Hepatobiliary DiseaseNPWTNCT05481398
A Randomized Controlled Trial Evaluating the Role of Negative Pressure Wound Therapy (NPWT) for Incisional Surgical Site Infections in Patients Undergoing Hepatopancreatobiliary Surgery
A study testing Negative Pressure Wound Therapy in people with Hepatobiliary Disease and Hepatobiliary Disorders, run by Murk Niaz at 1 site in Pakistan.
Trial summary
To compare the rates of incisional surgical site infections (iSSIs) within 7 days of hepatopancreatobiliary (HPB) surgery using negative pressure wound therapy (NWPT) versus using standard sterile gauze dressing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatobiliary Disease, Hepatobiliary Disorders, Surgical Site Infection
- What is being tested?
- Negative Pressure Wound Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Mar 2021to 1 Jul 2022
- 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
- All patients undergoing elective open HPB surgery (benign or malignant disease) of age > 18 years consenting to the study protocol.
Who cannot join
- The patient in which primary wound closure is not achieved. The patient planned for a second look surgery. The patient with the history of long-term antibiotic use (more than a month). Past history of open abdominal surgery (less than 1 month).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Negative Pressure Wound Therapy (NPWT) for Incisional Surgical Site Infections in Patients Undergoing Hepatopancreatobiliary Surgery: A Randomized Controlled Trial.
To compare the rates of incisional surgical site infections (iSSIs) within 7 days of hepatopancreatobiliary (HPB) surgery using negative pressure wound therapy (NWPT) versus using standard sterile gauze dressing.
- Being tested
- Negative Pressure Wound Therapy
- Keywords
- Hepatopancreatobiliary surgery, Surgical site infection, Negative pressure wound therapy
- Medical subject headings
- Digestive System Diseases, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound TherapyOther
The wound is dressed using negative pressure wound therapy comprising of a single layer of sterile gauze followed by placement of a 18 Fr nelaton catheter and the wound further covered with 4 more layers of sterile gauze over the nelaton catheter. The wound is then covered with opsite dressing making it airtight. The nelaton catheter is attached to the wall suction port once the patient is shifted to the bed with pressure set at - 25 mm Hg.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group A | Experimental | After the skin closed, negative pressure wound therapy will be applied. Receives: Other: Negative Pressure Wound Therapy |
| Control group B | No intervention | After the skin is closed, the wound is covered using sterile standard guaze dressing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of incisional surgical site infections (iSSIs)
To compare the rates of incisional surgical site infections (iSSIs) within 7 days of hepatopancreatobiliary (HPB) surgery using negative pressure wound therapy (NWPT) versus using standard sterile gauze dressing.
Measured: within 7 days of hepatopancreatobiliary (HPB) surgery
Secondary outcomes (5)
Wound infections
Wound infections after day 7 till 30 days following HPB surgery.
Measured: day 7 till 30 days following HPB surgery
Surgical site complication
Surgical site complication (hematoma/seroma/wound dehiscence) within 30 days of HPB surgery.
Measured: within 30 days of HPB surgery
Rate of fascial dehiscence
Rate of fascial dehiscence within 30 days of HPB surgery.
Measured: within 30 days of HPB surgery
Antibiotic therapy
Need for antibiotic therapy for iSSI beyond perioperative/postoperative surgical prophylaxis.
Measured: Day 1 to day 30
Length of hospital stay.
Length of hospital stay.
Measured: Day 1 to day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start6 Mar 2021
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatobiliary DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization Patients will be randomly allocated into intervention group A (NPWT) or control group (B) by simple randomization.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murk Niaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Murk Niaz, Sindh Institute of Urology and Transplantation
- Investigators
- Uzma Soomro, Principal investigator, Sindh Institute of Urology and Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481398
- Sponsor's protocol ID
- NPWT HPB
- Acronym
- NPWT
- Status last verified
- Jul 2022
- First submitted
- 28 Jul 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Pressure Wound Therapy (NPWT) for Incisional Surgical Site Infections in Patients Undergoing Hepatopancreatobiliary Surgery: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05481398
- Acronym / sponsor ID
- NPWT / NPWT HPB
- Keywords
- Hepatopancreatobiliary surgery, Surgical site infection, Negative pressure wound therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Murk NiazUniversity, hospital or other
- Study start
- 6 Mar 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 1 Aug 2022 (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.
To compare the rates of incisional surgical site infections (iSSIs) within 7 days of hepatopancreatobiliary (HPB) surgery using negative pressure wound therapy (NWPT) versus using standard sterile gauze dressing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization Patients will be randomly allocated into intervention group A (NPWT) or control group (B) by simple randomization.
| Arm | Type | Receives |
|---|---|---|
| Intervention group A | Experimental | Other: Negative Pressure Wound TherapyAfter the skin closed, negative pressure wound therapy will be applied. |
| Control group B | No intervention | –After the skin is closed, the wound is covered using sterile standard guaze dressing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing elective open HPB surgery (benign or malignant disease) of age > 18 years consenting to the study protocol.
Key exclusion criteria (1 listed)
- The patient in which primary wound closure is not achieved. The patient planned for a second look surgery. The patient with the history of long-term antibiotic use (more than a month). Past history of open abdominal surgery (less than 1 month).
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 |
|---|---|---|
| Negative Pressure Wound TherapyThe wound is dressed using negative pressure wound therapy comprising of a single layer of sterile gauze followed by placement of a 18 Fr nelaton catheter and the wound further covered with 4 more layers of sterile gauze over the nelaton catheter. The wound is then covered with opsite dressing making it airtight. The nelaton catheter is attached to the wall suction port once the patient is shifted to the bed with pressure set at - 25 mm Hg. | Other | Intervention group A |
Primary outcome
Rate of incisional surgical site infections (iSSIs)
Time frame: within 7 days of hepatopancreatobiliary (HPB) surgery
To compare the rates of incisional surgical site infections (iSSIs) within 7 days of hepatopancreatobiliary (HPB) surgery using negative pressure wound therapy (NWPT) versus using standard sterile gauze dressing.
5 secondary outcomes
Wound infections
Time frame: day 7 till 30 days following HPB surgery
Surgical site complication
Time frame: within 30 days of HPB surgery
Rate of fascial dehiscence
Time frame: within 30 days of HPB surgery
Antibiotic therapy
Time frame: Day 1 to day 30
Length of hospital stay.
Time frame: Day 1 to day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
Uzma Soomro principal investigator
Sindh Institute of Urology and Transplantation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Pressure Wound Therapy in people with Hepatobiliary Disease and Hepatobiliary Disorders, run by Murk Niaz at 1 site in Pakistan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Aug 2022. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of incisional surgical site infections (iSSIs) (time frame: within 7 days of hepatopancreatobiliary (HPB) surgery). 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 1 Aug 2022.