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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06957964
Enrollment
70
Registered
2025-05-06
Start date
2025-03-25
Completion date
2025-06-25
Last updated
2025-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound, Infection Prevention, Negative Pressure Wound Therapy

Brief 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. 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

OTHERNegative 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

According to hospital antibiogram, empirical antibiotics are given prophylactically

Sponsors

Dr Hamail Khanum
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Surgical Site Infection03 MonthsIt 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.

Secondary

MeasureTime frameDescription
Re Operation03 MonthsIt 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.

Countries

Pakistan

Contacts

Primary ContactDr Hamail Khanum, MBBS
hamailkhanum@gmail.com+923235511997

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026