Surgical Site InfectionPhase 4NCT03401749
Preadmission Skin Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery Patients
A Phase 4 study testing Chlorhexidine Gluconate 2% Wipe and Theraworx Bath Wipes in people with Surgical Site Infection, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Intervention: This study will involve three different study arms with different interventions prior to surgery: (1) shower only, (2) shower plus Theraworx wipes, (3) shower plus chlorhexidine wipes Study Design: Single center RCT Sample Size: 500 patients, aged 18+ Objectives: Primary Objectives: 1. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Chlorhexidine Gluconate 2% Wipe and Theraworx Bath Wipes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 1 Dec 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patient between ages 18-64
- Scheduled and deemed healthy enough to undergo orthopaedic surgery
- Willing and able to comply with protocol
Who cannot join
- Clinical signs of infection
- Contraindication to CHG or Theraworx
- Previous allergic reaction to CHG or Theraworx
- Surgeon's Discretion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Preadmission Theraworx Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery Patients: A Randomized Controlled Trial
Intervention: This study will involve three different study arms with different interventions prior to surgery: (1) shower only, (2) shower plus Theraworx wipes, (3) shower plus chlorhexidine wipes
Study Design: Single center RCT
Read more
Sample Size: 500 patients, aged 18+
Objectives: Primary Objectives:
- Monitor for safety and adverse effects.
- Evaluate for differences in peri-operative skin cultures between treatment groups;
- Compare surgical site infection rates between groups.
Secondary Objectives:
- Assess for patient compliance for each different treatment arms.
- Measure patient satisfaction.
- Measure nurse satisfaction.
- Visual assessment of wound healing
Expected Results: We expect no statistically significant difference in peri-operative cultures or surgical site infection rates between groups.
- Conditions
- Surgical Site Infection
- Being tested
- Chlorhexidine Gluconate 2% Wipe, Theraworx Bath Wipes
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine Gluconate 2% WipeDrug
Patients will be instructed to use CHG wipes after showering the night before surgery and again on the morning of surgery.
Theraworx Bath WipesOther
Also called Theraworx
Theraworx TM is a cosmetic product that is a non-rinse skin formulation that combines multiple ingredients, including Aloe Concentrate, Allantoin, Tego Betaine F 50, Tego Betaine L-7, Lauryl Glucoside, Abil 8852, Vitamin E, Natural Fragrances, Methyl paraben, Propyl paraben, EDTA, Antimicrobial Preservative, Colloidal Silver, and Beta Glucan, in preoperative disposable bath wipes. The main proposed antimicrobial mechanism of action involves the local reduction in skin pH to around 4.6.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Usual preadmission surgery instructions (shower the night before). |
| Theraworx Group | Experimental | Usual preadmission surgery instructions (shower the night before) plus theraworx skin wipe system use the night before surgery and 1 hour before surgery. Receives: Other: Theraworx Bath Wipes |
| CHG Group | Experimental | Usual preadmission surgery instructions (shower the night before) plus chlorhexidine gluconate (CHG) skin wipe system use the night before surgery and 1 hour before surgery. Receives: Drug: Chlorhexidine Gluconate 2% Wipe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Developed a Surgical Site Infection
Clinical development of a surgical site infection in the postoperative period.
Measured: Within 1 year of Surgery
Secondary outcomes (1)
Number of Patients Compliant With the Requirement of Their Study Group
Survey on patient's ability to follow the study guidelines. For example, if the patient was placed in the Theraworx study group, did they properly follow the instructions to shower and use the Theraworx skin wipe system the night before surgery.
Measured: Day before and day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 Nov 2018
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Why it stopped: Funding issues, poor recruiting and compliance of the patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashish Shah, University of Alabama at Birmingham
- Investigators
- ashish shah, md, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401749
- Sponsor's protocol ID
- IRB-300000508
- Status last verified
- Apr 2022
- First submitted
- 10 Jan 2018
- Last updated
- 2 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Preadmission Theraworx Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03401749
- Acronym / sponsor ID
- IRB-300000508
- Conditions
- Surgical Site Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding issues, poor recruiting and compliance of the patients.
- Enrolment
- 203 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Posted 4 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intervention: This study will involve three different study arms with different interventions prior to surgery: (1) shower only, (2) shower plus Theraworx wipes, (3) shower plus chlorhexidine wipes
Study Design: Single center RCT
Sample Size: 500 patients, aged 18+
Objectives: Primary Objectives:
- Monitor for safety and adverse effects.
- Evaluate for differences in peri-operative skin cultures between treatment groups;
- Compare surgical site infection rates between groups.
Secondary Objectives:
- Assess for patient compliance for each different treatment arms.
- Measure patient satisfaction.
- Measure nurse satisfaction.
- Visual assessment of wound healing
Expected Results: We expect no statistically significant difference in peri-operative cultures or surgical site infection rates between groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Usual preadmission surgery instructions (shower the night before). |
| Theraworx Group | Experimental | Other: Theraworx Bath WipesUsual preadmission surgery instructions (shower the night before) plus theraworx skin wipe system use the night before surgery and 1 hour before surgery. |
| CHG Group | Experimental | Drug: Chlorhexidine Gluconate 2% WipeUsual preadmission surgery instructions (shower the night before) plus chlorhexidine gluconate (CHG) skin wipe system use the night before surgery and 1 hour before surgery. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult patient between ages 18-64
- Scheduled and deemed healthy enough to undergo orthopaedic surgery
- Willing and able to comply with protocol
Key exclusion criteria (4 listed)
- Clinical signs of infection
- Contraindication to CHG or Theraworx
- Previous allergic reaction to CHG or Theraworx
- Surgeon's Discretion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine Gluconate 2% WipePatients will be instructed to use CHG wipes after showering the night before surgery and again on the morning of surgery. | Drug | CHG Group |
| Theraworx Bath WipesAlso: TheraworxTheraworx TM is a cosmetic product that is a non-rinse skin formulation that combines multiple ingredients, including Aloe Concentrate, Allantoin, Tego Betaine F 50, Tego Betaine L-7, Lauryl Glucoside, Abil 8852, Vitamin E, Natural Fragrances, Methyl paraben, Propyl paraben, EDTA, Antimicrobial Preservative, Colloidal Silver, and Beta Glucan, in preoperative disposable bath wipes. The main proposed antimicrobial mechanism of action involves the local reduction in skin pH to around 4.6. | Other | Theraworx Group |
Primary outcome
Number of Participants That Developed a Surgical Site Infection
Time frame: Within 1 year of Surgery
Clinical development of a surgical site infection in the postoperative period.
1 secondary outcome
Number of Patients Compliant With the Requirement of Their Study Group
Time frame: Day before and day of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ashish shah, md principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chlorhexidine Gluconate 2% Wipe and Theraworx Bath Wipes in people with Surgical Site Infection, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Developed a Surgical Site Infection (time frame: Within 1 year of Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.