Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04401553 |
| Other study ID # |
STU-2020-0317 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
August 16, 2024 |
| Est. completion date |
August 2026 |
Study information
| Verified date |
December 2023 |
| Source |
University of Texas Southwestern Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Postoperative surgical site infection (SSI) is associated with unnecessary use of heath care
resources including prolonged hospitalization and increased hospital readmission.
Perioperative antibiotic prophylaxis is one of the most important strategies for prevention
of SSI. If there is a beta-lactam allergy, second tier antibiotics (vancomycin and
clindamycin) are recommended alternatives to first- and second-generation cephalosporins
because of fears of possible allergy.
This prospective, randomized, and single-blinded clinical trial is designed to examine
causality between second tier antibiotics use and surgical site infections in the subjects
with a documented unverified penicillin allergy. Unverified beta-lactam allergy could be
associated with antimicrobial treatment failure with second tires antibiotics during
postoperative period.
Description:
In this prospective, randomized, single-blinded clinical trial, eligible subjects will be
identified based on scheduled elective hysterectomy. Subjects with documented beta-lactam
allergy in their chart will be evaluated to differentiate true allergy and allergy-like
events. Subjects with history of allergy-like event to beta-lactam antibiotics will be
randomized to either receive first tier antibiotic or second tier antibiotics before
anesthesia induction.
Preoperative Screening of Allergy The potential subjects' history of allergy will be reviewed
according to described criteria of allergy like events. Subjects with documented anaphylaxis
to first tier and second tier antibiotics will be excluded. Only subjects with a history of
previous allergic-like event after beta-lactam antibiotic will be enrolled to the study.
An allergy self-screening questionnaires will be reviewed before the surgery to identify true
allergy or allergy-like event to beta-lactam (penicillin). Allergic-like events include
nausea, vomiting, feeling dizziness, dermatitis seen after beta-lactam antibiotic, or any
other description of hypersensitivity reactions other than anaphylactic shock, angioedema,
laryngeal spasm, and shock. Administration of the potential confounding drugs such as
antihistamines, systemic and topical corticosteroids and potential confounding diagnosis such
as autoimmune disease will be also reviewed together with allergy history of the subjects to
differentiate true hypersensitivity and allergy-like events to penicillin and other
beta-lactam antibiotics.
Postoperative Follow-up for SSI:
Subjects will be followed postoperatively for post-discharge SSIs or clostridium infection by
reviewing medical records and contacting via phone and survey. If the subject received care
outside the clinic, their provider will be contacted to obtain outside clinic record with
subject permission.
The post-discharge SSIs will be followed according to the SSI surveillance survey protocol
(Harrington et al. 2013). A combination of methods listed below will be used to detect
post-discharge SSI.
1. Identification of subject readmitted with SSI (medical record review)
2. Detection of SSI at outpatient clinic, other return visit to hospital or review by
healthcare staff (direct observation of the wound by health professional)
3. Telephone interviews or questionnaire (self-reported SSI)
- Early post-operative follow-up (30-days) Subjects will be contacted via phone at 30
days (±3 days) post-operatively to determine if they have been told by a physician
they have a wound infection or if their post-operative antibiotics will extend due
to concern for wound infection.
- Late post-operative follow-up (90-days) A redcap survey will be sent at
postoperative 90 days to review any possible wound infection.
Surgical Site infection (Wound) Classification Based on standard definitions from the US
Centers for Disease Control and Prevention for SSI, the wound infections will be classified
as
1. superficial incisional (infection occurred within 30 days after any operative procedure
and involved only skin and subcutaneous tissue of the incision),
2. deep incisional primary/secondary (infection occurred within 31-90 days after the
operative procedure and involved deep soft tissues of the incision), or organ/space
(infection occurred within 31-90 days after the operative procedure and involved any
part of the body deeper than the fascia/muscle layers that was opened or manipulated
during the operative procedure.
Criteria of the SSI decision for the female reproductive tract infection (excluding
endometritis or vaginal cuff infections) must meet at least one of the following criteria:
- Criterion 1: Organisms are cultured from tissue or fluid from affected site.
- Criterion 2: There is an abscess or other evidence of infection of affected site seen
during a surgical operation or histopathological examination.
- Criterion 3: The subjects have two of the following signs or symptoms with no other
recognized cause: fever (>38°C), nausea, vomiting, pain, tenderness, or dysuria, and at
least one of the following: (a) organisms cultured from blood (b) diagnosis by
physician.
The SSI criteria listed above will be applied to the self-reported SSI. Type of SSI will not
be recorded in self-reported SSI. Wound type will be decided according to documentation of
clinician who evaluates the wound. If a superficial SSI progresses into a deep SSI, it will
be reported as the deep SSI only. It may be possible for a subject to have an organ/space SSI
in addition to a SSI affecting the incision (superficial or deep) but if more than one SSI is
reported each must meet the case definition.
