Reduction of Postoperative Wound Infections by Antiseptica?

Surgical Site Infection Clinical Trial

— RECIPE  

Official title:

Reduction of Postoperative Wound Infections by Antiseptica?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04055233
• Other study ID #: 2014-001551-22
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2015
• Est. completion date: October 20, 2018

Study information

• Verified date: August 2019
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 456
• Est. completion date: October 20, 2018
• Est. primary completion date: September 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: - planned laparotomy for visceral surgery

Exclusion Criteria:

• Age under 18 years

• allergy against polihexanid

• laparoscopic surgery

• emergency surgery

• lack of understanding of the trial

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Site Infection
• Surgical Wound Infection
• Wound Infection

Intervention

Drug:
• Polihexanide; Serasept
Experimental arm: irrigation of subcutaneous tissue after fascia closure with polihexanide (ten minutes). A single dose of perioperative antibiotics (cefuroxim alone or cefuroxim and metrodidazole in bowel surgeries) was given 30 minutes before skin incision. Hair removal was done with electronic clippers and preoperative skin antisepsis was performed with propanol and povidone-iodine. Before closure of fascia, instruments and gloves were changed. No subcutaneous suture was used. Skin was closed either with skin staples, continuous intracutaneous suture or interrupted suture. All surgeries were done according to the Standard Operating Procedures of the Department for General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin.
• NaCl; saline
Control arm: irrigation of subcutaneous tissue after fascia closure with NaCl (one minute) A single dose of perioperative antibiotics (cefuroxim alone or cefuroxim and metrodidazole in bowel surgeries) was given 30 minutes before skin incision. Hair removal was done with electronic clippers and preoperative skin antisepsis was performed with propanol and povidone-iodine. All surgeries were done according to the Standard Operating Procedures of the Department for General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin. Before closure of fascia, instruments and gloves were changed. No subcutaneous suture was used. Skin was closed either with skin staples, continuous intracutaneous suture or interrupted suture. All surgeries were done according to the Standard Operating Procedures of the Department for General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin.

Locations

Country	Name	City	State
Germany	Charité Campus Benjamin Franklin	Berlin-Steglitz	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Lauscher

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgical site infection	Surgical site infection according to CDC definition.	30 days postoperatively