Clinical Trials Register

Summary
EudraCT Number:	2017-000152-26
Sponsor's Protocol Code Number:	IOW-1755-REI-0540-I
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-04-26
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2017-000152-26

A.3

Full title of the trial

Intraoperative wound irrigation to prevent surgical site infection after
laparotomy

Intraoperative Wundspülung zur Prävention von postoperativen
Wundinfektionen nach Laparatomie

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Intraoperative wound irrigation to prevent surgical site infection after
laparotomy

Intraoperative Wundspülung zur Prävention von postoperativen
Wundinfektionen nach Laparatomie

A.3.2

Name or abbreviated title of the trial where available

IOWSI

A.4.1

Sponsor's protocol code number

IOW-1755-REI-0540-I

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Technische Universität München Fakultät für Medizin
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Deutsche Forschungsgesellschaft (DFG) grant number: MU 3928/1-1
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Technische Universität München Klinikum rechts der Isar
B.5.2	Functional name of contact point	Klinik und Poliklinik für Chirurgie
B.5.3	Address:
B.5.3.1	Street Address	Ismaningerstr. 22
B.5.3.2	Town/ city	München
B.5.3.3	Post code	81675
B.5.3.4	Country	Germany
B.5.4	Telephone number	0049(0)8941405019
B.5.5	Fax number	0049(0)8941406322
B.5.6	E-mail	daniel.reim@tum.de

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Irrigation solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Other use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	POLIHEXANIDE
D.3.9.1	CAS number	32289-58-0
D.3.9.4	EV Substance Code	SUB09970MIG
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1000
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Irrigation solution
D.8.4	Route of administration of the placebo	Other use (Noncurrent)

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

To investigate whether the use of intraoperative, epifascial wound
irrigation with polyhexanide (PHX) solution can reduce surgical site
infections (SSI) after laparotomy for visceral surgery compared to saline
irrigation or no irrigation.

Untersuchung ob die intraoperative epifasziale Wundspülung des
Subkutangewebes mit Polyhexanid (PHX) Lösung im Vergleich zu
Wundspülung mit Kochsalzlösung oder keiner Wundspülung, die Rate an postoperativen Wundinfektionen nach abdominal chirurgischen
Eingriffen mittels Laparotomie vermindern kann.

E.1.1.1

Medical condition in easily understood language

Wound irrigation for the prevention of postoperative wound infections.

Wundspülung zur Vorbeugung von postoperativen Wundinfekten.

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To investigate whether the use of intraoperative, epifascial wound irrigation with polyhexanide (PHX) solution can reduce surgical site infections after laparotomy for visceral surgery compared to saline irrigation or no irrigation.

Untersuchung ob die intraoperative epifasziale Wundspülung des Subkutangewebes mit Polyhexanid (PHX) Lösung im Vergleich zu Wundspülung mit Kochsalzlösung oder keiner Wundspülung, die Rate an postoperativen Wundinfektionen nach abdominal chirurgischen Eingriffen mittels Laparotomie vermindern kann.

E.2.2

Secondary objectives of the trial

not applicable

nicht zutreffend

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Clean-contaminated, contaminated or dirty surgery according to Centre for Disease Control (CDC) classification;
• Abdominal surgery by midline or transverse laparotomy; elective and emergency procedures;
• Age ≥ 18 years;
• American Society of Anesthesiologists (ASA) score ≤ 3;
• Ability to understand the nature and extent of the trial and to give written informed consent;

• Sauber-kontaminierte, kontaminierte oder septische, abdominal-chirurgische Eingriffe laut Center for Disease Control (CDC)-Klassifikation
• Abdominal-chirurgische Eingriffe mittels Längs- oder Querlaparotomie, sowohl elektiv als auch notfallmäßig;
• Alter ≥ 18 Jahre;
• American Society of Anesthesiologists (ASA) Score ≤ 3;
• Fähigkeit die Patientenaufklärung zu verstehen und schriftlich einzuwilligen

E.4

Principal exclusion criteria

• Pregnancy or breast feeding;
• Known hypersensitivity/allergy to PHX;
• Inability to understand/give informed consent;
• ASA >3;
• Critical medical condition of emergency patients, precluding informed consent or sufficient time to reflect on the decision to participate in the trial
• Inability to attend follow-up visits;
• Clean procedures according to the CDC classification or surgery without opening of the abdominal cavity;
• Laparoscopic surgery;
• Revision-surgery (previous abdominal surgery within the last 30 days);
• Planned re-laparotomy within 30 days;
• Severe immunosuppression;
• Concurrent abdominal wall infections;
• Pre-operative antibiotic therapy (within 5 days prior to surgery) except for emergencies due to septic peritonitis
• Participation in another clinical trial that interferes with the primary or secondary outcomes of this trial

• Schwangerschaft oder Stillzeit;
• Bekannte Überempfindlichkeit / Allergie auf PHX;
• Unfähigkeit die Patientenaufklärung zu verstehen oder schriftlich einzuwilligen;
• ASA >3;
• Unfähigkeit die Studienvisiten wahrzunehmen;
• Saubere Eingriffe analog CDC-Klassifikation, oder chirurgischer Eingriff ohne Eröffnung der Abdominalhöhle
• Laparoskopische Eingriffe
• Revisionseingriffe (vorheriger Eingriff innerhalb der letzten 30 Tage)
• Geplante Re-Laparotomie innerhalb von 30 Tagen
• Schwere Immunsuppression
• Simultane Bauchwand Infektionen
• Prä-operative antibiotische Therapie (innerhalb von 5 Tagen vor dem geplanten Eingriff) mit Ausnahme der Notfalltherapie bei septischer Peritonitis

E.5 End points

E.5.1

Primary end point(s)

SSI according to CDC criteria within 30 days postoperatively

Rate an postoperativen Wundinfektionen innerhalb von 30 Tagen analog der CDC-Definition

E.5.1.1

Timepoint(s) of evaluation of this end point

30 days

30 Tage

E.5.2

Secondary end point(s)

• Non-infectious wound complications (e.g. seroma, hematoma, delayed healing) within 30 days postoperatively
• Duration of hospital stay
• Mortality and morbidity within 30 days postoperatively
• Incidence of reoperation within 30 days postoperatively
• Incidence of AE/SAE within 30 days postoperatively

• Nicht-infektiöse Wundkomplikationen (z.B. Serom, Hämatom, verzögerte Wundheilung) innerhalb 30 Tage postoperativ
• Dauer des stationären Krankenhausaufenthaltes
• Mortalität und Morbidität innerhalb von 30 Tagen postoperativ
• Re-Operationsrate innerhalb von 30 Tagen postoperativ
• AE/SAE Inzidenzrate innerhalb 30 Tage postoperativ

E.5.2.1

Timepoint(s) of evaluation of this end point

30 days

30 Tage

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

3 Gruppen

3 groups

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

4/2022 LVLS

4/2022 letzte Visite letzter Patient

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

300

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

240

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-04-26.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

Yes

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

680

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

After the end of the study patients regardless of whether the study end
according to the protocol or early / non-terminated according to
protocol, the patient get continued Treatment by Physician or clinic standard therapie.

Nach Ende der Studie können Patienten unabhängig davon, ob die
Studie protokollgemäß oder vorzeitig/nicht-protokollgemäß beendet
wurde, bekommen die Patienten eine Weiterbehandlung beim Hausarzt oder die Standard Therapie der jeweiligen Klinik in der der Patient liegt.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-06-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-06-27

P. End of Trial
P.	End of Trial Status	Completed

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