Surgical Site Infection
Conditions
Keywords
Surgical site infection, Skin preparation, Cost analysis
Brief summary
The purpose if this study is to determine whether a microbial sealant (iodine + cyanoacrylate) \[InteguSEAL®, Kimberly-Clark\] reduces surgical site infections when compared to iodine and isopropyl alcohol (povacrylex in isopropyl alcohol) \[Duraprep®\] in oncologic surgery.
Detailed description
Patient's skin flora is a major source of pathogens, and microbial contamination of the surgical site is a likely precursor of SSI. A variety of skin products may be used, including iodophors, alcohol-containing products, and clorhexidine gluconate. Despite these perioperative tactics, bacteria continue to survive at the skin level and migrate to contaminate the wound. A microbial sealant (InteguSEAL®, Kimberly-Clark) that uses cyanoacrylate to seal endogenous skin flora has demonstrated to reduce wound contamination. The efficacy of the microbial sealant in preventing SSI has been tested in cardiovascular surgery and open inguinal hernia repair, with a reduction on SSI rate when compared to standard skin preparations. This cyanoacrylate has not been tested in oncologic surgeries.
Interventions
DEVICE2-octyl cyanoacrylate [InteguSEAL®]
At operating room arrival prior to surgery, povidone-iodine is applied on the skin surface on concentric circles as recommended; after drying, the cyanoacrylate device is opened and a layer of the sealant is applied on the incision and skin site(IS100 for patients undergoing mastectomy, and IS200 for patients undergoing gynecologic or digestive tract surgeries).
DEVICEIodine povacrylex in isopropyl alcohol [Duraprep®, 3M]
At the operating room arrival a few minutes before the incision, cleansing and skin antisepsis is done with the prefilled device with iodine povacrylex in isopropyl alcohol as recommended by 3M.
Sponsors
Kimberly-Clark de México
National Institute of Cancerología
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \>= 18 years undergoing elective clean or clean-contaminated breast, gynecologic or digestive tract surgery * Accepts to participate and signs the informed consent form * Have a telephone number to be contacted after surgery
Exclusion criteria
* Previous allergy to one of the study products * Two or more procedures in different anatomical sites at the same time / surgery (v.g. hysterectomy and mastectomy) * Pregnancy * Breast feeding * Contaminated or infected surgeries
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infection | 30-45 days | Patients we'll be followed prospectively by direct observation to evaluate if a surgical infection occurs. After 30 days of follow-up, patients will be classified as having or not a surgical site infection using the CDC criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost analysis | 30-45 days | We'll be doing a cost-efectiveness analysis at the end of the study considering the treatment arm, complications developed from surgery to end of follow-up and costs for its treatment. |
Countries
Mexico
Contacts
Primary ContactDiana Vilar-Compte, MD, MsC
Outcome results
None listed