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Irrigation and Suction Trial to Prevent SSI

NCT05611944 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2022-11-15

No results posted yet for this study

Summary

The study will be conducted on women with risk factors for SSI assigned to gynecological surgery with an open abdominal approach. The participants will be designated to either Irrigation and suction arm by bilateral drain insertion or the control arm by randomization through the parallel assignment. The participants will be followed for the outcome for four days in the hospital and then at 4 weeks, 8 weeks and 12 weeks postoperatively. The primary outcome measure will be the SSI rate. Secondary outcomes will be signs of SSI, post-operative pain, other complications and patient satisfaction.

Conditions

  • Surgical Site Infection
  • Diabete Mellitus
  • Abdominal Hysterectomy

Interventions

DEVICE

Irrigation and suction through subcutaneus drains

Irrigation of wound will done by attaching 500cc saline to the drain on one side and let it flow freely from the other drain followed by suction of wound by attaching 60cc suction syringes on both sides creating suction pressure for 100 cc fluid.

Sponsors & Collaborators

  • King Edward Medical University

    lead OTHER

Principal Investigators

  • Mohammmad Khalid, MBBS,MHM · Pakistan Institute of Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
41 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2021-12-31
Completion
2022-03-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05611944 on ClinicalTrials.gov