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Completed

NCT Number: NCT04055233

Reduction of Postoperative Wound Infections by Antiseptica?

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.

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Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Charité Campus Benjamin Franklin

Steglitz, State of Berlin, 12200, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polihexanide; Serasept

Drug

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)

NaCl; saline

Drug

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)

Primary outcomes

  1. surgical site infection

    Time frame: 30 days postoperatively

    Surgical site infection according to CDC definition.

Sponsors and collaborators

Lead sponsor

Johannes Lauscher

Other

Registry information

Acronym: RECIPE

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 13, 2019
Registry last updated
Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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