WoundNCT06957964
Prophylactic Negative Pressure Wound Therapy in Laparotomy Wounds: A Randomized Clinical Trial
A study testing Negative Pressure Wound Therapy and Standard Antibiotic Treatment in people with Wound and Infection Prevention, run by Dr Hamail Khanum at 1 site in Pakistan.
Trial summary
Total 70 participants meeting selection criteria will be enrolled in the study from operational theatre. They will be randomly divided in two groups by using lottery method. In group A, Negative Pressure Wound Therapy will be applied at end of procedure. In group B, no Negative Pressure Wound Therapy will be placed. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Wound, Infection Prevention, Negative Pressure Wound Therapy
- What is being tested?
- Negative Pressure Wound Therapy and Standard Antibiotic Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Mar 2025to 25 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of age between 20 to 70 years, both genders
- Undergoing laparotomy under general anaesthesia
- ASA I-II
Who cannot join
- Patients who did not complete the follow up instructions
- Pregnant patients
- Patients already undergone a relook laparotomy, if their abdomen is left open or if unable to adhere
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Gulab Devi Hospital Lahore
Lahore, Punjab Province, 05307
Prof Dr Maratab Ali, MBBS, FCPS, maratabali@hotmail.com
About this study
Total 70 participants meeting selection criteria will be enrolled in the study from operational theatre. They will be randomly divided in two groups by using lottery method. In group A, Negative Pressure Wound Therapy will be applied at end of procedure. In group B, no Negative Pressure Wound Therapy will be placed. They will be shifted to post-surgical wad for 72 hours and then will be discharged with prescription of standard antibiotics and will be followed-up in OPD for 30 days. If patient will develop surgical site wound infection, then it will be noted. If infection will not be cured with antibiotics course, then re-operation will be done. Patients complications will be managed as per hospital protocol. All this information will be recorded in proforma.
- Conditions
- Wound, Infection Prevention, Negative Pressure Wound Therapy
- Being tested
- Negative Pressure Wound Therapy, Standard Antibiotic Treatment
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound TherapyOther
Negative Pressure Wound Therapy is an intervention in which a suction is applied at applied thus creating a negative pressure which not only removes any exudate but also aids in formation of granulation tissue. NPWT is provided along with empirical prophylactic antibiotics
Standard Antibiotic TreatmentDrug
According to hospital antibiogram, empirical antibiotics are given prophylactically
| Study group | Role | What they receive |
|---|---|---|
| Participants with Negative Pressure Wound Therapy | Experimental | In group A, Negative Pressure Wound Therapy will be applied at end of laparotomy. Participants will be shifted to post-surgical wad for 72 hours and then will be discharged with prescription of standard antibiotics course. Patients will be followed-up in OPD for 30 days and will be assessed in terms of surgical site infection and re operation. Receives: Other: Negative Pressure Wound Therapy; Drug: Standard Antibiotic Treatment |
| Participants without Negative Pressure Wound Therapy | Experimental | In group B, Negative Pressure Wound Therapy will be applied at end of laparotomy. Participants will be shifted to post-surgical wad for 72 hours and then will be discharged with prescription of standard antibiotics course. Patients will be followed-up in OPD for 30 days and will be assessed in terms of surgical site infection and re operation. Receives: Drug: Standard Antibiotic Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection
It will be labelled if there will be presence of pus and pus discharge from wound site, confirmation of presence of pathogen through culture along with presence of pain, swelling, tenderness at wound site on physical examination during 15-30 days of surgery.
Measured: 03 Months
Secondary outcomes (1)
Re Operation
It will be labelled if patient will undergo surgery due to severe surgical site wound infection that develop during 15-30 days of surgery and not healed with antibiotics course.
Measured: 03 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start25 Mar 2025
- Primary completion25 Jun 2025 (estimated)
- Study completion25 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Hamail Khanum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Hamail Khanum, Gulab Devi Hospital
- Investigators
- Professor Dr Maratab Ali, MBBS FCPS, Study director, Gulab Devi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957964
- Sponsor's protocol ID
- 280
- Status last verified
- Apr 2025
- First submitted
- 27 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Negative Pressure Wound Therapy in Laparotomy Wounds: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06957964
- Acronym / sponsor ID
- 280
- Conditions
- Wound, Infection Prevention, Negative Pressure Wound Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Dr Hamail KhanumUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 25 Jun 2025 (estimated)
- Study completion
- 25 Jun 2025 (estimated)
- First posted
- 6 May 2025 (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.
Total 70 participants meeting selection criteria will be enrolled in the study from operational theatre. They will be randomly divided in two groups by using lottery method. In group A, Negative Pressure Wound Therapy will be applied at end of procedure. In group B, no Negative Pressure Wound Therapy will be placed. They will be shifted to post-surgical wad for 72 hours and then will be discharged with prescription of standard antibiotics and will be followed-up in OPD for 30 days. If patient will develop surgical site wound infection, then it will be noted. If infection will not be cured with antibiotics course, then re-operation will be done. Patients complications will be managed as per hospital protocol. All this information will be recorded in proforma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Negative Pressure Wound Therapy | Experimental | Other: Negative Pressure Wound Therapy, Drug: Standard Antibiotic TreatmentIn group A, Negative Pressure Wound Therapy will be applied at end of laparotomy. Participants will be shifted to post-surgical wad for 72 hours and then will be discharged with prescription of standard antibiotics course. Patients will be followed-up in OPD for 30 days and will be assessed in terms of surgical site infection and re operation. |
| Participants without Negative Pressure Wound Therapy | Experimental | Drug: Standard Antibiotic TreatmentIn group B, Negative Pressure Wound Therapy will be applied at end of laparotomy. Participants will be shifted to post-surgical wad for 72 hours and then will be discharged with prescription of standard antibiotics course. Patients will be followed-up in OPD for 30 days and will be assessed in terms of surgical site infection and re operation. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of age between 20 to 70 years, both genders
- Undergoing laparotomy under general anaesthesia
- ASA I-II
Key exclusion criteria (3 listed)
- Patients who did not complete the follow up instructions
- Pregnant patients
- Patients already undergone a relook laparotomy, if their abdomen is left open or if unable to adhere
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 TherapyNegative Pressure Wound Therapy is an intervention in which a suction is applied at applied thus creating a negative pressure which not only removes any exudate but also aids in formation of granulation tissue. NPWT is provided along with empirical prophylactic antibiotics | Other | Participants with Negative Pressure Wound Therapy |
| Standard Antibiotic TreatmentAccording to hospital antibiogram, empirical antibiotics are given prophylactically | Drug | Participants with Negative Pressure Wound Therapy, Participants without Negative Pressure Wound Therapy |
Primary outcome
Surgical Site Infection
Time frame: 03 Months
It will be labelled if there will be presence of pus and pus discharge from wound site, confirmation of presence of pathogen through culture along with presence of pain, swelling, tenderness at wound site on physical examination during 15-30 days of surgery.
1 secondary outcome
Re Operation
Time frame: 03 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: No
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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.
Professor Dr Maratab Ali, MBBS FCPS study director
Gulab Devi Hospital
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 and Standard Antibiotic Treatment in people with Wound and Infection Prevention, run by Dr Hamail Khanum 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 6 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Hamail Khanum, MBBS (+923235511997, hamailkhanum@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection (time frame: 03 Months). 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 6 May 2025; AzTrials last refreshed its copy on 26 Oct 2026.