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

NCT ID: NCT06957964

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-25

Study Completion Date

2025-06-25

Brief Summary

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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.

Detailed Description

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Conditions

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Wound Infection Prevention Negative Pressure Wound Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Negative Pressure Wound Therapy

Intervention Type 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

Intervention Type DRUG

According to hospital antibiogram, empirical antibiotics are given prophylactically

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.

Group Type EXPERIMENTAL

Standard Antibiotic Treatment

Intervention Type DRUG

According to hospital antibiogram, empirical antibiotics are given prophylactically

Interventions

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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

Intervention Type OTHER

Standard Antibiotic Treatment

According to hospital antibiogram, empirical antibiotics are given prophylactically

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr Hamail Khanum

OTHER

Sponsor Role lead

Responsible Party

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Dr Hamail Khanum

Head of Department Surgery

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Professor Dr Maratab Ali, MBBS FCPS

Role: STUDY_DIRECTOR

Gulab Devi Hospital

Locations

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Gulab Devi Hospital Lahore

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Dr Hamail Khanum, MBBS

Role: CONTACT

+923235511997

Facility Contacts

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Prof Dr Maratab Ali, MBBS, FCPS

Role: primary

Other Identifiers

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280

Identifier Type: -

Identifier Source: org_study_id

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