Reduction of Postoperative Wound Infections by Antiseptica? (RECIPE)

Johannes Lauscher

Status and phase: Completed; Phase 3

Conditions: Surgical Site Infection

Treatments: Drug: Polihexanide; Serasept; Drug: NaCl; saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04055233

2014-001551-22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 456 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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456 participants in 2 patient groups

Subcutaneous irrigation with 0.04% polyhexanide solution

Experimental group

Description:

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.

Treatment:

Drug: Polihexanide; Serasept

Subcutaneous irrigation with NaCl (saline)

Active Comparator group

Description:

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.

Treatment:

Drug: NaCl; saline