Reduction of Postoperative Wound Infections by Antiseptica?

NCT ID: NCT04055233

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 456 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-01
• Study Completion Date: 2018-10-20

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.

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.

Conditions

Surgical Site Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Polihexanide; Serasept

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

NaCl; saline

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Polihexanide (0.04% antiseptic solution); NaCl (saline)

Eligibility Criteria

Exclusion Criteria

• Age under 18 years
• allergy against polihexanid
• laparoscopic surgery
• emergency surgery
• lack of understanding of the trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johannes Lauscher

OTHER

Sponsor Role: lead

Responsible Party

Johannes Lauscher

Principal investigator, MD, PhD, Staff surgeon, Department of General, Visceral and Vascular Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Johannes C Lauscher, MD

Role: PRINCIPAL_INVESTIGATOR

Charité-University Medicine (Berlin, Germany)

Locations

Charité Campus Benjamin Franklin

Steglitz, State of Berlin, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 35263172 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31599810 (View on PubMed)

Other Identifiers

2014-001551-22

Identifier Type: -

Identifier Source: org_study_id