Comparing two methods for treating surgical site infections
NPWTi vs. Conventional NPWT in Superficial and Deep Abdominal Surgical Site Infections
NA · Military Medical Academy, Bulgaria · NCT06014788
This study is testing if a new wound treatment called NPWTi works better than the standard method for helping people recover from surgical site infections after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Military Medical Academy, Bulgaria (other) |
| Locations | 1 site (Sofia) |
| Trial ID | NCT06014788 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of NPWTi, an improvised negative pressure wound therapy with continuous lavage, against conventional NPWT in treating superficial and deep surgical site infections following laparotomy or laparoscopic surgery. Participants will be randomly assigned to receive either NPWTi or conventional NPWT, and researchers will assess outcomes such as infection recurrence rates, reoperation frequency, hospital stay duration, and overall impact on hospital staff workload. The study seeks to determine if NPWTi offers significant advantages over the traditional method.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years who have developed superficial or deep surgical site infections after abdominal surgery.
Not a fit: Patients under 18 years or those with coagulation disorders, deep space infections, or infections involving prosthetic materials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes for patients with surgical site infections, reducing complications and hospital stays.
How similar studies have performed: While this approach is innovative, similar studies comparing NPWT methods have shown promising results, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adults over 18 years * superficial or deep SSIs after laparotomy or laparoscopic surgery Exclusion Criteria: * persons \< 18 years * documented inherited or acquired coagulation disorders or platelet deficiency * presence of deep space infection (intra-abdominal abscess or ongoing peritonitis) * prosthetic material infection
Where this trial is running
Sofia
- Department of Sugery — Sofia, Bulgaria (RECRUITING)
Study contacts
- Principal investigator: Ventsislav Mutafchiyski, DSc, FACS — Military Medical Academy, Bulgaria
- Study coordinator: Georgi Popivanov
- Email: gerasimpopivanov@rocketmail.com
- Phone: +354885521241
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postoperative Wound Infection Superficial Incisional, Postoperative Wound Infection Deep Incisional Surgical Site, NPWTi, conventional NPWT, superficial and deep SSIs