Banner University Medical Center Tucson
Tucson, Arizona, 85724, United States
NCT Number: NCT03082664
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).
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Notify Me18 year and older
Female
Interventional
Not applicable
Tucson, Arizona, 85724, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The PICO device will be placed over the closed cesarean section incision.
Other names: Smith & Nephew PICO patch
Time frame: post operative day 1-42
Number of study participants with a wound complication including wound breakdown, infection, separation or dehiscence
University of Arizona
Other
Topical Negative Pressure Wound Therapy to Prevent Wound Complications Following Cesarean Section in High Risk Obstetric Patients
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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