CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 774 enrolled
Drug / intervention
Copper impregnated wound dressing +3 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03284749
NCT03284749N/ACompleted

Randomised Controlled Trial on the Effect of Copper Impregnated Dressings and Maternity Pads on the Healing of Obstetric Wounds and Wound Infection

Croydon Health Services NHS Trust·interventional·Posted Sep 15, 2017·Updated Aug 3, 2018

In Brief

A clinical study evaluating Copper impregnated wound dressing, Normal wound dressing, and 2 other interventions for Cesarean Section; Infection and 3 related conditions. Completed, enrolled 774 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 15, 2017
Enrollment StartJan 14, 2016
Primary CompletionOct 19, 2017
Study CompletionDec 19, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.8 years ago

Interventions

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