Anal Occlusion and SSI Reduction

Overview

About this study

The purpose of this study is to create a special preparation protocol for the vaginal and perineal area that would include an occlusive dressing over the anal orifice (Anal Occlusive Dressing-AOD). We do hypothesize that it would eliminate or significantly reduce cross contamination of the bowel content with the surgical site and hence reduce the risk of SSI.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Patients subject to a laparoscopic hysterectomy procedure necessitating uterine manipulator use,
Age 18-65.

Exclusion Criteria:

Patient known to have a vesicovaginal or rectovaginal fistula.
Patients who have a documented tape allergy.
Patients know to have an active pelvic infection.
Patient diagnosed or known to have fecal incontinence.
Patients diagnosed or known to have severe external hemorrhoids.
Patients with a very short perineal body with < 2cm.
Patients who were found to have a disruption in the occlusive dressing seal at the end of the case (blood soilage).
Patients necessitating a rectal exam or manipulation as part of the procedure.
Patient with visible skin irritation or inflammation around the anal orifice.

Eligibility last updated 2/14/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Mankato, Minn. Mayo Clinic principal investigator Tarek Khalife, M.D.	Closed for enrollment	Contact information: Tarek Khalife M.D. (507) 594-4700 Khalife.Tarek@mayo.edu

Mayo Clinic Location

Status

Contact

Mankato, Minn.

Mayo Clinic principal investigator

Tarek Khalife, M.D.

Closed for enrollment

Contact information:

Tarek Khalife M.D.

(507) 594-4700

Khalife.Tarek@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials