Topical zinc oxide for open pilonidal sinus wounds: a randomised, double-blind, placebo-controlled multicentre trial

ISRCTN	ISRCTN35311675
DOI	https://doi.org/10.1186/ISRCTN35311675
Protocol serial number	N/A
Sponsor	Bispebjerg Hospital (Denmark)
Funder	Apotekerfonden 1991, Abigo Medical AB

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Magnus Ågren
Scientific

Department of Surgery K
Bispebjerg Hospital
University of Copenhagen
Bispebjerg Bakke 23
Copenhagen
DK-2400
Denmark

Phone	+45 35316493
Email	magnus.agren@get2net.dk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	ZÅRSTUDIET
Study objectives	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(s)	No ethics information required at time of registration.
Health condition(s) or problem(s) studied	Pilonidal excisional wound
Intervention	Zinc oxide and polyvinylpyrrolidone versus polyvinylpyrrolidone alone
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Topical zinc oxide
Primary outcome measure(s)	Time to wound closure in days, defined by complete coverage of the wound with visible epithelium.
Key secondary outcome measure(s)	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
Completion date	01/05/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	75
Key inclusion criteria	Patients, 18 years or older, with a first-episode of pilonidal abscess requiring surgery are included after giving their written informed consent.
Key exclusion criteria	Previous pilonidal surgery, hypersensitivity to zinc, dementia, insufficiency in Danish, pregnancy or lactation.
Date of first enrolment	01/02/2002
Date of final enrolment	01/05/2004

Department of Surgery K

Copenhagen
DK-2400
Denmark

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2006		Yes	No