Effect of Copper on the Healing of Obstetric Wounds

NCT03284749 | Completed

• 1 other identifier: 15/07
• Study Type: interventional
• Target: 774
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section; Infection; Perineal Infection; Wound Infection; Surgical Site Infection

Keywords

Copper Oxide; Antibiotic Resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Length of hospitalisation

  30 days

• Pain score

  7, 14 and 30 days after delivery

Study Arms (4)

Copper impregnated wound dressing

EXPERIMENTAL

Wound dressing impregnated with 3% copper oxide ions, to be applied for 7 days after caesarean section

Other: Copper impregnated wound dressing

Normal wound dressing

PLACEBO COMPARATOR

Wound dressing without copper, to be applied for 7 days after caesarean section

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

Other: Copper impregnated maternity pads

Normal maternity pads

PLACEBO COMPARATOR

Maternity pads without copper, to be used for 14 days after delivery

Other: Normal maternity pads

Interventions

Copper impregnated wound dressing OTHER

Copper impregnated wound dressing

Copper impregnated wound dressing

Normal wound dressing OTHER

Normal wound dressing

Normal wound dressing

Copper impregnated maternity pads OTHER

Copper impregnated maternity pads

Copper impregnated maternity pads

Normal maternity pads OTHER

Normal maternity pads

Normal maternity pads

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Croydon Health Services NHS Trust: lead

Study Sites (1)

Croydon Health Services NHS Trust

Croydon, CR7 7YE, United Kingdom

Location

Related Publications (17)

• 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.

  PMID: 22489339 BACKGROUND

• American 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.

  PMID: 11480404 BACKGROUND

• Callwood A, Thomas J. The National Sentinel Caesarean Section Audit. Pract Midwife. 2000 Jun;3(6):34-5. No abstract available.

  PMID: 11260996 BACKGROUND

• Smaill 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.

  PMID: 25350672 BACKGROUND

• Declercq 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.

  PMID: 17329519 BACKGROUND

• Hillan EM. Postoperative morbidity following Caesarean delivery. J Adv Nurs. 1995 Dec;22(6):1035-42. doi: 10.1111/j.1365-2648.1995.tb03102.x.

  PMID: 8675855 BACKGROUND

• Henderson 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.

  PMID: 7658004 BACKGROUND

• Ward 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.

  PMID: 18723248 BACKGROUND

• Creech 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.

  PMID: 19836855 BACKGROUND

• ACOG 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.

  PMID: 21606770 BACKGROUND

• Borkow G, Gabbay J. Copper as a biocidal tool. Curr Med Chem. 2005;12(18):2163-75. doi: 10.2174/0929867054637617.

  PMID: 16101497 BACKGROUND

• Noyce 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.

  PMID: 16650507 BACKGROUND

• O'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.

  PMID: 22738611 BACKGROUND

• Borkow 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.

  PMID: 17689198 BACKGROUND

• Sen 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.

  PMID: 11959648 BACKGROUND

• Uauy R, Olivares M, Gonzalez M. Essentiality of copper in humans. Am J Clin Nutr. 1998 May;67(5 Suppl):952S-959S. doi: 10.1093/ajcn/67.5.952S.

  PMID: 9587135 BACKGROUND

• Hostynek JJ, Dreher F, Maibach HI. Human skin penetration of a copper tripeptide in vitro as a function of skin layer. Inflamm Res. 2011 Jan;60(1):79-86. doi: 10.1007/s00011-010-0238-9. Epub 2010 Aug 20.

  PMID: 20721598 BACKGROUND

MeSH Terms

Conditions

Infections; Wound Infection; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Abdul H Sultan

  Croydon Health Services NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Obstetrician and Gynaecologist

Model Details: 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.

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 15, 2017
• Study Start: January 14, 2016
• Primary Completion: October 19, 2017
• Study Completion: December 19, 2017
• Last Updated: August 3, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)