Ongoing Clinical Trials for Postoperative Wound Infection
Currently, there are 3 ongoing clinical trials investigating ways to prevent and treat postoperative wound infections. These studies are exploring the use of oral antibiotics before surgery, bacteriophage-based treatments, and a powder medication applied directly to surgical wounds. The trials are being conducted across multiple European countries and aim to improve outcomes for patients undergoing abdominal and colorectal surgeries.
Clinical trial locations
- Czechia
- Germany
- Hungary
- Ireland
- Italy
- Poland
- Portugal
- Romania
Study on Erythromycin and Neomycin for Preventing Infections After Colorectal Surgery in Patients Undergoing Elective Procedures
This study is being conducted in Ireland and focuses on preventing infections at the surgical site following planned colorectal surgery. Colorectal surgery involves operations on the colon or rectum, and these types of procedures carry a risk of infection that can delay healing and cause additional complications.
Who can participate: The trial is open to adults aged 18 years and older who are scheduled for elective surgery on their colon or rectum. This includes surgeries performed using laparoscopic techniques with small cuts and a camera, open surgery with larger incisions, or robotic-assisted procedures. The surgery may be for benign conditions or cancer. Both men and women can join the study.
Who cannot participate: Patients who are not scheduled for planned colorectal surgery or who fall outside the specified age range cannot take part. Those who belong to vulnerable populations requiring special care, patients unable to take oral antibiotics, or those who need mechanical bowel preparation to clean out the intestines before surgery are also excluded.
What the trial involves: The study aims to determine whether taking oral antibiotics before surgery can reduce the risk of infection at the surgical site without the need for bowel preparation procedures. Participants will receive two antibiotics in tablet form: erythromycin and neomycin. Erythromycin Tablets BP 250mg and Neomycin 500mg Tablets are administered by mouth before the operation. Some participants will receive these antibiotics while others will receive a placebo that looks like the medication but contains no active ingredients. This comparison helps researchers understand the true effectiveness of the antibiotics.
Main goal: The primary focus is to see if these oral antibiotics can lower the chances of developing surgical site infections after colorectal surgery. Researchers will also monitor for other infectious complications, measure how long patients stay in the hospital, and track any postoperative issues using the Clavien Dindo classification system. The trial will also observe for anastomotic leakage, which is when the surgical connection between parts of the intestine breaks down.
Study on the Safety and Effectiveness of Sodium Chloride and Bacteriophage for Treating Surgical Wound Infections in Patients
This trial is taking place in Czechia and focuses on treating existing infections in surgical wounds caused by two specific types of bacteria: Staphylococcus aureus and Pseudomonas aeruginosa. These bacteria are common causes of wound infections after surgery and can significantly delay healing.
Who can participate: Adults between 18 and 75 years of age who have a surgical wound infection or dehiscence, where the wound has opened up, can join this study. The infection must be confirmed by a wound swab test showing the presence of S. aureus or P. aeruginosa bacteria. The wound should be located in the groin or another skin fold area. Participants must be able to follow the study procedures and should have experienced symptoms of bacterial infection for less than 3 weeks since their surgery. Women who can become pregnant must use highly effective birth control throughout the study and for at least one month after treatment ends.
Who cannot participate: Patients outside the specified age range or those from vulnerable populations requiring special protection cannot participate. Anyone unable to commit to the study procedures will also be excluded.
What the trial involves: Participants will receive a treatment called DUOFAG, which is applied directly to the infected wound as a topical application. The treatment continues for up to 10 weeks or until the wound heals. Throughout this period, the wound will be regularly monitored with up to 8 swab assessments to track changes in the types of bacteria present. Both local reactions at the wound site and any body-wide symptoms will be carefully recorded.
Main goal: The study aims to determine whether DUOFAG is safe to use and whether it can effectively eliminate the bacterial infection and promote wound healing. Researchers will assess changes in the wound’s condition, monitor for any side effects, and determine if the bacteria are successfully cleared from the infection site.
Study on Preventing Infections After Abdominal Surgery Using D-PLEX with Doxycycline Hyclate for Patients Undergoing Abdominal Surgery
This large international trial is being conducted across seven European countries: Poland, Ireland, Germany, Hungary, Romania, Portugal, and Italy. It focuses on preventing infections at the incision site following abdominal surgery, specifically colorectal operations.
Who can participate: The trial is open to adults aged 18 years and older who are undergoing planned colorectal surgery involving a large abdominal incision longer than 20 centimeters. This may include removing part of the large intestine, with or without creating a stoma, which is an opening on the abdomen. Patients must be in stable condition before surgery, with normal blood pressure, heart rate, and body temperature. Women who can become pregnant must have a negative pregnancy test and agree to use reliable contraception during the study. Participants should have a life expectancy of at least 60 days and be willing to follow all study requirements.
Who cannot participate: Patients with known allergies to the study medication or its components cannot join. Those currently participating in another clinical trial, individuals with a history of severe allergic reactions, or patients with a weakened immune system are excluded. Pregnant or breastfeeding women, people with a history of drug or alcohol abuse, and those with significant liver or kidney disease cannot participate. Patients with uncontrolled diabetes, recent heart attacks or strokes, or any other condition that doctors believe would make participation unsafe are also excluded.
What the trial involves: During surgery, a product called D-PLEX is used. It comes as a powder that is mixed into a paste and implanted directly at the surgical site. The active ingredient is doxycycline hyclate, an antibiotic substance. Participants are randomly assigned to receive either standard post-surgery care alone or standard care plus D-PLEX treatment. The study is double-blind, meaning neither participants nor researchers know who receives which treatment until the study ends. This design helps ensure that the results are not influenced by expectations.
Main goal: The primary objective is to measure whether D-PLEX can reduce the rate of infections at the incision site within 30 days after surgery. This includes both superficial infections affecting only the skin and deeper infections involving muscles and surrounding tissues. An independent committee evaluates all infections to ensure unbiased results. Secondary outcomes include assessing the overall infection rate, the need for additional surgeries, and the presence of antibiotic-resistant bacteria. The trial is expected to continue until the end of 2024.
Summary
The three ongoing clinical trials for postoperative wound infection represent different approaches to addressing this important surgical complication. Two trials focus on prevention strategies while one addresses treatment of established infections. A notable observation is the geographic concentration of studies, with Ireland participating in two trials and the D-PLEX study being the most widely distributed across seven European countries including Poland, Germany, Hungary, Romania, Portugal, and Italy.
The trials demonstrate diverse therapeutic approaches. Two studies test antibiotic-based interventions: oral antibiotics taken before surgery in the Irish colorectal study, and D-PLEX containing doxycycline hyclate implanted during surgery in the multi-country trial. The Czech study takes a different approach by investigating DUOFAG, a bacteriophage-based treatment applied topically to existing infections. Each trial targets specific surgical contexts, with colorectal surgeries being the focus of two studies and surgical wounds in skin folds being addressed by the third.
These trials reflect the ongoing medical challenge of managing surgical infections and the search for effective prevention and treatment methods. The variety of approaches being tested suggests that researchers are exploring multiple pathways to improve patient outcomes following surgery.
