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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPWTi | Experimental | 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. |
|
| conventional NPWT | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPWTi | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Georgi Popivanov | Contact | +354885521241 | gerasimpopivanov@rocketmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ventsislav Mutafchiyski, DSc, FACS | Military Medical Academy, Bulgaria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Sugery | Recruiting | Sofia | 1606 | Bulgaria |
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|
| Conventional NPWT | Device | Conventional NPWT |
|
| 6 weeks |
| time to wound closure | the time elapsed from the start of the treatment to wound closure | 6 weeks |