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NCT Number: NCT06957964

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

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.

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Key information

Conditions

Wound Infection Prevention Negative Pressure Wound Therapy Wounds and Injuries

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gulab Devi Hospital Lahore

Lahore, Punjab Province, 05307, Pakistan

Location status: Recruiting

Location contact

Prof Dr Maratab Ali, MBBS, FCPS

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Negative Pressure Wound Therapy

Other

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 Treatment

Drug

According to hospital antibiogram, empirical antibiotics are given prophylactically

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Hamail Khanum, MBBS

CONTACT

[email protected]

+923235511997

Sponsors and collaborators

Lead sponsor

Dr Hamail Khanum

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 6, 2025
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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