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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02071251
Enrollment
105
Registered
2014-02-25
Start date
2011-12-31
Completion date
2013-07-31
Last updated
2015-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound Complications, Wound Infection, Wound Separation

Keywords

Wound complications, Wound infection, Wound separation

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.

Interventions

PROCEDUREProspective 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.

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 89 Years
Healthy volunteers
No

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. -

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.

Design outcomes

Primary

MeasureTime frameDescription
Wound complicationWithin 8 weeks of surgeryThe 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

MeasureTime frameDescription
Wound separation8 weeks of surgeryWound separation within 8 weeks of surgery
Wound infection8 weeks of surgeryWound infection within 8 weeks of surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026