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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 (ReliaTectâ„¢ Post-Op Dressing).
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| CHG Wound Care | Active Comparator | ReliaTectâ„¢ 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReliaTectâ„¢ Post-Op Dressing (contains chlorohexidine gluconate or CHG) | Combination Product | Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Postpartum wound care visit (up to 10days postpartum) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Obstetrical population: Pregnant women undergoing cesarean section
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| Name | Affiliation | Role |
|---|---|---|
| Antonio F. Saad, MD | UTMB Galveston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ashley Salazar | Galveston | Texas | 77555 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27816414 | Background | 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. | |
| 12576252 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Standard Wound Care: Wound care will be administered as standard protocol in our institution |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 11, 2019 |
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Open label randomized control trial
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Data analysis will be blinded to assignment including the principal investigator.
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| Standard Wound Care | Other | Wound care will be administered as standard protocol in our institution |
|
| 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) | 30 days postpartum |
| Number of Participants That Resulted in Maternal Death | Death of participant during hospital stay (Yes or No) | 4 days postpartum |
| Number of Participants With Puerperal Fever | Temperature > 100.4oF after first 24 hours or ≥101 oF any time. (Yes or No) | 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. | Postpartum wound care visit (up to 10days postpartum) |
| Background |
| 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. |
| 18350768 | Background | 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. |
| 6990333 | Background | Gibbs RS. Clinical risk factors for puerperal infection. Obstet Gynecol. 1980 May;55(5 Suppl):178S-184S. doi: 10.1097/00006250-198003001-00045. |
| 33264808 | Derived | 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. |
| FG001 | CHG Wound Care | ReliaTectâ„¢ 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. ReliaTectâ„¢ Post-Op Dressing (contains chlorohexidine gluconate or CHG): Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Standard Wound Care: Wound care will be administered as standard protocol in our institution |
| BG001 | CHG Wound Care | ReliaTectâ„¢ 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. ReliaTectâ„¢ Post-Op Dressing (contains chlorohexidine gluconate or CHG): Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Medical Condition | Count of Participants | Participants |
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| Delivery complications | Count of Participants | Participants |
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| Vertical Skin incision | Count of Participants | Participants |
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| Skin closure with staples | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Full Range | Score | Postpartum wound care visit (up to 10days postpartum) |
|
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| |||||||||||||||||||||||||||||
| Secondary | 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) | Posted | Count of Participants | Participants | 30 days postpartum |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Wound Breakdown | Opening of wound incision documented in the chart at the provider's discretion(Yes or No) | Posted | Count of Participants | Participants | 30 days postpartum |
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| Secondary | Number of Participants That Resulted in Maternal Death | Death of participant during hospital stay (Yes or No) | Posted | Count of Participants | Participants | 4 days postpartum |
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| Secondary | Number of Participants With Puerperal Fever | Temperature > 100.4oF after first 24 hours or ≥101 oF any time. (Yes or No) | Posted | Count of Participants | Participants | 4 days postpartum |
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| Secondary | 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. | Posted | Median | Full Range | Score | Postpartum wound care visit (up to 10days postpartum) |
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Adverse event data was collected up to 9 months from subject randomization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Standard Wound Care: Wound care will be administered as standard protocol in our institution | 0 | 77 | 0 | 77 | 0 | 77 |
| EG001 | CHG Wound Care | ReliaTectâ„¢ 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. ReliaTectâ„¢ Post-Op Dressing (contains chlorohexidine gluconate or CHG): Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7 | 0 | 77 | 0 | 77 | 0 | 77 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antonio F Saad | University of Texas Medical Branch Galveston | 4097476646 | afsaad@utmb.edu |
| Sep 3, 2021 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D013529 | Surgical Wound Dehiscence |
| D014946 | Wound Infection |
| D010549 | Personal Satisfaction |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D002864 | Chromogranins |
| ID | Term |
|---|---|
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Participants |
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