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.