Reduction of Postoperative Wound Infections by Antiseptica? (RECIPE)

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.

Study Overview

• Status: Completed
• Conditions: Surgical Site Infection
• Intervention / Treatment: Drug: Polihexanide; Serasept; Drug: NaCl; saline

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 Type: Interventional
• Enrollment (Actual): 456
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin
    • Berlin-Steglitz, Berlin, Germany, 12200
      • Charite Campus Benjamin Franklin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subcutaneous irrigation with 0.04% polyhexanide solution; Intervention: after closure of abdominal fascia, an intraoperative irrigation of the subcutaneous tissue with 250 ml antiseptic solution (0.04% polyhexanide) will be done once for ten minutes. No subcutaneous suture. Closure of skin with either staples, interrupted sutures or running suture.	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.; Other Names: Polihexanide (0.04% antiseptic solution)
Active Comparator: Subcutaneous irrigation with NaCl (saline); Intervention: after closure of fascia, an intraoperative irrigation of the subcutaneous tissue with 250 ml NaCl (saline) will be done once for one minute. No subcutaneous suture. Closure of skin with either staples, interrupted sutures or running suture.	Drug: 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.; Other Names: NaCl (saline)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgical site infection	Surgical site infection according to CDC definition.	30 days postoperatively

Collaborators and Investigators

• Sponsor: Johannes Lauscher
• Investigators: Principal Investigator: Johannes C Lauscher, MD, Charité-University Medicine (Berlin, Germany)

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): September 10, 2018
• Study Completion (Actual): October 20, 2018

Study Registration Dates

• First Submitted: April 25, 2018
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Infections; Communicable Diseases; Surgical Wound Infection; Wound Infection; Hypoglycemic Agents; Physiological Effects of Drugs; Anti-Infective Agents; Disinfectants; Polihexanide; Biguanides
• Other Study ID Numbers: 2014-001551-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No