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

ISRCTN	ISRCTN36051617
DOI	https://doi.org/10.1186/ISRCTN36051617
Protocol serial number	2003-263 CMO
Sponsor	Radboud University Nijmegen Medical Centre (Netherlands)
Funder	Radboud University Nijmegen Medical Centre (Netherlands)

Submission date: 31/05/2009
Registration date: 24/07/2009
Last edited: 24/07/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Erik de Laat
Scientific

Radboud University Nijmegen Medical Centre
926 Plastic Surgery
PO Box 9101
Nijmegen
6500 HB
Netherlands

Phone	+31 (0)6 533 55 278
Email	e.delaat@plchir.umcn.nl

Study information

Primary study design	Interventional
Study design	Prospective stratified randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Faster wound healing with topical negative pressure therapy in difficult to heal wounds: a prospective randomised controlled trial
Study objectives	This study aimed to investigate the effectiveness and safety of topical negative pressure therapy, compared with conventional dressing therapy in patients with difficult to heal wounds of various aetiologies and particularly in spinal cord injury (SCI) patients with pressure ulcers.
Ethics approval(s)	Committee on Research Involving Human Subjects, Arnhem Nijmegen approved on the 24th January 2003 (ref: 2003-263 CMO)
Health condition(s) or problem(s) studied	Difficult to heal wounds of various aetiologies
Intervention	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 afternoon). The fluid connection system was changed at least once a week. Patients randomly assigned to the control group received treatment with a sodium hypochlorite 0.25% solution. This wet-to-moist dressing was changed two to three times a day, depending on the wound debris.
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/03/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	24
Key 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
Key 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
Date of first enrolment	01/03/2003
Date of final enrolment	01/03/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

Radboud University Nijmegen Medical Centre

Nijmegen
6500 HB
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes