabs in pregnant women. Am J Infect Control. 2010 Feb;38(1):72-4. doi: 10.1016/j.ajic.2009.06.015. Epub 2009 Oct 21.
PubMed 19836855ACOG Practice Bulletin No. 120: Use of prophylactic antibiotics in labor and delivery. Obstet Gynecol. 2011 Jun;117(6):1472-1483. doi: 10.1097/AOG.0b013e3182238c31. No abstract available.
PubMed 21606770Borkow G, Gabbay J. Copper as a biocidal tool. Curr Med Chem. 2005;12(18):2163-75. doi: 10.2174/0929867054637617.
PubMed 16101497Noyce JO, Michels H, Keevil CW. Potential use of copper surfaces to reduce survival of epidemic meticillin-resistant Staphylococcus aureus in the healthcare environment. J Hosp Infect. 2006 Jul;63(3):289-97. doi: 10.1016/j.jhin.2005.12.008. Epub 2006 May 2.
PubMed 16650507O'Gorman J, Humphreys H. Application of copper to prevent and control infection. Where are we now? J Hosp Infect. 2012 Aug;81(4):217-23. doi: 10.1016/j.jhin.2012.05.009. Epub 2012 Jun 26.
PubMed 22738611Borkow G, Gabbay J, Zatcoff RC. Could chronic wounds not heal due to too low local copper levels? Med Hypotheses. 2008;70(3):610-3. doi: 10.1016/j.mehy.2007.06.006. Epub 2007 Aug 6.
PubMed 17689198Sen CK, Khanna S, Venojarvi M, Trikha P, Ellison EC, Hunt TK, Roy S. Copper-induced vascular endothelial growth factor expression and wound healing. Am J Physiol Heart Circ Physiol. 2002 May;282(5):H1821-7. doi: 10.1152/ajpheart.01015.2001.
PubMed 11959648
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial on the Effect of Copper Impregnated Dressings and Maternity Pads on the Healing of Obstetric Wounds and Wound Infection
- ClinicalTrials.gov ID
- NCT03284749
- Acronym / sponsor ID
- ECHO / 15/07
- Keywords
- Copper Oxide, Antibiotic Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 774 participants (actual)
- Lead sponsor
- Croydon Health Services NHS TrustUniversity, hospital or other
- Study start
- 14 Jan 2016 (actual)
- Primary completion
- 19 Oct 2017 (actual)
- Study completion
- 19 Dec 2017 (actual)
- First posted
- 15 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Copper impregnated wound dressing | Experimental | Other: Copper impregnated wound dressingWound dressing impregnated with 3% copper oxide ions, to be applied for 7 days after caesarean section |
| Normal wound dressing | Placebo comparator | Other: Normal wound dressingWound dressing without copper, to be applied for 7 days after caesarean section |
| Copper impregnated maternity pads | Experimental | Other: Copper impregnated maternity padsMaternity pads impregnated with 3% copper oxide ions, to be used for 14 days after delivery |
| Normal maternity pads | Placebo comparator | Other: Normal maternity padsMaternity pads without copper, to be used for 14 days after delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Copper impregnated wound dressingCopper impregnated wound dressing | Other | Copper impregnated wound dressing |
| Normal wound dressingNormal wound dressing | Other | Normal wound dressing |
| Copper impregnated maternity padsCopper impregnated maternity pads | Other | Copper impregnated maternity pads |
| Normal maternity padsNormal maternity pads | Other | Normal maternity pads |
Primary outcome
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
2 secondary outcomes
Length of hospitalisation
Time frame: 30 days
Pain score
Time frame: 7, 14 and 30 days after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Background: PubMed 22489339Johnson A, Thakar R, Sultan AH. Obstetric perineal wound infection: is there underreporting? Br J Nurs. 2012 Mar 8-21;21(5):S28, S30, S32-5. doi: 10.12968/bjon.2012.21.Sup5.S28.
- Background: PubMed 11480404American College of Obstetrics and Gynecology.. Operative vaginal delivery. Clinical management guidelines for obstetrician-gynecologists. American College of Obstetrics and Gynecology. Int J Gynaecol Obstet. 2001 Jul;74(1):69-76. doi: 10.1016/s0020-7292(01)00434-9. No abstract available.
- Background: PubMed 11260996Callwood A, Thomas J. The National Sentinel Caesarean Section Audit. Pract Midwife. 2000 Jun;3(6):34-5. No abstract available.
- Background: PubMed 25350672Smaill FM, Grivell RM. Antibiotic prophylaxis versus no prophylaxis for preventing infection after cesarean section. Cochrane Database Syst Rev. 2014 Oct 28;2014(10):CD007482. doi: 10.1002/14651858.CD007482.pub3.
- Background: PubMed 17329519Declercq E, Barger M, Cabral HJ, Evans SR, Kotelchuck M, Simon C, Weiss J, Heffner LJ. Maternal outcomes associated with planned primary cesarean births compared with planned vaginal births. Obstet Gynecol. 2007 Mar;109(3):669-77. doi: 10.1097/01.AOG.0000255668.20639.40.
- Background: PubMed 8675855Hillan EM. Postoperative morbidity following Caesarean delivery. J Adv Nurs. 1995 Dec;22(6):1035-42. doi: 10.1111/j.1365-2648.1995.tb03102.x.
- Background: PubMed 7658004Henderson E, Love EJ. Incidence of hospital-acquired infections associated with caesarean section. J Hosp Infect. 1995 Apr;29(4):245-55. doi: 10.1016/0195-6701(95)90271-6.
- Background: PubMed 18723248Ward VP, Charlett A, Fagan J, Crawshaw SC. Enhanced surgical site infection surveillance following caesarean section: experience of a multicentre collaborative post-discharge system. J Hosp Infect. 2008 Oct;70(2):166-73. doi: 10.1016/j.jhin.2008.06.002. Epub 2008 Aug 23.
- Background: PubMed 19836855Creech CB, Litzner B, Talbot TR, Schaffner W. Frequency of detection of methicillin-resistant Staphylococcus aureus from rectovaginal swabs in pregnant women. Am J Infect Control. 2010 Feb;38(1):72-4. doi: 10.1016/j.ajic.2009.06.015. Epub 2009 Oct 21.
- Background: PubMed 21606770ACOG Practice Bulletin No. 120: Use of prophylactic antibiotics in labor and delivery. Obstet Gynecol. 2011 Jun;117(6):1472-1483. doi: 10.1097/AOG.0b013e3182238c31. No abstract available.
- Background: PubMed 16101497Borkow G, Gabbay J. Copper as a biocidal tool. Curr Med Chem. 2005;12(18):2163-75. doi: 10.2174/0929867054637617.
- Background: PubMed 16650507Noyce JO, Michels H, Keevil CW. Potential use of copper surfaces to reduce survival of epidemic meticillin-resistant Staphylococcus aureus in the healthcare environment. J Hosp Infect. 2006 Jul;63(3):289-97. doi: 10.1016/j.jhin.2005.12.008. Epub 2006 May 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdul H Sultan principal investigator
Croydon Health Services NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Copper impregnated wound dressing, Normal wound dressing and Copper impregnated maternity pads in people with Cesarean Section; Infection and Perineal Infection, run by Croydon Health Services NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Discharge Questionnaire (PDQ) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03284749, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.