Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized controlled trial. Patients with a condition that increases their risk of a wound complication will be approached for inclusion in the trial. Each participant agreeing to study inclusion will be randomized to either suture alone or to closure of their skin incision with suture and then with prophylactic placement of a wound vac (PICO).
Once consent has been obtained from patients, an envelope containing the study allocation will be retrieved from the Pyxis.
It would be unrealistic to try to standardize the entire operative approach (closure of the uterus, closure of the fascia) as the different providers working at the hospital may choose not to participate if the approach specified deviated too much from their usual technique. Different providers may typically use different kinds or sutures (made of different material, and of different sizes) or staples to close the subcutaneous fat and the skin. However, for this study all patients will have the subcutaneous fat and skin closed in the same manner (with Vicryl suture). To participate in the trial patients will have to agree to these closure materials. For this study a standard closure with suture was chosen as there is evidence suggesting a lower rate of wound complications with suture as compared to staples.
The wound will be re-assessed at their 2 week and 6 week post-op follow up visits. The patients will be assessed by a physician at their post-operative clinic visits. The physician/investigator will ask the patient if they have had any postoperative complications since their surgery and will be asked to detail any complications if they answer yes to this question. The investigators will also obtain permission to call the participants for a patient satisfaction questionnaire at 1 week post-op, and possibly 2 and 6 weeks if they have not presented for their post op/partum appointments or the questionnaire could not be obtained at their visit.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard dressing | No Intervention | Standard dressing will be applied after C-section. | |
| PICO dressing | Experimental | Device: PICO Single Use Negative Pressure Wound Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PICO Single Use Negative Pressure Wound Therapy | Device | The PICO device will be placed over the closed cesarean section incision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound Complication | Number of study participants with a wound complication including wound breakdown, infection, separation or dehiscence | post operative day 1-42 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Meghan Hill, MBBS | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center Tucson | Tucson | Arizona | 85724 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37140175 | Derived | Gonzalez MG, Barske ME, Kjellsson KB, Saboda K, Reed HA, Hill MG. Topical negative pressure wound therapy to prevent wound complications following caesarean delivery in high-risk obstetric patients: A randomised controlled trial. Aust N Z J Obstet Gynaecol. 2023 Aug;63(4):516-520. doi: 10.1111/ajo.13675. Epub 2023 May 4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Standard Dressing | Standard dressing will be applied after C-section. |
| FG001 | PICO Dressing | Device: PICO Single Use Negative Pressure Wound Therapy PICO Single Use Negative Pressure Wound Therapy: The PICO device will be placed over the closed cesarean section incision. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 18, 2017 | Sep 5, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard Dressing | Standard dressing will be applied after C-section. |
| BG001 | PICO Dressing | Device: PICO Single Use Negative Pressure Wound Therapy PICO Single Use Negative Pressure Wound Therapy: The PICO device will be placed over the closed cesarean section incision. |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Wound Complication | Number of study participants with a wound complication including wound breakdown, infection, separation or dehiscence | Participants who had any follow up at either 1, 2 or 6 weeks were included. | Posted | Count of Participants | Participants | post operative day 1-42 |
|
|
|
6 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Dressing | Standard dressing will be applied after C-section. | 0 | 75 | 0 | 75 | 0 | 75 |
| EG001 | PICO Dressing | Device: PICO Single Use Negative Pressure Wound Therapy PICO Single Use Negative Pressure Wound Therapy: The PICO device will be placed over the closed cesarean section incision. | 0 | 79 | 0 | 79 | 0 | 79 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Maritza G. Gonzalez | University of Chicago | 7737026118 | mggonzalez@bsd.uchicago.edu |
| Prot_000.pdf |
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|