Contact information
Type
Scientific
Primary contact
Dr M.J. Lubbers
ORCID ID
Contact details
Academic Medical Center (AMC)
Department of Surgery
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 5662470
m.j.lubbers@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
IBC15010
Study information
Scientific title
Acronym
MOKUM trial
Study hypothesis
Occlusive, non-gauze based wound dressings are more effective (as to time to complete wound healing, pain during dressing changes, and costs) than non-occlusive, gauze-based dressings for local wound care.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Wound Care
Intervention
Occlusive wound dressing materials versus gauze dressings
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Time to complete wound healing
Secondary outcome measures
1. Pain during dressing changes
2. Material and nursing costs of dressing changes
3. Duration of hospitalisation
4. Adverse effects of dressings
Overall trial start date
23/04/2004
Overall trial end date
14/09/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adult patients admitted to the departments of surgery with open wounds requiring local wound care
2. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
285
Participant exclusion criteria
1. Burn and malignant wounds
2. Surgically closed wounds
3. Wounds treated with vacuum assisted closure (VAC) devices
4. Ostomies or drain openings
5. Pin holes from external fixation materials
6. Patients receiving chemotherapy or local irradiation therapy
7. Patients with a life expectancy <6 months
Recruitment start date
23/04/2004
Recruitment end date
14/09/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center (AMC), Department of Surgery
Amsterdam
1105 AZ
Netherlands
Funders
Funder type
Industry
Funder name
M, Smith&Nephew, Johnson & Johnson, Convatec
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