drugset / Trial / NCT04055233
Reduction of Postoperative Wound Infections by Antiseptica?
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2015-02-01
- Primary completion
- 2018-09-10
- Completion
- 2018-10-20
Outcome
Met primary endpoint
paper Simple analysis with cross tabulation revealed that significantly fewer SSIs occurred in the polyhexanide group: n = 70 (34.7%) versus n = 41 (21.5%); P = 0.004. PMID 31599810 ↗
Publications
- Strobel RM, Leistner R, Leonhardt M, Neumann K, Eschlbock SM, Lee LDG, Seifarth C, Schineis CHW, Kamphues C, Weixler B, Beyer K, Lauscher JC. Is There an Association between Intra-Operative Detection of Pathogens in Subcutaneous Tissue and Surgical Site Infections? Results from a Prospective Study. Surg Infect (Larchmt). 2022 May;23(4):372-379. doi: 10.1089/sur.2021.154. Epub 2022 Mar 9.
- Strobel RM, Leonhardt M, Krochmann A, Neumann K, Speichinger F, Hartmann L, Lee LD, Beyer K, Daum S, Kreis ME, Lauscher JC. Reduction of Postoperative Wound Infections by Antiseptica (RECIPE)?: A Randomized Controlled Trial. Ann Surg. 2020 Jul;272(1):55-64. doi: 10.1097/SLA.0000000000003645.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | NaCl (saline) | Unknown | 250 ml | Other |
| Subject | Polihexanide | Other / unclassified | 0.04 % | Other |
| Subject | Polihexanide | Other / unclassified | 250 ml | Other |
Indications
No indication recorded.