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 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/09/2004
- Registration date
- 29/09/2004
- Last edited
- 25/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Magnus Ågren
Scientific
Scientific
Department of Surgery K
Bispebjerg Hospital
University of Copenhagen
Bispebjerg Bakke 23
Copenhagen
DK-2400
Denmark
| Phone | +45 35316493 |
|---|---|
| magnus.agren@get2net.dk |
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 | |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/02/2002 |
| Completion date | 01/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Department of Surgery K
Copenhagen
DK-2400
Denmark
DK-2400
Denmark
Sponsor information
Bispebjerg Hospital (Denmark)
Hospital/treatment centre
Hospital/treatment centre
Department of Surgery K
Bispebjerg Hospital
University of Copenhagen
Bispebjerg Bakke 23
Copenhagen
DK-2400
Denmark
| Phone | +45 35316493 |
|---|---|
| magnus.agren@get2net.dk | |
"ROR" |
https://ror.org/00td68a17 |
Funders
Funder type
Industry
Apotekerfonden 1991, Abigo Medical AB
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 | 01/09/2006 | Yes | No |
