Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
100 participants
INTERVENTIONAL
2018-01-17
2024-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Researchers will compare the two groups to see if NPWTi diminishes the rate of recurrent infections and the number of reoperations, shortens the hospital stay, and alleviates the burden on the hospital staff in comparison to the conventional NPWT.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Closed Incision Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections in Abdominal Surgery
NCT06068517
NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT
NCT05338281
Study to Analyze the Surgical Site Infections in a Group of Patients Who Were Randomly Applied a Negative Pressure Therapy Dressing Versus Conventional Dressing
NCT05455801
Prophylaxis of Surgical Wound Infection With Topical Antibiotics
NCT04476212
NPWT vs Primary Closure in SSI Prevention for Emergency Laparotomies for Peritonitis
NCT05684198
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
NPWTi
The whole wound was filled with black foam (Granufoam®, KCI). The instillation was performed via gravity from i.v. bag through a drain put within the foam. Chlorhexidine 0.1% 300 ml in 700 ml saline was used for continuous instillation three times daily (3 L per day) on the background of continuous pressure of 125 mmHg. The dressing changes were performed every 48-72 hours.
NPWTi
The wound was filled with black foam (Granufoam®, KCI). The instillation was performed via gravity from i.v. bag through a drain put within the foam. Chlorhexidine 0.1% 300 ml in 700 ml saline was used for continuous instillation three times daily (3 L per day) on the background of continuous pressure of 125 mmHg.
conventional NPWT
The wound was filled with black foam (Granufoam®, KCI) and covered with plastic folio. A continuous pressure of 125 mmHg was applied using the hospital suction system. The dressing changes were performed every 48 hours.
Conventional NPWT
Conventional NPWT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NPWTi
The wound was filled with black foam (Granufoam®, KCI). The instillation was performed via gravity from i.v. bag through a drain put within the foam. Chlorhexidine 0.1% 300 ml in 700 ml saline was used for continuous instillation three times daily (3 L per day) on the background of continuous pressure of 125 mmHg.
Conventional NPWT
Conventional NPWT
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* superficial or deep SSIs after laparotomy or laparoscopic surgery
Exclusion Criteria
* documented inherited or acquired coagulation disorders or platelet deficiency
* presence of deep space infection (intra-abdominal abscess or ongoing peritonitis)
* prosthetic material infection
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Military Medical Academy, Bulgaria
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ventsislav Mutafchiyski, DSc, FACS
Role: PRINCIPAL_INVESTIGATOR
Military Medical Academy, Bulgaria
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Sugery
Sofia, , Bulgaria
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20.08.1964
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.