Condition category
Skin and Connective Tissue Diseases
Date applied
04/01/2006
Date assigned
05/01/2006
Last edited
20/02/2006
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 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

Sponsor information

Organisation

Academic Medical Center (AMC), Department of Surgery (The Netherlands)

Sponsor details

Postbus 22660
Amsterdam
1105 AZ
Netherlands

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes