A pilot randomised controlled trial of Negative Pressure Wound Therapy (NPWT) in Hospital in the Home (HITH) to treat post-operative foot wounds

Not Applicable

Withdrawn

• Conditions: Post operative foot wounds; Diabetes; Other - Research that is not of generic health relevance and not applicable to specific health categories listed above

• Registration Number: ACTRN12612000885897
• Lead Sponsor: Department of Health Victoria

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-20
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Male and female participants aged over 18 years
-Post-operative foot amputation to the trans metatarsal level of foot
greater than or equal to 5cm2 to less than or equal to 20 cm2 measured by digital planimetry
-Adequate peripheral perfusion (Ankle Brachial indices greater than 0.7mm Hg,)
-Fit Austin HITH discharge criteria

Exclusion Criteria

Patients diagnosed with malignant foot wounds, unexplored fistula, exposed blood vessels, necrotic tissue with eschar, unstable coagulation therapy, untreated osteomyelitis and/or wound infection, malnutrition and /or low serum albumin. (NPWT guidelines)
-Patients who cannot tolerate NPWT as inpatient prior to discharge to HITH
-Patients with cognitive impairment/dementia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be proportion of wounds healed using clinical assessment and Visitrak wound measurement system[within 8 weeks compared for the two groups.<br>measured with clinical assesments]

Secondary Outcome Measures

Name	Time	Method
time to healing[Wound tracings will be calculated with Visitrak wound management system at baseline and weekly for 8 weeks or until healed (whichever comes first).];frequency of treatment,[measured with clinical assesments and nursing treatment visits weekly for 8 weeks or until healed (whichever comes first).];wound recurrence[1 month post healing<br>measured with clinical assesments and participant self report of wound recurrence];resources used/costs[measured weekly for 8 weeks with participant self report and medical records data];recruitment rates[researchers will document number of participants screened and recruited weekly for 8 weeks];Pain and health -related quality of life[Overall pain: Participant's global assessment of overall pain and activity-related pain will be measured with a standardized 0[no pain] -100 [maximum pain] numerical scale at each visit. <br>Health-related quality of life: will be meausred at Baseline and 8 weeks)]