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Published on: November 4, 2010
Microbial sealants do not decrease surgical site infection for clean-contaminated colorectal procedures
1Keck School of Medicine of USC, 1441 Eastlake Ave, Suite 7418, Los Angeles, CA, 90033, USA, mikedoorly@gmail.com.
Background:
Surgical site infections (SSI) are costly complications that may cause significant morbidity and increase the cost of care, particularly in colorectal surgery. Microbial sealants (MS) are a new class of wound barriers aimed at decreasing SSI; however, there is only evidence of benefit in clean class 1 procedures. Based on its success in class 1 procedures, we hypothesized that a microbial sealant could reduce the rate of SSI by half for clean-contaminated colorectal procedures (class 2).
Methods:
This was a single institution, multihospital, prospective, randomized study approved by the institutional review board. The primary objective was to determine the rate of SSI when microbial sealant (InteguSeal© Kimberly-Clark) is used compared to control (no microbial sealant). Data collected included: open versus laparoscopy, age, body mass index (BMI), diabetes and morbidity [American Society of Anesthesiologists (ASA) class], hospital readmission, reoperation and wound dehiscence. Enrolled subjects received the same preoperative mechanical bowel preparation with oral antibiotics, operative skin preparation (Chloraprep), Surgical Care Improvement Project guidelines implementation), and postoperative care glycemic control for diabetics.
Results:
A total of 100 subjects were recruited over 15 months (MS-50; no MS-50). The overall incidence of SSI was 12 %, 14 % (7/50) in the MS versus 10 % (5/50) in the no MS group (p = 0.545). SSI incidence with and without microbial sealant was not significantly different in either the open or the laparoscopic subgroup. Laparoscopy decreased absolute risk of SSI by 16 %. Secondary data (age, BMI, diabetes, ASA) and tertiary data (readmission, reoperation, wound dehiscence) were positively correlated with SSI.
Conclusions:
Microbial sealant as employed in this study did not appear to offer any benefit in a class 2 (clean contaminated) operative procedure when perioperative care is standardized. The relative benefit of laparoscopy was also confirmed but unaffected by use of the microbial sealant.
Insights
Microbial sealant did not reduce surgical site infections (SSI) in clean-contaminated colorectal surgery. Standardized perioperative care limited the sealant's benefit, though laparoscopy showed a reduced SSI risk.
Area of Science:
- Colorectal Surgery
- Infectious Disease
- Surgical Innovation
Background:
- Surgical site infections (SSI) are a significant concern in colorectal surgery, increasing morbidity and healthcare costs.
- Microbial sealants (MS) are emerging wound barriers, with proven efficacy in clean (class 1) procedures.
- This study investigated MS efficacy in clean-contaminated (class 2) colorectal procedures.
Purpose of the Study:
- To evaluate the effectiveness of microbial sealant in reducing SSI rates in class 2 colorectal surgery.
- To compare SSI incidence between patients receiving microbial sealant and a control group.
- To explore the impact of surgical approach (open vs. laparoscopy) and patient factors on SSI rates.
Main Methods:
- A prospective, randomized, single-institution study involving 100 patients undergoing colorectal surgery.
- Patients were randomized to receive either microbial sealant (InteguSeal©) or no sealant.
- Standardized perioperative care, including bowel preparation, skin antisepsis, and glycemic control, was applied to all participants.
Main Results:
- The overall SSI incidence was 14% in the microbial sealant group and 10% in the control group (p=0.545), showing no significant difference.
- SSI rates did not differ significantly between groups in open or laparoscopic subgroups.
- Laparoscopy was associated with a 16% absolute risk reduction in SSI, independent of sealant use. Patient factors like age, BMI, and diabetes were correlated with SSI.
Conclusions:
- Microbial sealant did not demonstrate a significant benefit in reducing SSI for class 2 colorectal procedures when standardized perioperative care was implemented.
- The study confirmed the benefit of laparoscopy in reducing SSI risk.
- Further research may be needed to identify specific patient populations or surgical conditions where microbial sealants could offer a benefit.
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