Cesarean Section ComplicationsPhase 4NCT03887299

Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery

A Phase 4 study testing ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG) and Standard Wound Care in people with Cesarean Section Complications and Wound Breakdown, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This will be an open label pilot randomized controlled clinical trial. Women undergoing cesarean delivery will be randomized to have standard wound dressing care or chlorohexidine gluconate (CHG) impregnated wound dressing (ReliaTect™ Post-Op Dressing). Read more about this study

Who is it for?: Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for: Cesarean Section Complications, Wound Breakdown, Wound Infection
What is being tested?: ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG) and Standard Wound Care
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 154 participants
Where: 1 siteUnited States
Study dates: 18 Apr 2019to 28 Feb 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 50 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

18-50 years of age.
Women ≥ 24 weeks' viable gestation.
To undergo cesarean delivery.
Admission BMI ≥ 35.

Who cannot join

Patient unwilling or unable to provide consent.
No prenatal care or a non-resident patient who is unlikely to be followed-up after delivery.
Immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4 <200, or other.
Decision not to have skin closure (e.g. secondary wound closure, mesh closure).
Current skin infection.
Coagulopathy.

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High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, bowel or adnexal surgery).
Known allergy to CHG.
Incarcerated individuals.
Chorioamnionitis.
Subjects participating on other treatment trials or studies that would interfere with the current study's primary outcome.

Trial locations and contacts

1 site in 1 country.

United States1 site

Ashley Salazar
Galveston, Texas, 77555

Other trials in United States

About this study

Official title: Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery: A Randomized Control Trial

Read the detailed description

Subjects requiring cesarean delivery and without exclusion criteria will be informed by the obstetrical team about the study and asked for permission to contact the study personnel. Written informed consent will be obtained by person-to-person contact. The research staff will be responsible for the informed consent.

Subjects who agree to participate in the study will be randomized to one of the two groups below in a 1/1 allocation:

Standard Wound Care: Wound dressing and care as per our current practice. Compression dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively. Dressing will be removed after 24 hours from surgery completion and subjects will have an absorption pad with overlying garments for the remaining postoperative days until standard postoperative visit for wound check.
CHG Wound Care: ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's instructions (Appendix A) intraoperatively. The dressing will be in place until the postoperative clinic visit on postoperative day 7.

The remainder of the subjects' care will be similar for both arms and will follow current standard clinical practice at the University of Texas Medical Branch (UTMB).

Conditions: Cesarean Section Complications, Wound Breakdown, Wound Infection, Satisfaction, Surgical Wound Infection
Being tested: ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG), Standard Wound Care
Keywords: Cesarean, Wound care, Wound complication, Surgical site infection
Medical subject headings: Surgical Wound Dehiscence, Wound Infection, Personal Satisfaction, Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG)Combination product
Also called Dressing containing CHG a disinfectant and antiseptic that is used for skin disinfection
Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7
Standard Wound CareOther
Wound care will be administered as standard protocol in our institution

Study groups in NCT03887299
Study group	Role	What they receive
Standard Wound Care	Placebo comparator	Wound dressing and care as per our current practice. Compression dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively. Dressing will be removed after 24 hours from surgery completion and subjects will have an absorption pad with overlying garments for the remaining postoperative days until standard postoperative visit for wound check. Receives: Other: Standard Wound Care
CHG Wound Care	Active comparator	ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's instructions intraoperatively. The dressing will be in place until the postoperative clinic visit on postoperative day 7. Receives: Combination Product: ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG)

What is being measured

The primary outcome is the main question the study is designed to answer.

Satisfaction and QoL Questionnaire
We will be assessing through a survey patient satisfaction concerning dressing received and assess the quality of life while receiving either intervention (5 point Richter scale). A maximum score of 5: Strongly agree and a minimum score of 1: Strongly disagree.
A higher score means a better outcome.
Measured: Postpartum wound care visit (up to 10days postpartum)

Secondary outcomes (5)

Number of Participants With Composite Wound Complication
Defined as presence of any of the following within 30 days from surgery: Wound infection: Presence of either superficial or deep incisional SSI described as cellulitis/erythema and induration around the incision or purulent discharge from the incision site, with or without fever, such as necrotizing fasciitis (diagnosed based on necrotizing wound infection). Wound hematoma, seroma, or breakdown alone. (yes or No)
Measured: 30 days postpartum
Number of Participants With Wound Breakdown
Opening of wound incision documented in the chart at the provider's discretion(Yes or No)
Measured: 30 days postpartum
Number of Participants That Resulted in Maternal Death
Death of participant during hospital stay (Yes or No)
Measured: 4 days postpartum
Number of Participants With Puerperal Fever
Temperature > 100.4oF after first 24 hours or ≥101 oF any time. (Yes or No)
Measured: 4 days postpartum
Provider Satisfaction
Assessing health care providers opinion on the dressing care (5 point Richter scale). A maximum score of 5: Strongly agree and a minimum score of 1: Strongly disagree.
A higher score means a better outcome.
Measured: Postpartum wound care visit (up to 10days postpartum)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Apr 201928 Feb 2020

First posted22 Mar 2019
Study start18 Apr 2019
Primary completion18 Jan 2020
Study completion28 Feb 2020

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.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
More trials run by The University of Texas Medical Branch, GalvestonThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Open label randomized control trial
Masking: None (open label)
Enrolment: 154 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03887299
Sponsor's protocol ID: 18-0265
Status last verified: Mar 2019
First submitted: 21 Mar 2019
Last updated: 5 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Publications

Allegranzi B, Zayed B, Bischoff P, Kubilay NZ, de Jonge S, de Vries F, Gomes SM, Gans S, Wallert ED, Wu X, Abbas M, Boermeester MA, Dellinger EP, Egger M, Gastmeier P, Guirao X, Ren J, Pittet D, Solomkin JS; WHO Guidelines Development Group. New WHO recommendations on intraoperative and postoperative measures for surgical site infection prevention: an evidence-based global perspective. Lancet Infect Dis. 2016 Dec;16(12):e288-e303. doi: 10.1016/S1473-3099(16)30402-9. Epub 2016 Nov 2.
PubMed 27816414
Berg CJ, Chang J, Callaghan WM, Whitehead SJ. Pregnancy-related mortality in the United States, 1991-1997. Obstet Gynecol. 2003 Feb;101(2):289-96. doi: 10.1016/s0029-7844(02)02587-5.
PubMed 12576252
DeFrances CJ, Cullen KA, Kozak LJ. National Hospital Discharge Survey: 2005 annual summary with detailed diagnosis and procedure data. Vital Health Stat 13. 2007 Dec;(165):1-209.
PubMed 18350768
Gibbs RS. Clinical risk factors for puerperal infection. Obstet Gynecol. 1980 May;55(5 Suppl):178S-184S. doi: 10.1097/00006250-198003001-00045.
PubMed 6990333
Saad AF, Salazar AE, Allen L, Saade GR. Antimicrobial Dressing versus Standard Dressing in Obese Women Undergoing Cesarean Delivery: A Randomized Controlled Trial. Am J Perinatol. 2022 Jul;39(9):951-958. doi: 10.1055/s-0040-1721112. Epub 2020 Dec 2.
PubMed 33264808

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection

All Cesarean Section Complications trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery: A Randomized Control Trial
ClinicalTrials.gov ID: NCT03887299
Acronym / sponsor ID: 18-0265
Conditions: Cesarean Section Complications, Wound Breakdown, Wound Infection, Satisfaction, Surgical Wound Infection
Keywords: Cesarean, Wound care, Wound complication, Surgical site infection
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 154 participants (actual)
Lead sponsor: The University of Texas Medical Branch, GalvestonUniversity, hospital or other
Study start: 18 Apr 2019 (actual)
Primary completion: 18 Jan 2020 (actual)
Study completion: 28 Feb 2020 (actual)
First posted: 22 Mar 2019 (actual)
Results: Posted 5 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Subjects who agree to participate in the study will be randomized to one of the two groups below in a 1/1 allocation:

Standard Wound Care: Wound dressing and care as per our current practice. Compression dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively. Dressing will be removed after 24 hours from surgery completion and subjects will have an absorption pad with overlying garments for the remaining postoperative days until standard postoperative visit for wound check.
CHG Wound Care: ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's instructions (Appendix A) intraoperatively. The dressing will be in place until the postoperative clinic visit on postoperative day 7.

The remainder of the subjects' care will be similar for both arms and will follow current standard clinical practice at the University of Texas Medical Branch (UTMB).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Open label randomized control trial

Arm	Type	Receives
Standard Wound Care	Placebo comparator	Other: Standard Wound CareWound dressing and care as per our current practice. Compression dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively. Dressing will be removed after 24 hours from surgery completion and subjects will have an absorption pad with overlying garments for the remaining postoperative days until standard postoperative visit for wound check.
CHG Wound Care	Active comparator	Combination Product: ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG)ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's instructions intraoperatively. The dressing will be in place until the postoperative clinic visit on postoperative day 7.

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

18-50 years of age.
Women ≥ 24 weeks' viable gestation.
To undergo cesarean delivery.
Admission BMI ≥ 35.

Key exclusion criteria (11 listed)

Patient unwilling or unable to provide consent.
No prenatal care or a non-resident patient who is unlikely to be followed-up after delivery.
Immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4 <200, or other.
Decision not to have skin closure (e.g. secondary wound closure, mesh closure).
Current skin infection.

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
ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG)Also: Dressing containing CHG a disinfectant and antiseptic that is used for skin disinfectionDressing will be applied in the operating room at the end of case and be in place until postoperative day 7	Combination product	CHG Wound Care
Standard Wound CareWound care will be administered as standard protocol in our institution	Other	Standard Wound Care

Primary outcome

Satisfaction and QoL Questionnaire
Time frame: Postpartum wound care visit (up to 10days postpartum)
We will be assessing through a survey patient satisfaction concerning dressing received and assess the quality of life while receiving either intervention (5 point Richter scale). A maximum score of 5: Strongly agree and a minimum score of 1: Strongly disagree. A higher score means a better outcome.

5 secondary outcomes

Number of Participants With Composite Wound Complication
Time frame: 30 days postpartum
Number of Participants With Wound Breakdown
Time frame: 30 days postpartum
Number of Participants That Resulted in Maternal Death
Time frame: 4 days postpartum
Number of Participants With Puerperal Fever
Time frame: 4 days postpartum
Provider Satisfaction
Time frame: Postpartum wound care visit (up to 10days postpartum)

Results and safety

Results posted to the registry on 5 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Wound Care	77	77
CHG Wound Care	77	77

Primary outcome: Satisfaction and QoL Questionnaire

Time frame: Postpartum wound care visit (up to 10days postpartum). Median (Full Range). Unit: Score

Measure	Standard Wound Care n = 77	CHG Wound Care n = 77
Value	49 (20 to 55)	52 (12 to 55)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected up to 9 months from subject randomization.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Wound Care	0 of 77 (0%)	0 of 77 (0%)	0 of 77
CHG Wound Care	0 of 77 (0%)	0 of 77 (0%)	0 of 77

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27816414Allegranzi B, Zayed B, Bischoff P, Kubilay NZ, de Jonge S, de Vries F, Gomes SM, Gans S, Wallert ED, Wu X, Abbas M, Boermeester MA, Dellinger EP, Egger M, Gastmeier P, Guirao X, Ren J, Pittet D, Solomkin JS; WHO Guidelines Development Group. New WHO recommendations on intraoperative and postoperative measures for surgical site infection prevention: an evidence-based global perspective. Lancet Infect Dis. 2016 Dec;16(12):e288-e303. doi: 10.1016/S1473-3099(16)30402-9. Epub 2016 Nov 2.
Background: PubMed 12576252Berg CJ, Chang J, Callaghan WM, Whitehead SJ. Pregnancy-related mortality in the United States, 1991-1997. Obstet Gynecol. 2003 Feb;101(2):289-96. doi: 10.1016/s0029-7844(02)02587-5.
Background: PubMed 18350768DeFrances CJ, Cullen KA, Kozak LJ. National Hospital Discharge Survey: 2005 annual summary with detailed diagnosis and procedure data. Vital Health Stat 13. 2007 Dec;(165):1-209.
Background: PubMed 6990333Gibbs RS. Clinical risk factors for puerperal infection. Obstet Gynecol. 1980 May;55(5 Suppl):178S-184S. doi: 10.1097/00006250-198003001-00045.
Derived from this study: PubMed 33264808Saad AF, Salazar AE, Allen L, Saade GR. Antimicrobial Dressing versus Standard Dressing in Obese Women Undergoing Cesarean Delivery: A Randomized Controlled Trial. Am J Perinatol. 2022 Jul;39(9):951-958. doi: 10.1055/s-0040-1721112. Epub 2020 Dec 2.
Individual participant dataSharing planned: No

Related trials for Cesarean Section Complications

Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
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Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection

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.

Antonio F. Saad, MD principal investigator

UTMB Galveston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 11 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: finished, as of the sponsor's last update on 5 Oct 2021. 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. Some participants in this study may receive a placebo. 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 5 Oct 2021). 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?

Satisfaction and QoL Questionnaire (time frame: Postpartum wound care visit (up to 10days postpartum)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03887299, which also lists 5 linked publications.

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 5 Oct 2021.