RECIPE: Reduction of Postoperative Wound Infections by Antiseptica?

Sponsor

Johannes Lauscher (Other)

Overall Status

Completed

CT.gov ID

NCT04055233

Collaborator

(none)

456

Enrollment

Location

Arms

44.6

Actual Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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).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 :

Feb 1, 2015

Actual Primary Completion Date :

Sep 10, 2018

Actual Study Completion Date :

Oct 20, 2018

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

surgical site infection [30 days postoperatively]
Surgical site infection according to CDC definition.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charité Campus Benjamin Franklin	Berlin-Steglitz	Berlin	Germany	12200

Sponsors and Collaborators

Johannes Lauscher

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

Other Study ID Numbers: