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

NCT ID: NCT02071251

Last Updated: 2015-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-07-31

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.

Conditions

Wound Complications; Wound Infection; Wound Separation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prospective intervention

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.

Group Type: EXPERIMENTAL

Prospective wound complication protocol

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Akiva P Novetsky, MD, MS

Role: STUDY_DIRECTOR

Washington University School of Medicine

Locations

Washington University School of Medicine and Barnes Jewish Hospital

St Louis, Missouri, United States

Countries

United States

References

Bratzler DW, Houck PM; Surgical Infection Prevention Guideline Writers Workgroup. Antimicrobial prophylaxis for surgery: an advisory statement from the National Surgical Infection Prevention Project. Am J Surg. 2005 Apr;189(4):395-404. doi: 10.1016/j.amjsurg.2005.01.015.

Reference Type: BACKGROUND

PMID: 15820449 (View on PubMed)

Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988.

Reference Type: BACKGROUND

PMID: 20054046 (View on PubMed)

Other Identifiers

201108303

Identifier Type: -

Identifier Source: org_study_id