Prophylactic Negative Pressure Wound Therapy in Laparotomy Wounds: A Randomized Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Negative Pressure Wound Therapy, Standard Antibiotic Treatment.
- Who it may be relevant to
- Registry conditions: Wound, Infection Prevention, Negative Pressure Wound Therapy. Basic parameters: 20 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- Surgical Site Infection [Time frame: 03 Months]
Secondary outcome measures (1)
- Re Operation [Time frame: 03 Months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Gulab Devi Hospital Lahore — Lahore
Identifiers
NCT: NCT06957964 · 280