Is the NPWTi Better Than the Conventional NPWT

Study Overview
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Brief Summary
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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.

Official Title
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NPWTi vs. Conventional NPWT in Superficial and Deep Abdominal Surgical Site Infections

Conditions
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Postoperative Wound Infection Superficial Incisional, Postoperative Wound Infection Deep Incisional Surgical Site

Intervention / Treatment
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* Device: NPWTi
* Device: Conventional NPWT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPWTi<br>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. | Device: NPWTi<br>* 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.<br>|
| Active Comparator: conventional NPWT<br>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. | Device: Conventional NPWT<br>* Conventional NPWT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eradication of the infection | (negative microbiology or bacterial count < 103) | 6 weeks | 
| the rate of wound closure | the wound closure by suture or flap | 6 weeks | 
| 30-day recurrence rate | 30-day recurrence rate of the infection | 30 days after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital stay | hospital stay in days | 6 weeks | 
| number of OR visits | number of OR visits and dressing changes under general anesthesia | 6 weeks | 
| time to wound closure | the time elapsed from the start of the treatment to wound closure | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NPWTi, conventional NPWT, superficial and deep SSIs