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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
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
Department of Sugery
Sofia, Bulgaria
RECRUITINGeradication of the infection
(negative microbiology or bacterial count \< 103)
Time frame: 6 weeks
the rate of wound closure
the wound closure by suture or flap
Time frame: 6 weeks
30-day recurrence rate
30-day recurrence rate of the infection
Time frame: 30 days after discharge
hospital stay
hospital stay in days
Time frame: 6 weeks
number of OR visits
number of OR visits and dressing changes under general anesthesia
Time frame: 6 weeks
time to wound closure
the time elapsed from the start of the treatment to wound closure
Time frame: 6 weeks
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