Postoperative Wound Infection Deep Incisional Surgical Site, Postoperative Wound Infection Superficial Incisional
Conditions
Keywords
NPWTi, conventional NPWT, superficial and deep SSIs
Brief summary
The goal of this clinical trial is to compare the effectiveness of NPWTi and NPWT in superficial and deep surgical site infections using an improvised system with continuous lavage with saline and chlorhexidine. The main question it aims to answer is whether the NPWTi is better than conventional NPWT. Participants will be given NPWTi or conventional NPWT. 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.
Interventions
DEVICENPWTi
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.
DEVICEConventional NPWT
Conventional NPWT
Sponsors
Military Medical Academy, Bulgaria
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| eradication of the infection | 6 weeks | (negative microbiology or bacterial count \< 103) |
| the rate of wound closure | 6 weeks | the wound closure by suture or flap |
| 30-day recurrence rate | 30 days after discharge | 30-day recurrence rate of the infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hospital stay | 6 weeks | hospital stay in days |
| number of OR visits | 6 weeks | number of OR visits and dressing changes under general anesthesia |
| time to wound closure | 6 weeks | the time elapsed from the start of the treatment to wound closure |
Countries
Bulgaria
Contacts
Primary ContactGeorgi Popivanov
Outcome results
None listed