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Reduction of Postoperative Wound Infections by Antiseptica? (RECIPE)

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ClinicalTrials.gov Identifier: NCT04055233
Recruitment Status : Completed
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Johannes Lauscher, Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Drug: Polihexanide; Serasept Drug: NaCl; saline Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 456 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two arm prospective randomized single center interventional trial. 1:1 randomization into experimental arm (irrigation with polyhexanide) and control arm (irrigation with saline).
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reduction of Postoperative Wound Infections by Antiseptica?
Actual Study Start Date : February 1, 2015
Actual Primary Completion Date : September 10, 2018
Actual Study Completion Date : October 20, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: NaCl (saline)




Primary Outcome Measures :
  1. surgical site infection [ Time Frame: 30 days postoperatively ]
    Surgical site infection according to CDC definition.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04055233


Locations
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Germany
Charité Campus Benjamin Franklin
Berlin-Steglitz, Berlin, Germany, 12200
Sponsors and Collaborators
Johannes Lauscher
Investigators
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Principal Investigator: Johannes C Lauscher, MD Charité University Medicine Berlin, Germany

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Responsible Party: Johannes Lauscher, Principal investigator, MD, PhD, Staff surgeon, Department of General, Visceral and Vascular Surgery, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04055233     History of Changes
Other Study ID Numbers: 2014-001551-22
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Biguanides
Anti-Infective Agents, Local
Polihexanide
Pharmaceutical Solutions
Anti-Infective Agents
Disinfectants
Hypoglycemic Agents
Physiological Effects of Drugs