Reduction of Postoperative Wound Infections by Antiseptica? (RECIPE)

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.

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.

Two arm prospective randomized single center interventional trial. 1:1 randomization into experimental arm (irrigation with polyhexanide) and control arm (irrigation with saline).

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.

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.

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.

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.

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

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.

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.