Prophylactic Negative Pressure Wound Therapy in Laparotomy Wounds: A Randomized Clinical Trial

April 27, 2025 updated by: Dr Hamail Khanum
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 05307
        • Recruiting
        • Gulab devi Hospital Lahore
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients of age between 20 to 70 years, both genders
  • Undergoing laparotomy under general anaesthesia
  • ASA I-II

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants with Negative Pressure Wound Therapy
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.
Other: Negative Pressure Wound Therapy
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
Drug: Standard Antibiotic Treatment
According to hospital antibiogram, empirical antibiotics are given prophylactically
Experimental: Participants without Negative Pressure Wound Therapy
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.
Drug: Standard Antibiotic Treatment
According to hospital antibiogram, empirical antibiotics are given prophylactically

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
03 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Re Operation
Time Frame: 03 Months
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.
03 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Hamail Khanum

Investigators

  • Study Director: Professor Dr Maratab Ali, MBBS FCPS, Gulab devi Hospital Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2025

Primary Completion (Estimated)

June 25, 2025

Study Completion (Estimated)

June 25, 2025

Study Registration Dates

First Submitted

April 27, 2025

First Submitted That Met QC Criteria

April 27, 2025

First Posted (Actual)

May 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2025

Last Update Submitted That Met QC Criteria

April 27, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 280

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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