Classical versus Modern Local Wound Care in Surgical Patients: A Randomized Controlled Trial

ISRCTN	ISRCTN56264738
DOI	https://doi.org/10.1186/ISRCTN56264738
Secondary identifying numbers	IBC15010, NL492, NTR534

Submission date: 04/01/2006
Registration date: 05/01/2006
Last edited: 11/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M.J. Lubbers
Scientific

Academic Medical Center (AMC), Department of Surgery
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 5662470
Email	m.j.lubbers@amc.uva.nl

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Classical versus Modern Local Wound Care in Surgical Patients: A Randomized Controlled Trial
Study acronym	MOKUM trial
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Wound Care
Intervention	Occlusive wound dressing materials versus gauze dressings
Intervention type	Other
Primary outcome measure	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 study start date	23/04/2004
Completion date	14/09/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	285
Total final enrolment	285
Key inclusion criteria	1. Adult patients admitted to the departments of surgery with open wounds requiring local wound care 2. Written informed consent
Key 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
Date of first enrolment	23/04/2004
Date of final enrolment	14/09/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Center (AMC), Department of Surgery

Amsterdam
1105 AZ
Netherlands

Sponsor information

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

Postbus 22660
Amsterdam
1105 AZ
Netherlands

"ROR"	https://ror.org/03t4gr691

Funders

Funder type

Industry

M, Smith&Nephew, Johnson & Johnson, Convatec

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2008	11/01/2021	Yes	No

Editorial Notes

11/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.