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Effect of Copper on the Healing of Obstetric Wounds

NCT03284749 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 774

Last updated 2018-08-03

No results posted yet for this study

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

Interventions

OTHER

Copper impregnated wound dressing

Copper impregnated wound dressing

OTHER

Normal wound dressing

Normal wound dressing

OTHER

Copper impregnated maternity pads

Copper impregnated maternity pads

OTHER

Normal maternity pads

Normal maternity pads

Sponsors & Collaborators

  • Croydon Health Services NHS Trust

    lead OTHER

Principal Investigators

  • Abdul H Sultan · Croydon Health Services NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-14
Primary Completion
2017-10-19
Completion
2017-12-19

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03284749 on ClinicalTrials.gov