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

Does Negative Pressure Wound Therapy (NPWT) increase healing rates in post-operative foot wounds in Hospital in the Home (HITH) patients.

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000885897
Enrollment
10
Registered
2012-08-20
Start date
2012-10-01
Completion date
Unknown
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Ten participants will be recruited from Austin health into this pilot randomised controlled trial to investigate if negative pressure wound therapy increases healing rates in people with post operative foot wounds in the home care setting.

Interventions

Negative Pressure Wound Therapy (NPWT) devices will be from VAC therapy and systems range manufactured by the Kinetics Concepts Inc. (KCI)(San Antonio, TX,USA). The duration of treatment will be determined by nurse treating patient in accordance with current practice and based on clinical assessment of healing. The foot wound will be filled with foam dressing and VAC cycle will set for continuous cycle with a target pressure of 125mmHg. Dressings will be changed every 48-72 hours but no less t

Negative Pressure Wound Therapy (NPWT) devices will be from VAC therapy and systems range manufactured by the Kinetics Concepts Inc. (KCI)(San Antonio, TX,USA). The duration of treatment will be determined by nurse treating patient in accordance with current practice and based on clinical assessment of healing. The foot wound will be filled with foam dressing and VAC cycle will set for continuous cycle with a target pressure of 125mmHg. Dressings will be changed every 48-72 hours but no less than 3 times per week as per manufacturers instructions for up to 8 weeks unless healing occurs sooner.

Sponsors

Department of Health Victoria
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026