Faster wound healing with topical negative pressure therapy in difficult to heal wounds

Faster wound healing with topical negative pressure therapy in difficult to heal wounds: a prospective randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN36051617

Enrollment

Registered

2009-07-24

Start date

2003-03-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Difficult to heal wounds of various aetiologies Injury, Occupational Diseases, Poisoning Open wounds involving multiple body regions

Interventions

Patients randomly assigned to topical negative pressure therapy received a treatment with the VAC-system™ (Vacuum-Assisted Closure

KCI USA, San Antonio, TX, USA). According to manufacturer's instructions for use, the foam dressings and the TRAC Pad® were changed three times a week (Monday morning, Wednesday and Friday in the afte

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged greater than or equal to 18 years, either sex 2. Difficult to heal surgical wounds (i.e. dehisced abdominal wounds, complex pilonidal sinus, infected wounds and pressure ulcers) 3. Paraplegic and tetraplegic patients with pressure ulcers grade IV according to the European Pressure Ulcer Advisory Panel grading system

Exclusion criteria

Exclusion criteria: 1. Untreated osteomyelitis 2. A life expectation less than one year 3. Radiation or chemical exposure 4. Pregnant or lactating females 5. Not able to comply to one of the interventions 6. Treated with one of the study treatments in the past 30 days

Design outcomes

Primary

Measure	Time frame
Time to 50% wound volume reduction, with a maximum follow-up time of six weeks. This point was determined by measuring the difference between the weekly measured wound volume and the initial wound volume before treatment.	—

Secondary

Measure	Time frame
1. Wound healing failure rates, defined as any deterioration of the wound that necessitated changing the treatment protocol to which patient was assigned 2. Any adverse event, defined as any unfavourable and unintended diagnosis, symptom, sign, syndrome, or disease that either arose during the study, or seemed to deteriorate, if present at baseline Wound healing failure and adverse events were only diagnosed as such after confirmation by an independent physician.	—

Measure

Time frame

1. Wound healing failure rates, defined as any deterioration of the wound that necessitated changing the treatment protocol to which patient was assigned 2. Any adverse event, defined as any unfavourable and unintended diagnosis, symptom, sign, syndrome, or disease that either arose during the study, or seemed to deteriorate, if present at baseline Wound healing failure and adverse events were only diagnosed as such after confirmation by an independent physician.

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Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026