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
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 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(s) | No ethics information required at time of registration. |
| Condition | 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 |
| Overall study end date | 01/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 75 |
| 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 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
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 |
