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van CCT (UK)

van CCT (UK)

Aquacel AG Surgical trial: reducing wound infections after breast cancer surgery

- candidate number24403
- NTR NumberNTR5840
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-mei-2016
- Secondary IDsNL42892.101.12 CCMO/ABR nummer
- Public TitleAquacel AG Surgical trial: reducing wound infections after breast cancer surgery
- Scientific TitleAquacel AG Surgical trial: a randomized controlled trial on wound infections after breast cancer surgery
- hypothesisOne out of eight women will develop breast cancer, the majority of this group receives breast surgery. Each clinic has its own ‘standard’ postoperative wound care. Standard wound dressings can have undesirable side effects, like wound infections and blister formation, for example by changing the dressing on regular base. This study compares Aquacel AG Surgical with standard wound dressing. This occlusive dressing delivers ionic silver when in contact with the wound exudate and has an antibacterial effect, which makes less changing of the dressing needed. In our hospital infection rate after breast cancer surgery is 12-13%, several studies in literature mention 3-15%. Main goal of this study is to determine if the use of Aquacel AG Surgical reduces the occurrence of postoperative wound infections after breast cancer surgery.
- Healt Condition(s) or Problem(s) studiedBreast cancer, Surgery, Wound infection
- Inclusion criteriawomen of 18 years or older
diagnosed with breast cancer,
needing ablative or breast conserving surgery
written informed consent.
- Exclusion criterialocal inflammation or ulceration of the breast;
prior breast surgery in the past 3 months;
use of antibiotics in the past 2 weeks;
neo-adjuvant chemotherapy;
direct reconstruction
known allergy for Aquacel AG Surgical or silver
inability of reading or understanding to give informed consent or fill out questionnaires.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2013
- planned closingdate10-aug-2016
- Target number of participants212
- InterventionsIncluded patients underwent breast surgery; breast ablative therapy or breast conservative therapy. All procedures were performed or supervised by senior surgeons with a case load of more than 50 per year. After surgery, patients got their allocated wound care: standard wound dressing, consisting of a gauze fixed with adhesive tape, or Aquacel Ag Surgical. Standard wound dressing was changed as often as needed, in patients opinion . Aquacel Ag Surgical was kept in place for 7 days, unless saturated by excessive exudate . After the 10th day of surgery, follow up took place at the outpatient clinic by an independent specialized nurse and the surgeon or surgical resident. The wound was inspected on the presence of infection following CDC criteria and patients filled out a questionnaire on patient satisfaction. Re-admissions/operations, extra ER /GP/outpatient clinic visits, the occurrence wound infections and use of antibiotics were scored 30 days after surgery during a phone consult. Patient records were checked for deep infections until the 90th day post-operative.
- Primary outcomePrimary outcome of this study was incidence of post-operative wound infection, following CDC criteria
- Secondary outcomeSecondary outcome measure was patient satisfaction on a 10-point numerical rating scale, presence of 2 'classic' symptoms of infectionsre-admissions/operations, infections and use of antibiotics
- Timepointssee interventions
- Trial web site
- statusinclusion stopped: follow-up
- Sponsor/Initiator Franciscus Gasthuis & Vlietland, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summary
- Main changes (audit trail)Trial registered on website after recruitment is closed-EB
- RECORD26-mei-2016 - 28-jun-2016

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