Cesarean Section Complications, Satisfaction, Surgical Wound Infection, Wound Breakdown, Wound Infection
Conditions
Keywords
Cesarean, Wound care, Wound complication, Surgical site infection
Brief 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).
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).
Interventions
COMBINATION_PRODUCTReliaTect™ 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
OTHERStandard Wound Care
Wound care will be administered as standard protocol in our institution
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Data analysis will be blinded to assignment including the principal investigator.
Intervention model description
Open label randomized control trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-50 years of age. * Women ≥ 24 weeks' viable gestation. * To undergo cesarean delivery. * Admission BMI ≥ 35.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction and QoL Questionnaire | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Composite Wound Complication | 30 days postpartum | 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) |
| Number of Participants With Wound Breakdown | 30 days postpartum | Opening of wound incision documented in the chart at the provider's discretion(Yes or No) |
| Number of Participants That Resulted in Maternal Death | 4 days postpartum | Death of participant during hospital stay (Yes or No) |
| Number of Participants With Puerperal Fever | 4 days postpartum | Temperature \> 100.4oF after first 24 hours or ≥101 oF any time. (Yes or No) |
| Provider Satisfaction | Postpartum wound care visit (up to 10days postpartum) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 77 |
| CHG Wound Care 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.
ReliaTect™ 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 | 77 |
| Total | 154 |
Baseline characteristics
| Characteristic | Standard Wound Care | CHG Wound Care | Total |
|---|---|---|---|
| Age, Continuous | 29 years | 29 years | 29 years |
| Delivery complications | 12 Participants | 8 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 37 Participants | 47 Participants | 84 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 30 Participants | 70 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Medical Condition | 27 Participants | 23 Participants | 50 Participants |
| Region of Enrollment United States | 77 participants | 77 participants | 154 participants |
| Sex: Female, Male Female | 77 Participants | 77 Participants | 154 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Skin closure with staples | 44 Participants | 43 Participants | 87 Participants |
| Vertical Skin incision | 8 Participants | 6 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 77 | 0 / 77 |
| other Total, other adverse events | 0 / 77 | 0 / 77 |
| serious Total, serious adverse events | 0 / 77 | 0 / 77 |
Outcome results
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.
Time frame: Postpartum wound care visit (up to 10days postpartum)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Wound Care | Satisfaction and QoL Questionnaire | 49 Score |
| CHG Wound Care | Satisfaction and QoL Questionnaire | 52 Score |
Secondary
Number of Participants That Resulted in Maternal Death
Death of participant during hospital stay (Yes or No)
Time frame: 4 days postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Wound Care | Number of Participants That Resulted in Maternal Death | 0 Participants |
| CHG Wound Care | Number of Participants That Resulted in Maternal Death | 0 Participants |
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)
Time frame: 30 days postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Wound Care | Number of Participants With Composite Wound Complication | 5 Participants |
| CHG Wound Care | Number of Participants With Composite Wound Complication | 9 Participants |
Secondary
Number of Participants With Puerperal Fever
Temperature \> 100.4oF after first 24 hours or ≥101 oF any time. (Yes or No)
Time frame: 4 days postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Wound Care | Number of Participants With Puerperal Fever | 0 Participants |
| CHG Wound Care | Number of Participants With Puerperal Fever | 1 Participants |
Secondary
Number of Participants With Wound Breakdown
Opening of wound incision documented in the chart at the provider's discretion(Yes or No)
Time frame: 30 days postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Wound Care | Number of Participants With Wound Breakdown | 1 Participants |
| CHG Wound Care | Number of Participants With Wound Breakdown | 0 Participants |
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.
Time frame: Postpartum wound care visit (up to 10days postpartum)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Wound Care | Provider Satisfaction | 17 Score |
| CHG Wound Care | Provider Satisfaction | 21 Score |