Condition category
Injury, Occupational Diseases, Poisoning
Date applied
31/05/2009
Date assigned
24/07/2009
Last edited
24/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Erik de Laat

ORCID ID

Contact details

Radboud University Nijmegen Medical Centre
926 Plastic Surgery
PO Box 9101
Nijmegen
6500 HB
Netherlands
+31 (0)6 533 55 278
e.delaat@plchir.umcn.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2003-263 CMO

Study information

Scientific title

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

Acronym

Study hypothesis

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

Committee on Research Involving Human Subjects, Arnhem Nijmegen approved on the 24th January 2003 (ref: 2003-263 CMO)

Study design

Prospective stratified randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 outcome measures

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.

Overall trial start date

01/03/2003

Overall trial end date

01/03/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24

Participant 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

Recruitment start date

01/03/2003

Recruitment end date

01/03/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Radboud University Nijmegen Medical Centre
Nijmegen
6500 HB
Netherlands

Sponsor information

Organisation

Radboud University Nijmegen Medical Centre (Netherlands)

Sponsor details

690 Department of Surgery
PO Box 9101
Nijmegen
6500 HB
Netherlands
+31 (0)2 436 16 421
H.vanGoor@CHIR.umcn.nl

Sponsor type

Hospital/treatment centre

Website

http://www.umcn.nl/scientist/afdelingen/heelkunde?actieve_tab=scientist

Funders

Funder type

Hospital/treatment centre

Funder name

Radboud University Nijmegen Medical Centre (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes