Effectiveness of cyanoacrylate microbial sealant in the reduction of surgical site infection in gynecologic oncology procedures: A phase III single institution prospective randomized trial.
OBJECTIVE
Surgery is a cornerstone for patients with gynecologic malignancies. Surgical site infections (SSI) remain a source of post-operative morbidity. Consequences range from escalated costs, delay in adjuvant therapy, and increased morbidity. Our primary objective was to evaluate the effectiveness of a cyanoacrylate microbial sealant (CMS) to reduce post-operative SSI following laparotomy for suspected gynecologic malignancy.


METHODS
Patients were randomized using a 1:1 allocation to receive either standard skin preparation or standard preparation with CMS and stratified by BMI. Patients were followed for 6weeks for SSI. Demographic data was collected through the EMR. Associations between SSI, use of CMS, and clinicopathologic factors were explored using descriptive statistics, chi-square and multivariate analysis.


RESULTS
300 patients underwent randomization. Median age of the cohort was 58. Arms were matched and there was no difference in rate of medical comorbidities. Mean BMI was 38.8kg/m2in patients randomized to BMI≥30 and 26.3kg/m2randomized to BMI<30. Surgical characteristics for the entire cohort: 66% malignancy, 91% clean-contaminated, 21% bowel surgery, 25% transfusion. Seventy-six (25%) patients developed a SSI: 43 patients (28%) treated with CMS, compared to 33 (21%) patients treated without CMS (p=0.18). Multivariate model demonstrated that BMI≥30 (p<0.005), surgery for malignancy (p=0.010), transfusion in the OR (p<0.001), and closure with staples (p=0.0005) were associated with post-operative SSI.


CONCLUSIONS
Patients presenting to a gynecologic oncologist for surgery frequently present with multiple risk factors for SSI and laparotomy is complicated by surgical-site complications in up to 30% of cases. The addition of CMS alone does not appear to reduce risk of overall SSI. Additional risk-reducing strategies including use of antimicrobial agents and optimization of modifiable risk factors prior to surgery should be explored as pathways for reducing this significant post-operative morbidity.
Stephenson Oklahoma Cancer Center, Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Oklahoma, United States. Electronic address: eric.thomas8082@gmail.com.
Eric D
ED
Thomas
Stephenson Oklahoma Cancer Center, Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Oklahoma, United States.
Elizabeth K
EK
Nugent
University of Oklahoma Health Sciences Center, School of Medicine, United States.
Matthew C
MC
MacAllister
Stephenson Oklahoma Cancer Center, Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Oklahoma, United States.
Katherine M
KM
Moxley
Stephenson Oklahoma Cancer Center, Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Oklahoma, United States.
Lisa
L
Landrum
Stephenson Oklahoma Cancer Center, Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Oklahoma, United States.
Joan
J
L Walker
Stephenson Oklahoma Cancer Center, Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Oklahoma, United States.
D S
DS
McMeekin
Stephenson Oklahoma Cancer Center, Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Oklahoma, United States.
Robert S
RS
Mannel
University of Alabama at Birmingham, Birmingham, AL, United States.
Gerald
G
McGwin
Stephenson Oklahoma Cancer Center, Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Oklahoma, United States.
Kathleen N
KN
Moore
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use; D002710:Chlorhexidine / Q000627:therapeutic use; D003487:Cyanoacrylates / Q000627:therapeutic use*; D005260:Female; D005833:Genital Neoplasms, Female / Q000601:surgery*; D006801:Humans; D008875:Middle Aged; D011300:Preoperative Care; D011446:Prospective Studies; D012307:Risk Factors; D013530:Surgical Wound Infection / Q000517:prevention & control* / Q000628:therapy; D055815:Young Adult
D000900:Anti-Bacterial Agents; D000891:Anti-Infective Agents, Local; D003487:Cyanoacrylates; D002710:Chlorhexidine
Antimicrobial sealants; Laparotomy for gynecologic malignancy; Surgical site infection