The main objective of this study is to compare the efficacy, in skin antisepsis in forefoot surgery. Therefore we will compare povidine-jodine with chloride-hexidine both soluted in 70% alcohol.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary end point of this study is the number of positive swab cultures. If
positive there ill be a qualitative and quantitative analysis.
Secondary outcome
The secondary outcome of the study is the number of post-operative wound
infections till 6 weeks postoperative and allergic event against the skin
preparative.
Background summary
Feet are a part of the human body which are usualy often cantominated wih
bacterial species.
In the past several publications have compared chloride-hexidine Alcohol with
povidone-iodine. In these studies chloride-hexidine seems in favour for skin
antisepsis.
So far there hasn*t been a research project which compares chloride-hexidine
Alcohol versus povidone-iodine Alcohol.
Our purpose is to evaluate the efficacy of chloride-hexidine soluted in 70%
alcohol and povidine-iodine sluted in 70% alcohol in skinpreparation in
forefoot surgery
Study objective
The main objective of this study is to compare the efficacy, in skin antisepsis
in forefoot surgery. Therefore we will compare povidine-jodine with
chloride-hexidine both soluted in 70% alcohol.
Study design
All patient at our outpatient clinic fulfillling the inclusion criteria will be
informed about the study.
They will be informed again and asked to participate during a second visit. In
case of participation the patient will sign the informed consent.
Prior to skin preparation swaps will be taken from the webspace of the first en
second toe and from the place where we will incise the skin.
After skin preparation and after wound closure the same procedure (skinswaps
from wapsapce and incision place) will be repeted.
No surgical drapes will be used.
All swabs will have a quantative and qualitative analysis.
Visits will be done 1 day, 2 weeks and 6 weeks post-operative.
Woundinfections will be counted according to the PREZIES criteria.
Intervention
n.v.t.
Study burden and risks
There are no extra visits than for pateints undergoing the same surgery but not
participating in this study.
There are no other risk than related to the operation.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
informed consent
age> 18
indication for hallux valgus correction or arthrodesis of the MTP 1 joint
Exclusion criteria
active infection
allergic for jodine and/or chlorhexidine
skindefect
bloodcoagulopathy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT:identificatienummervolgt |
| CCMO | NL39133.100.12 |