Postoperative Wound Infection Superficial IncisionalNCT06014788
Is the NPWTi Better Than the Conventional NPWT
A study testing NPWTi and Conventional NPWT in people with Postoperative Wound Infection Superficial Incisional and Postoperative Wound Infection Deep Incisional Surgical Site, run by Military Medical Academy, Bulgaria at 1 site in Bulgaria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Wound Infection Superficial Incisional, Postoperative Wound Infection Deep Incisional Surgical Site
- What is being tested?
- NPWTi and Conventional NPWT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBulgaria
- Study dates
- 17 Jan 2018to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults over 18 years
- superficial or deep SSIs after laparotomy or laparoscopic surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site, 1 recruiting
- Recruiting
Department of Sugery
Sofia, 1606
Georgi Popivanov, PhD, +354885521241, gerasimpopivanov@rocketmail.com
Kirien Kjossev, PhD, kirienkt@gmail.com
About this study
Official title: NPWTi vs. Conventional NPWT in Superficial and Deep Abdominal Surgical Site Infections
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.
- Conditions
- Postoperative Wound Infection Superficial Incisional, Postoperative Wound Infection Deep Incisional Surgical Site
- Being tested
- NPWTi, Conventional NPWT
- Keywords
- NPWTi, conventional NPWT, superficial and deep SSIs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPWTiDevice
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 NPWTDevice
Conventional NPWT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: NPWTi |
| 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. Receives: Device: Conventional NPWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
eradication of the infection
(negative microbiology or bacterial count < 103)
Measured: 6 weeks
the rate of wound closure
the wound closure by suture or flap
Measured: 6 weeks
30-day recurrence rate
30-day recurrence rate of the infection
Measured: 30 days after discharge
Secondary outcomes (3)
hospital stay
hospital stay in days
Measured: 6 weeks
number of OR visits
number of OR visits and dressing changes under general anesthesia
Measured: 6 weeks
time to wound closure
the time elapsed from the start of the treatment to wound closure
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start17 Jan 2018
- Primary completionJun 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Wound Infection Superficial IncisionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military Medical Academy, Bulgaria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ventsislav Mutafchiyski, DSc, FACS, Principal investigator, Military Medical Academy, Bulgaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014788
- Sponsor's protocol ID
- 20.08.1964
- Status last verified
- Aug 2023
- First submitted
- 28 Jul 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NPWTi vs. Conventional NPWT in Superficial and Deep Abdominal Surgical Site Infections
- ClinicalTrials.gov ID
- NCT06014788
- Acronym / sponsor ID
- 20.08.1964
- Conditions
- Postoperative Wound Infection Superficial Incisional, Postoperative Wound Infection Deep Incisional Surgical Site
- Keywords
- NPWTi, conventional NPWT, superficial and deep SSIs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Military Medical Academy, BulgariaUniversity, hospital or other
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPWTi | Experimental | Device: NPWTiThe 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 | Device: Conventional NPWTThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults over 18 years
- superficial or deep SSIs after laparotomy or laparoscopic surgery
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPWTiThe 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. | Device | NPWTi |
| Conventional NPWTConventional NPWT | Device | conventional NPWT |
Primary outcome
eradication of the infection
Time frame: 6 weeks
(negative microbiology or bacterial count < 103)
the rate of wound closure
Time frame: 6 weeks
the wound closure by suture or flap
30-day recurrence rate
Time frame: 30 days after discharge
30-day recurrence rate of the infection
3 secondary outcomes
hospital stay
Time frame: 6 weeks
number of OR visits
Time frame: 6 weeks
time to wound closure
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ventsislav Mutafchiyski, DSc, FACS principal investigator
Military Medical Academy, Bulgaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NPWTi and Conventional NPWT in people with Postoperative Wound Infection Superficial Incisional and Postoperative Wound Infection Deep Incisional Surgical Site, run by Military Medical Academy, Bulgaria at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgi Popivanov (+354885521241, gerasimpopivanov@rocketmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eradication of the infection (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.