WOUNDCHEK Bacterial Status Benefits Evaluation

Chronic Wounds Clinical Trial

Official title: Clinical and Economic Effectiveness of Testing Chronic Wounds for BPA (Bacterial Protease Activity) Using WOUNDCHEK Bacterial Status: A Pragmatic Randomised Clinical Trial

Status Completed

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Chronic Wounds

• NCT number: NCT03678636
• Study type: Interventional
• Source: Woundchek Laboratories BV
• Status: Completed
• Phase: N/A
• Start date: July 30, 2018
• Completion date: February 29, 2020