Condition category
Surgery
Date applied
20/09/2004
Date assigned
29/09/2004
Last edited
25/09/2009
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 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 measures

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

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

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17014663

Publication citations

  1. 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.

Additional files

Editorial Notes