Antimicrobial approach of abdominal post-surgical infections

Table 4 Ongoing trials

Study name	ClinicalTrial.gov identifier	Design	Status	Type of surgery	Intervention(s)	Country
Iodine-Povidone Alcohol Compared to Chlorhexidine Alcohol as Preoperative Antiseptics in Major Abdominal Elective Clean Contaminated Surgery	NCT03859908	Single blind RCT	Terminated	Elective surgery categorized as clean contaminated surgery	Drug: Iodine povacrylex/isopropyl alcohol	El Salvador
					Drug: Chlorhexidine gluconate/isopropyl alcohol
Examination of the Effect of Skin Antisepsis with Pre-heated Povidone Iodine on Surgical Site Infections: A Quasi-Experimental Study	NCT04969302	Single blind RCT	Completed	NS	Experimental: Povidone-iodine will heat to 37 °C using a gel warmer	Greece
					Control: Povidone-iodine will heat to 20 °C using a gel warmer
Study to Assess the Safety & Efficacy of Oral Ciprodiazole Versus Currently Used Ciprofloxacin & Metronidazole (CIPRO-001)	NCT05863832	Open label RCT	Recruiting	Pelvi-abdominal surgery	Experimental	Egypt
					Ciprodiazole
					Active comparator: Ciprofloxacin 500 mg
PVP Iodine vs Chlorhexidine in Alcohol for Disinfection of the Surgical Site (PICASSo)	NCT03685604	Single blind RCT	Completed	Colorectal surgery, cholecystectomy, herniotomy, appendectomy and bariatric surgery	Active comparator: Braunoderm®	Switzerland
					Comparator
					Softasept®
Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients with Surgical Site Infections (DRESS)	NCT04042077	Single blind RCT	Terminated	Abdominal surgery	Drug: Delafloxacin	Rome
					Drug: Vancomycin
					Drug: Linezolid
					Drug: Piperacillin/tazobactam
					Drug: Tigecycline
A Randomized, Blinded, Placebo and Standard of Care Controlled Efficacy, Safety, and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery	NCT01888367	Triple blind RCT	Completed	Abdominal surgery	Drug: DFA-02 Antibiotic Gel	United States
					Drug: DFA-02 Placebo Gel
Reduction of Postoperative Wound Infections by Antiseptica? (RECIPE)	NCT04055233	Double blind RCT	Completed	Laparotomy for visceral surgery	Drug: Polihexanide; Serasept	Germany
					Drug: NaCl; saline
Study of Chlorhexidine Gluconate as a Preoperative Antisepsis (CHG)	NCT01495117	Quadruple blind RCT	Completed	Resection surgery (clean-contaminated open surgery)	Drug: Povidone-Iodine	Republic of Korea
					Drug: Chlorhexidine gluconate
A Randomized Controlled Trial of 2% Chlorhexidine Gluconate Skin Preparation Cloths for the Prevention of Post-Operative Surgical Site Infections in Colorectal Patients	NCT02385708	Open label RCT	Completed	Colorectal surgery	Drug: 2% chlorohexidine gluconate standard of care	United States
					Drug: 2% chlorohexidine gluconate chin to toe
Effect of Peritoneal Lavage with Clindamycin-gentamicin Solution on Postoperative Colorectal Cancer Infection in Elective Surgery	NCT01378832	Open label RCT	Completed	Colorectal surgery	Procedure: Intra-peritoneal antibiotic lavage	No location data
Collagen-Gentamicin Implant in the Treatment of Contaminated Surgical Abdominal Wounds - A Randomized Controlled Trial	NCT00977405	Double blind RCT	Terminated	Abdominal surgery	Device: Collatamp gentamicin implant	Singapore
CLinical Evaluation of Adults UNdergoing Elective Surgery Utilizing Intraoperative Incisional Wound Irrigation: A Randomized Controlled Trial (CLEAN Wound)	NCT04548661	Double blind RCT	Not yet recruiting	Laparotomy (clean-contaminated or contaminated incision). Laparoscopy (clean-contaminated or contaminated incision)	Procedure: Intraoperative incisional wound irrigation with povidone-iodine solution	Canada
					Procedure: Intraoperative incisional wound irrigation with saline
Randomized Controlled Trial to Evaluate the Optimal Timing of Surgical Antimicrobial Prophylaxis	NCT01790529	Quadruple blind RCT	Completed	Colorectal surgery	Procedure: Cefuroxime + metronidazole 75 to 30 min prior to skin incision	Switzerland
					Procedure: Cefuroxime + metronidazole within 30 min prior to skin incision)
A Pilot Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep™	NCT02221232	Open label pilot study	Terminated	NS	Drug: Chloraprep	United States
					Drug: ZuraPrep
					Drug: ZuraPrep Vehicle
ROSSINI 2 - Reduction of Surgical Site Infection Using Several Novel Interventions (ROSSINI 2)	NCT03838575	Double blind RCT	Recruiting	Colorectal, hepatobiliary, upper GI, urological, vascular, or gynecological	Drug: 2% alcoholic chlorhexidine skin prep (SKIN PREP)	United Kingdom
					Device: Iodophor Antimicrobial Incise Drapes (DRAPE)
					Device: Gentamicin-impregnated implants/sponges (SPONGE)
					Other: None (control)
D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD I)	NCT04233424	Triple blind RCT	Completed	Elective colorectal surgery	Drug: D-PLEX (new formulation of extended release of doxycycline)	United States
					Other: SoC
D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)	NCT04411199	Triple blind RCT	Recruiting	Elective colorectal surgery	Drug: D-PLEX + SoC	United States, Hungary, Serbia, Poland, Israel
					Other: SoC
Abdomen Closure Using Triclosan Coated Absorbable Suture vs Uncoated Sutures of the Same Base Material	NCT01620294	Double blind RCT	Completed	Elective colorectal surgery	Procedure: Abdominal wall closure	Hungary
					Procedure: Surgical site infection
Prophylaxis of Surgical Wound Infection with Topical Antibiotics	NCT04476212	Triple blind RCT	Recruiting	Elective abdominal wall surgery	Drug: Amoxicillin-clavulanate for topical prophylaxis	Spain
				Elective and emergency colorectal surgery	No intervention: Control
D-PLEX 310: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection	NCT03633123	Single blind RCT	Completed	Elective colorectal surgery	Drug: D_PLEX	Israel
					Other: SoC
Antibiotic Prophylaxis in the Prevention of Surgical Site Infections After Selected Urgent Abdominal Surgical Procedures	NCT01524081	Double blind RCT	Completed	Emergent surgery for: Acute appendicitis/perforated gastric or duodenal ulcer/small bowel obstruction	Drug: Metronidazole, cefuroxime	Czech Republic
					Drug: Amoxicillin (+ clavulanic acid) and fluconazole
					Drug: Placebo
					Drug: Placebo
Study the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Infection in Colorectal Surgery (PROTOP)	NCT03574090	Triple blind RCT	Completed	Colorectal surgery	Drug: Amoxicillin clavulanate	Spain
					Drug: Physiological saline
Parenteral Antibiotics Compared to Combination of Oral and Parenteral Antibiotics in Colorectal Surgery Prophylaxis (ORALEV)	NCT02505581	Quadruple blind RCT	Completed	Colorectal surgery	Drug: Extra dosage - cefuroxime (750 mg) intravenous	Spain
					Drug: Ciprofloxacin 750 mg oral
					Drug: Metronidazole 250 mg oral
					Drug: Cefuroxime 1.5 g intravenous
					Drug: Metronidazole 1 g intravenous
Impact of Triclosan-coated Suture on Surgical Site Infection After Colorectal Surgery	NCT01869257	Single blind RCT	Completed	Colorectal surgery	Device: Triclosan coated suture	Italy
					Device: Regular suture
Intravenous Versus Combined Oral and Intravenous Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Elective Colorectal Surgery (COMBINE)	NCT02618720	Double blind RCT	Completed	Elective colorectal surgery	Drug: Ornidazole	France
					Drug: Placebo
Prophylactic Effect Preoperative Antibiotics with Mechanical Bowel Preparation in SSIs	NCT03856671	Open label RCT	Completed	Laparoscopic colorectal surgery	Drug: Neomycin, metronidazole	China
Frequency of Surgical Site Infection in Abdominal Hernia with Gentamycin Spray on Mesh Versus no Spray	NCT04164524	Case-Control trial	Completed	Elective surgery; Para umbilical hernia, umbilical and epigastric hernia,	Drug: Gentamycin 160 mg spray applied over the mesh	Pakistan
Antibiotic Instillation in Acute Complex Appendicitis for Prevention of Deep Space Surgical Site Infections	NCT05470517	Single blind RCT	Recruiting	Appendectomy	Drug: Ceftriaxone	United States
					Procedure: Intra-peritoneal fluid aspiration
Prophylaxis of Surgical Wound Infection in Incisional Hernia Repair With Topical Antibiotics (PROTOP-PAR)	NCT05508152	Triple blind RCT	Recruiting	Elective surgical procedure due to an abdominal wall incisional hernia	Drug: Wound irrigation with amoxicillin-clavulanate in saline solution	Spain
					Drug: Wound irrigation with a saline solution
Orally Administered Trimethoprim-sulfamethoxazole and Metronidazole as Prophylaxis of Infection Following Elective Colorectal Surgery	NCT00613769	Triple blind RCT	Completed	Colorectal surgery	Drug: Trimethoprim-sulfamethoxazole + metronidazole	Sweden
					Drug: Cefuroxime and metronidazole
The Effect of Intraoperative Peritoneal Lavage With Super-Oxidized Solution on Surgical Site Infections and Mortality in Patients With Secondary Peritonitis: A Randomized Controlled Trial	NCT05050253	Open label RCT	Recruiting	Emergency abdominal surgery by laparotomy	Device: Super-oxidized solution	Switzerland
					Device: Ringer’s solution
Reducing INfection at the Surgical SitE With Antibiotic Irrigation During Ventral Hernia Repair (RINSE Trial)	NCT03945357	Open label RCT	Completed	Elective, open ventral hernia repair	Drug: Gemcitabine/clindamycin	United States
					Drug: Normal saline
Preoperative Oral Antibiotics With vs Without Mechanical Bowel Preparation to Reduce Surgical Site Infections Following Colonic Resection: an International Randomized Controlled Trial. (ORALEV2)	NCT04161599	Single blind RCT	Recruiting	Colectomy	Drug: Cefuroxime (750 mg) intravenous	China
					Drug: Cefuroxime 750 mg oral	Italy
					Drug: Metronidazole 250 mg oral tablet	Spain
					Drug: Metronidazole 1 g intravenous	Russia
					Drug: Cefuroxime 1.5 g intravenous	Greece
					Drug: Sodium picosulfate, light magnesium oxide, anhydrous citric acid 10 mg/3.5 g/10.97 g oral	United Kingdom
Standard Versus Pre-emptive Antibiotic Treatment to Reduce the Rate of Infectious Outcomes After Whipple’s Procedure (SPARROW): a Multicenter, Randomized Controlled Trial	NCT05784311	Open label RCT	No yet recruiting	Elective pancreatoduodenectomy	Drug: Cefuroxime	Netherlands
					Drug: Metronidazole

NS: Not specified; RCT: Randomized controlled trial; SoC: Standard of care.