Outcomes of High-volume Saline Irrigation VS Povidone-Iodine Solution Cleaning of IOWI in Preventing SSIs in Emergency Laparotomies

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorDow University of Health Sciences

About this trial

The goal of this clinical trial is to compare the outcomes of High-volume saline irrigation vs Povidone-iodine solution cleaning of the intraoperative incision wound in preventing superficial surgical site infections in patients undergoing emergency laparotomies. The main question it aims to answer are:

* Incidence of SSI after intervention * Length of hospital stay

Participants will be randomly assigned to two groups receiving either of the two groups:

Group A: 1000ml of IOWI with saline solution prior to incision closure Group B: The incisional wound will be closed conventionally without irrigation.

Researchers will compare groups A( experimental group) and B (control group) to compare the incidence of superficial surgical site infections after intervention.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Patients undergoing emergency laparotomy under the care of surgical-6 unit of Dr. Ruth K. M. Pfau Civil Hospital Karachi

The age of patients should be between 18-60 years old.

Disqualifiers

Diabetic patients

Immune-suppressed patients

Patients taking steroids

Patients undergoing chemo-radiotherapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 0.9% saline solution

    Procedure/Surgery

    During emergency laparotomy, after the primary surgical procedure. the sheath will be sutured and the incision site will then be irrigated with three rounds of 1 liter of 0.9% saline solution, which will be completely aspirated before the closure of the incisional wound in experimental group.

  • Povidone-iodine Swab

    Procedure/Surgery

    No intra-operative wound lavage done, and wound would be cleaned with povidone doused swab.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Superficial Surgical site infections

Development of Superficial Surgical Site Infection as determined by the CDC guidelines.

Time frame
Upto 4 weeks post-operatively

Secondary outcomes

1

Length of Hospital Stay

Number of in-hospital days (from time of admission to time of discharge)

Time frame
Upto 4 weeks post-operatively

Other outcomes

Sponsors and contacts

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