Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery

Dallas VA Medical Center

Status: Completed

Conditions: Surgical Wound Infections; Colorectal Surgery

Treatments: Procedure: standard operating management

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00953784

07-025 (Other Identifier)

Details and patient eligibility

About

This is a comparison, at this VA Hospital, of standard operating room management in colorectal surgery to a more rigid management using an additional five previously tested treatments to determine if this changes the rate of post operative wound infections.

Full description

A comparison between standard operating room:

1. use of pre-op bowel prep (Golytely or Phosphosoda,plus 3 doses of oral antibiotics(Erythromycin and Neomycin), and fleets enema the day before surgery
2. Standard anesthesia FiO2 (approx. 30-50%)during surgery
3. Standard IV fluids during surgery(greater than 200cc per hour)
4. Standard post-op O2 by mask for 2 hours

To extended operating room procedures of:

1. No po antibiotics or pre-op bowel prep other than enema prior to surgery
2. Skin warming at least 15 minutes prior to and during surgery(core temp 36C+)
3. IOBAN drapes and Plastic wound protectors used during surgery
4. Restricted IV fluids less than 200cc per hour during surgery
5. Increased FiO2 to 80% during surgery and 2 hours after by mask

Monitoring for post-op wound infections at discharge and up to 30days post-op

Enrollment: 197 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled VA adult elective colorectal surgery patient

Exclusion criteria

• Non VA adults, emergent colorectal surgery, scheduled multiple surgery procedures,pts with other infections being treated

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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197 participants in 2 patient groups

1

No Intervention group

Description:

Standard management

2

Active Comparator group

Description:

Extended management: with no bowel prep except enema,restricted fluids, increased O2,body warming and use of skin protectors during surgery as previously described

Treatment:

Procedure: standard operating management