A Study to Evaluate a Quality Improvement Intervention to Reduce Wound Separation Rates in Obese Gynecologic Oncology Service Patients Undergoing Abdominal Surgery

Phase 2

Completed

• Conditions: Wound Infection; Wound Complications; Wound Separation
• Interventions: Procedure: Prospective wound complication protocol

• Registration Number: NCT02071251
• Lead Sponsor: Washington University School of Medicine

Brief Summary

Approximately 500,000 surgical site infections occur annually in the US. These lead to worse patient quality of life, more outpatient and emergency room visits, readmissions and home services, with an estimated increase in costs of at least $3500 per complication. Surgical site infections are associated with increasing body mass index. There is limited and conflicting data of the utility of multiple surgical interventions to decrease the risk of surgical site complications. The investigators explored the effect of a prospective care pathway for closure of vertical abdominal wounds on patient's wound complications.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Study First Submitted: 2014-02-22
• Study First Submitted QC: 2014-02-22
• Study First Posted: 2014-02-25
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-22
• Last Update Posted: 2015-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

Inclusion Criteria

Women were eligible if they were between the ages of 18-89, with a BMI ≥ 30 kg/m2 undergoing a gynecologic procedure via a vertical abdominal incision. -

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Exclusion Criteria

Planned laparoscopic surgery, planned panniculectomy or other plastic surgery procedure at the time of laparotomy, prior history of hernia repair with mesh or planned mesh hernia repair at the current procedure, enterotomy or intestinal surgery, a history of prior radiation to the abdomen or pelvis, concurrent pregnancy, current incarceration, or inability to provide informed consent, including inability to understand spoken English.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prospective intervention	Prospective wound complication protocol	The skin and subcutaneous tissues were incised using a scalpel or cutting electrocautery. Use of coagulation current on the skin or subcutaneous tissues was not allowed, except focally to attain hemostasis. At the conclusion of surgery, a 7mm Jackson-Pratt drain was placed below Camper's fascia, which in turn was closed with 3-0 plain catgut suture. The skin was closed with staples. Dressings were retained for at least twenty-four hours. Staples were to be retained for at least two weeks.

Primary Outcome Measures

Name	Time	Method
Wound complication	Within 8 weeks of surgery	The primary outcome for our study was a wound complication within eight weeks of laparotomy. Wound complication was defined as seroma, hematoma, separation, or infection requiring additional medical and/or surgical management within eight weeks of laparotomy.

Secondary Outcome Measures

Name	Time	Method
Wound separation	8 weeks of surgery	Wound separation within 8 weeks of surgery
Wound infection	8 weeks of surgery	Wound infection within 8 weeks of surgery

Trial Locations

Locations (1)

Washington University School of Medicine and Barnes Jewish Hospital; 🇺🇸 St Louis, Missouri, United States