Comparative Study on the effect of change of Sterile Surgical gloves before wound closure on the rate of Surgical Site Infections in patients undergoing Emergency Abdominal Exploratory laparotomy in the setup of a Tertiary care center; A Prospective study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Government Medical College
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- To study whether a change in gloves before wound closure helps prevent SSIs in patients undergoing Emergency Exploratory laparotomy.
Study Overview
Brief Summary
1) Surgical site infections (SSI) are among the most common hospital-acquired infections in patientsundergoing Emergency Abdominal exploratory surgeries for Bowel perforations,obstructions, etc.
2) In recent years SSIs areaccounting for 36.4% of infections reported to the Centers for Disease Control.1 Consistent with the NHSN,abdominal surgeries are the foremost common reason for SSIs accounting for nearly50%.2
3) SSI manifests as induration andredness of the incision site to discharge from the wound which could be of any nature from serous discharge to frankpus. This can lead to problems ranging from superficial wound gape to complete dehiscence of theabdominal wall at the site of wound closure. Depending on the grade of wound infection, it can lead to aconsiderable financial strain on the health care facilities as well as on the patient owing to their prolonged hospitalstay, secondary dressing cost, readmission, loss of employment & disability.3
4) A retrospective review ofhospital records by Wick et al. documented 30- and 90-day readmission rates for SSIs after CRS of 11.4 and23.3% respectively, with amedian cost per event of $8885USD.4
5) A perioperative mortalityrate for SSI of 3 percent has been reported, with 75 percent of associateddeaths directly attributable to the SSI,5 its estimated that 60% ofthose outcomes may be prevented with the increased use of evidence-based measures.6
6) Studies show that the implementation of a five-partbundle consisting of antibioticprophylaxis, hair removal before surgery, perioperative normothermia, perioperative euglycemia, and operating room discipline has decreased the incidence of SSI from 22% to 11%.7
7) Following all additives of theBundle is challenging to comply with in an Emergency setting, subsequently raising the question of whether or not analternate of change of gloves before skin closure, being a far more feasible factor to comply with, canlower the incidence of SSI and improve patients outcome.
8) Abundant data have been obtained in the field of gynecology, urology & electivesurgeries but the information about surgical site infection inEmergency abdominal surgeries seems tobe lacking.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Double Blind Double Dummy
Eligibility Criteria
- Ages
- 12.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •consented for the study
- •Patient undergoing Emergency abdominal Exploratory laparotomy through midline vertical incision for abdominal pathology.
Exclusion Criteria
- •i)Patients posted for elective/planned operations.
- •ii)Patients undergoing re-exploratory procedures.
- •iii)Immunocompromised individuals.
- •iv)Rest any other procedure in an Emergency setting that is done without a midline vertical incision.
Outcomes
Primary Outcomes
To study whether a change in gloves before wound closure helps prevent SSIs in patients undergoing Emergency Exploratory laparotomy.
Time Frame: 2 weeks
Secondary Outcomes
- ) To Identify the rate of SSI in emergency laparotomy procedures.(2 weeks)
- 2)To Compare rates of SSI in Case & control arm.(2 weeks)
- 3)To study the Effect of change of gloves before wound closure on rates of SSI.(2 weeks)