Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-28 @ 6:39 PM
Study NCT ID:
NCT04055233
Status:
COMPLETED
Last Update Posted:
2019-08-13
First Post:
2018-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction of Postoperative Wound Infections by Antiseptica?
Sponsor:
Johannes Lauscher
Organization:
Study Overview
Official Title:
Reduction of Postoperative Wound Infections by Antiseptica?
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECIPE
Brief Summary:
Wound infections are a frequent complication in abdominal surgery. The investigators hypothesize that the antiseptic solution 0.04 % polyhexanide (serasept) may reduce occurrence of postoperative wound infections compared to NaCL (saline) solution in a prospective randomized setting.
Detailed Description:
Invstigator initiated monocenter randomized controlled trial. Intraoperative irrigation of subcutaneous tissue with NaCl (saline) solution or antiseptic solution 0.04 % polyhexanide (Serasept) in elective abdominal surgery. Primary endpoint: SSI 30 days postoperatively according to CDC criteria.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: