Contact information
Type
Scientific
Primary contact
Dr Magnus Ågren
ORCID ID
Contact details
Department of Surgery K
Bispebjerg Hospital
University of Copenhagen
Bispebjerg Bakke 23
Copenhagen
DK-2400
Denmark
+45 35316493
magnus.agren@get2net.dk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
ZÅRSTUDIET
Study hypothesis
Locally applied zinc oxide (ZnO) may be beneficial for various types of human wounds. This randomised, double-blind, placebo-controlled multicentre trial compared the effect of topical ZnO with placebo under moist conditions on the healing of excisional wounds following surgical removal of the pilonidal sinus.
Ethics approval
No ethics information required 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
Pilonidal excisional wound
Intervention
Zinc oxide and polyvinylpyrrolidone versus polyvinylpyrrolidone alone
Intervention type
Drug
Phase
Not Specified
Drug names
Topical zinc oxide
Primary outcome measure
Time to wound closure in days, defined by complete coverage of the
wound with visible epithelium.
Secondary outcome measures
Secondary outcomes were:
1. Postoperative antibiotic treatment
2. Re-operations
3. Pain intensity
4. Adverse events
Tertiary outcomes were:
1. Serum-zinc levels
2. Sick leave
Overall trial start date
01/02/2002
Overall trial end date
01/05/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients, 18 years or older, with a first-episode of pilonidal abscess requiring surgery are included after giving their written informed consent.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
75
Participant exclusion criteria
Previous pilonidal surgery, hypersensitivity to zinc, dementia, insufficiency in Danish, pregnancy or lactation.
Recruitment start date
01/02/2002
Recruitment end date
01/05/2004
Locations
Countries of recruitment
Denmark
Trial participating centre
Department of Surgery K
Copenhagen
DK-2400
Denmark
Sponsor information
Organisation
Bispebjerg Hospital (Denmark)
Sponsor details
Department of Surgery K
Bispebjerg Hospital
University of Copenhagen
Bispebjerg Bakke 23
Copenhagen
DK-2400
Denmark
+45 35316493
magnus.agren@get2net.dk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Apotekerfonden 1991, Abigo Medical AB
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
Basic results (scientific)
Publication list
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17014663
Publication citations
-
Results
Agren MS, Ostenfeld U, Kallehave F, Gong Y, Raffn K, Crawford ME, Kiss K, Friis-Møller A, Gluud C, Jorgensen LN, A randomized, double-blind, placebo-controlled multicenter trial evaluating topical zinc oxide for acute open wounds following pilonidal disease excision., Wound Repair Regen, 14, 5, 526-535, doi: 10.1111/j.1743-6109.2006.00159.x.