Reduction of wound infections after an operation by antiseptica?

Reduction of postoperative wound infections by antiseptica - RECIPE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001551-22-DE

Enrollment

456

Registered

2014-06-18

Start date

2014-12-18

Completion date

Unknown

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparotomy wound after closure of the fascia after visceral surgery

Interventions

Trade Name: Serasept Pharmaceutical Form: Cutaneous solution INN or Proposed INN: Polyhexanid Other descriptive name: POLYHEXANIDE SOLUTION 20% (SW/DAC) Concentration unit: % percent Concentration num

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with laparotomy including mini-laparotomy in elective visceral surgery Are the trial subjects under 18? no Number of subjects for this age range: 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 156

Exclusion criteria

Exclusion criteria: Patients aged < 18 years No ability understanding the patient information, the patient informed consent and the content of the study. Allergy against one of the substances Laparoscopic surgery Emergency Surgery

Design outcomes

Primary

Measure	Time frame
Main Objective: 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;Secondary Objective: Subcutaneous application of the antiseptic solution Serasept in elective laparotomies may reduce the colonization of the abdominal wall with bacteria compared to NaCl. Subcutaneous application of the antiseptic solution Serasept in elective laparotomies may reduce hospital stay compared to NaCl. Subcutaneous application of the antiseptic solution Serasept in elective laparotomies may reduce hospital costs compared to NaCl. ;Primary end point(s): rate of wound infections after abdominal surgery;Timepoint(s) of evaluation of this end point: 1 month after the surgery	—

Measure

Time frame

Main Objective: 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;Secondary Objective: Subcutaneous application of the antiseptic solution Serasept in elective laparotomies may reduce the colonization of the abdominal wall with bacteria compared to NaCl. Subcutaneous application of the antiseptic solution Serasept in elective laparotomies may reduce hospital stay compared to NaCl. Subcutaneous application of the antiseptic solution Serasept in elective laparotomies may reduce hospital costs compared to NaCl. ;Primary end point(s): rate of wound infections after abdominal surgery;Timepoint(s) of evaluation of this end point: 1 month after the surgery

—

Secondary

Measure	Time frame
Secondary end point(s): colonization of the abdominal wall with bacteria Hospital stay in-hospital costs;Timepoint(s) of evaluation of this end point: 1 month after surgery	—

Countries

Germany

Contacts

Public Contactstudy coordinator

Charité Universitätsmedizin

marja.leonhardt@charite.de004903084452948

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026