Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03678636 |
| Other study ID # |
WCL#CT/2018/001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 30, 2018 |
| Est. completion date |
February 29, 2020 |
Study information
| Verified date |
April 2022 |
| Source |
Woundchek Laboratories BV |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
100 chronic wounds asymptomatic for infection that test positive for bacterial protease
activity (BPA) on initial screening (approx 250 wounds in total to be tested) will be
randomized to intervention or control. 50 patients will receive intervention (silver
antimicrobial dressing) in addition to standard care and 50 will receive standard care only
(control). Wound healing at 12 weeks will be compared in addition to costs, patient quality
of life, referrals to secondary care, surgical interventions, rates of infection and
antibiotic use.
Description:
A prospective, open randomized controlled study in the community setting. Study participants
will be selected from chronic wound patients being treated in the community by Pennine Care
NHS Foundation Trust that are not considered to be infected and are not currently being
treated with a topical antiseptic dressing. Patients diagnosed with a chronic wound and
determined to meet the study inclusion criteria can be enrolled after informed consent. Only
one wound is allowed per patient (defined as the 'index wound). If a patient has multiple
wounds, the largest wound will be selected.
Enrolled patients will be tested for BPA using the WOUNDCHEK™ Bacterial Status. Patients with
negative results will take no further part in the study. Patients with positive results, will
be randomized into either the Intervention or the Control arm of the study.
The study aims to enrol 100 patients that test positive for BPA. An expected prevalence of
between 40 and 50 percent BPA positive means that between approximately 200 and 250 patients
will need to be enrolled and screened to reach the target number of 100 BPA positive wounds.
A total of up to 100 patients with a chronic wound that test positive for BPA during
screening will be randomized to receive either a silver antimicrobial dressing appropriate
for the wound exudate level for 2 weeks +/- 3 days, in addition to any other standard care
requirements (e.g. compression) (Intervention arm) or receive standard care only (Control
arm).
The patients will be followed up at 12 weeks post enrolment or within two weeks of wound
closure (whichever is earliest). The Research Nurse will visit the patient to measure the
wound size or determine if the wound has healed and complete the EQ5D-5L questionnaire.
The initial contact, enrolment and initial test visit for both groups, follow-up visit for
both groups, will be conducted by the dedicated Research Nurse. All other patient care will
be delivered by the Clinicians from the Community Service.
Data recorded at week 0 (first patient visit for both Control and Intervention groups);
- Eligibility review
- Informed Consent
- WOUNDCHEKTM Bacterial Status result
• Participants who pass screening (i.e. return a positive BPA result) will be enrolled
into the study:
- Randomisation group (if BPA positive)
- Wound type and location
- Wound size (length, width and depth dimensions in cm, +/- 0.1cm)
- Wound age in months
- Wound condition**
- Current treatment
- EQ5D-5L questionnaire
- Wound condition: Ulcer stage/grade, Tissue Present, Amount and viscosity/colour of
exudate, Odour, Surrounding Skin, Pain at wound site.
Data recorded when the wound has healed or at week 12 post randomisation (whichever is
soonest) for both Control and Intervention groups;
- EQ5D-5L
- Wound size
- Wound condition (as per the PCFT wound assessment form)
- If healed, what date it healed.
- All visits and treatments by community services clinician in previous 12 weeks
- Episodes of wound infection
- Antibiotic prescriptions related to wound infection
- Any GP consultations or A&E visits associated with the wound.
- Any referrals for treatment in secondary care associated with the wound including any
surgical intervention
The study will be expected to last for a year or until completion of the last visit of the
100th patient.
