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

NCT06957964 | Recruiting

• 1 other identifier: 280
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound; Infection Prevention; Negative Pressure Wound Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  03 Months

Secondary Outcomes (1)

• Re Operation

  03 Months

Study Arms (2)

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.

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.

Drug: Standard Antibiotic Treatment

Interventions

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

Participants with Negative Pressure Wound Therapy

Standard Antibiotic Treatment DRUG

According to hospital antibiogram, empirical antibiotics are given prophylactically

Participants with Negative Pressure Wound Therapy; Participants without Negative Pressure Wound Therapy

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Hamail Khanum: lead

Study Sites (1)

Gulab Devi Hospital Lahore

Lahore, Punjab Province, 05307, Pakistan

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Professor Dr Maratab Ali, MBBS FCPS

  Gulab Devi Hospital

  STUDY DIRECTOR

Central Study Contacts

Dr Hamail Khanum, MBBS

CONTACT

+923235511997; hamailkhanum@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Department Surgery

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: May 6, 2025
• Study Start: March 25, 2025
• Primary Completion: June 25, 2025
• Study Completion: June 25, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)