Clinical Trial Results:
Reduction of postoperative wound infections by antiseptica
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Summary
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EudraCT number |
2014-001551-22 |
Trial protocol |
DE |
Global end of trial date |
26 Jun 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Feb 2020
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First version publication date |
09 Feb 2020
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Other versions |
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Summary report(s) |
Summary_RECIPE |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
RECIPE2014
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Charite Universitaetsmedizin berlin
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Sponsor organisation address |
Hindenburgdamm 30, Berlin, Germany, 12200
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Public contact |
study coordinator, Charité Universitätsmedizin, 0049 03084452948, marja.leonhardt@charite.de
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Scientific contact |
study coordinator, Charité Universitätsmedizin, 0049 03084452948, marja.leonhardt@charite.de
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
10 Apr 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
26 Jun 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
26 Jun 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Randomised controlled trial testing if the antiseptic subcutaneous applied solution SERASEPT is capable of reducing postoperative wound infections compared to NaCl-Solution in visceral surgery
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Protection of trial subjects |
All patients were interviewed 30 days postoperatively and asked for pain and satisfaction with the cosmetic result. In case of questions or need for clinical examination, all patients were advised to come to our emergency department.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Oct 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 456
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Worldwide total number of subjects |
456
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EEA total number of subjects |
456
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
270
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From 65 to 84 years |
182
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85 years and over |
4
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Recruitment
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Recruitment details |
Patients were enrolled by one of the surgeons involved in the trial either on surgical ward or in preoperative outpatient clinic at the Charite hospital Campus Benjamin Franklin berlin between 02/15 and 05/18. | |||||||||
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Pre-assignment
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Screening details |
Patients > 18, capable to give informed consent and undergoing elective open or laparoscopic-assisted gastrointestinal surgery with mini-laparotomy were eligible to participate. Patients with emergency operations, laparoscopic surgery, surgery of the abdominal wall, vascular surgery or allergy to one of the irrigation solutions were excluded. | |||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | |||||||||
Roles blinded |
Subject | |||||||||
Blinding implementation details |
only patients were blinded. there was no blinding of the operating surgeon as the
application time differed between saline and polyhexanide.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Control group | |||||||||
Arm description |
subcutaneous irrigation with 250mL 0.9% saline | |||||||||
Arm type |
Treatment as usual | |||||||||
Investigational medicinal product name |
Na CL
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cutaneous solution
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Routes of administration |
Cutaneous use
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Dosage and administration details |
subcutaneous irrigation with 250mL 0.9% saline
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Arm title
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Experimental group | |||||||||
Arm description |
250mL antiseptic 0.04% polyhexanide solution | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Serasept 2, Serag Wiessner
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Investigational medicinal product code |
57862.00.00
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Other name |
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Pharmaceutical forms |
Cutaneous solution
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Routes of administration |
Cutaneous use
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Dosage and administration details |
After the closure of fascia, subcutaneous
irrigation with 250mL antiseptic 0.04% polyhexanide solution
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| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Control group: 228 assigned wound irrigation with 0.9% saline, but due to 3x consent, withdrawn, 5x no wound irrigation: 3x laparoscopic surgery, 1x no skin closure, 1x transanal surgery, 10x wrong irrigation, 2x refusal of surgery only 208 had wound irrigation with 0.9% saline. Experimental gruoup: 228 assigned wound irrigation with 0.04% polyhexanide, but due to 8x consent withdrawn, 1x no wound irrigation: ostomy in incision, 16x wrong irrigation, 1x double randomization 1x surgey canceld |
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End points reporting groups
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Reporting group title |
Control group
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Reporting group description |
subcutaneous irrigation with 250mL 0.9% saline | ||
Reporting group title |
Experimental group
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Reporting group description |
250mL antiseptic 0.04% polyhexanide solution | ||
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End point title |
incidence of any SSI | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
30 days after surgery
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Statistical analysis title |
cross tabulation and the chi-squared test. | |||||||||
Statistical analysis description |
The biometric outcome assessor was blinded to the allocation
for the analysis of the trial. The primary hypothesis was analyzed
with cross tabulation and the chi-squared test. We analyzed the
primary endpoint—the rate of SSI within 30 days postoperatively—
with the per protocol population and confirmed the results
with the intention to treat population. For categorical outcomes such
as our secondary parameters, statistical group comparisons were
performed using chi-square test. Because of
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Comparison groups |
Control group v Experimental group
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Number of subjects included in analysis |
393
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Chi-squared | |||||||||
Confidence interval |
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End point title |
Rate of colonization of the abdominal wall with bacteria in the intraoperative swab after irrigation. | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
30 days after surgery
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| No statistical analyses for this end point | ||||||||||
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End point title |
Length of hospital stay in days | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Up to one month after recruitment
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| No statistical analyses for this end point | ||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
From recruitment of the first patient to the end of follow-up of the last inroled patient (02/15-06/18)
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||
Dictionary version |
5.0
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: We have not recordet any non-serious events in the trial |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/31599810 |
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