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

Dr Hamail Khanum

Status: Enrolling

Conditions: Infection Prevention; Negative Pressure Wound Therapy; Wound

Treatments: Drug: Standard Antibiotic Treatment; Other: Negative Pressure Wound Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06957964

280

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

70 participants in 2 patient groups

Participants with Negative Pressure Wound Therapy

Experimental group

Description:

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.

Treatment:

Other: Negative Pressure Wound Therapy

Drug: Standard Antibiotic Treatment

Participants without Negative Pressure Wound Therapy

Experimental group

Description:

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.

Treatment:

Drug: Standard Antibiotic Treatment