- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01450631
The Use of the Prevena™ Incision Management System on Post-Surgical Cesarean Section Incisions
A Prospective, Randomized, Evaluation of the Prevena™ Incision Management System on Closed Incisions in Obese Subjects Undergoing Cesarean Section Surgery
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Duke University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
The Subject:
- is a female aged ≥ 18 years
- is able to provide her own informed consent
- will undergo a Cesarean section procedure using a subcuticular skin closure technique within the next 42 days
- will require a surgical incision able to be covered completely by the PIMS skin interface
- has a BMI ≥ 35 kg/m2 as determined during the Screening Period up to 42 days pre-surgery
is preoperatively assessed to undergo a procedure with a CDC Wound Classification of:
Class I (Clean): An uninfected operative wound in which no inflammation is encountered and the respiratory, alimentary, genital, or uninfected urinary tract is not entered
- OR -
- Class II (Clean Contaminated): An operative wound in which the respiratory, alimentary, genital, or uninfected urinary tract are entered under controlled conditions and without unusual contamination
- is willing and able to return for all scheduled and required study visits
- is not concurrently enrolled in another clinical intervention trial which may impact maternal health or the surgical site
Exclusion Criteria:
The Subject:
- is ASA Class P4, P5, or P6 (Appendix F - American Society of Anesthesiologists (ASA) Physical Status Classification System)
- has a systemic bacterial or fungal infection at the time of surgery
- has a remote-site skin infection at the time of surgery
- has a life expectancy of < 12 months
is preoperatively assessed to undergo a procedure with a CDC Wound Classification of:
Class III (Contaminated): Open, fresh, accidental wounds, and/or major breaks in sterile technique or gross spillage from the gastrointestinal tract
- OR -
- Class IV (Dirty-Infected): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera
- experiences intraoperative hemorrhage requiring transfusion, disseminated-intravascular coagulopathy (DIC) or other medical or surgical condition during the Cesarean section deemed by the investigator to pose a prohibitively high risk for surgical re-exploration
- who, in the investigator's opinion, would have any clinically significant condition that would impair the participant's ability to comply with the study procedures
- has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic adhesives
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard Dressing
Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.
|
The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™).
The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges.
After the dressing is removed, the surgical site is left exposed to air to promote further healing.
Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy.
Other Names:
|
Experimental: Prevena™ (PIMS)
PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.
|
PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe.
The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system.
The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.
It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions.
Additional alerts include system error and device life-cycle expiration (8 days).
It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device.
Wound fluids are contained within the 45 mL canister.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Postoperative Surgical Site Occurrences (SSOs) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery.
Time Frame: Post-op Day 42 (+/- 10 days) after Cesarean section surgery
|
Incidence of postoperative surgical site occurrences (SSOs) post Cesarean section surgery. SSOs include:
|
Post-op Day 42 (+/- 10 days) after Cesarean section surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence Rate of Surgical Incision Intervention (SII) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery.
Time Frame: Post-op Day: 42 (+/- 10 days) after Cesarean section surgery
|
Incidence rate of surgical incision intervention (SII) post Cesarean section surgery. Interventions include:
|
Post-op Day: 42 (+/- 10 days) after Cesarean section surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert Heine, MD, Duke University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- obesity
- pregnancy
- wound infection
- surgical site infection
- obese
- cesarean
- seroma
- hematoma
- cesarean delivery
- wound management
- incision
- nosocomial infection
- negative pressure wound therapy
- wound complication
- wound dehiscence
- post-operative complication
- surgical incision risk
- surgical incision infection
- cesarean section surgery
- surgical closure
- wound disruption
- subcutaneous approximation
- wound separation
- subcutaneous closure
- massive obesity
- superobesity
Additional Relevant MeSH Terms
Other Study ID Numbers
- AHS.2011.Prevena.Heine.03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Surgical Wound Infection
-
St. Borbala HospitalSemmelweis University; Department of Surgery, Jahn Ferend Dél-Pesti Kórház... and other collaboratorsTerminatedSurgical Wound | Surgical Site Infection | Wound Dehiscence, Surgical | Dehiscence of Internal Surgical WoundHungary
-
Centro Hospitalar do Tâmega e SousaActive, not recruitingSurgical Wound | Surgical Wound Infection | Surgical Site Infection | Surgical Wound, Healed | Surgical Complication | Surgical Wound Dehiscence | Surgical Wound HaemorrhagePortugal
-
University of Nevada, Las VegasRecruitingColorectal Disorders | Surgical Site Infection | Wound SurgicalUnited States
-
HITEC-Institute of Medical SciencesCompletedWound Infection | Wound Dehiscence | Wound Surgical | Wound BleedingPakistan
-
Hull University Teaching Hospitals NHS TrustUniversity of HullRecruitingSurgical Wound | Wound Infection | Surgical Incision | Infection, Bacterial | Wound Infection, SurgicalUnited Kingdom
-
Next Science TMUniversity of Maryland, BaltimoreWithdrawnSurgical Wound | Surgical Wound Infection | Surgical Site Infection | Surgical Incision | Amputation Stump; Infection
-
Associazione Infermieristica per lo studio delle...Unknown
-
Clinique OrtosCompleted
-
Imperial College LondonWithdrawnSurgical Wound | Surgical Site Infection | Wound Infection | Surgical Incision
-
Rothman Institute OrthopaedicsUnknownSurgical IncisionUnited States
Clinical Trials on Standard-of-care Dressing
-
United States Army Institute of Surgical ResearchCompleted
-
University of California, IrvineWithdrawnScarringUnited States
-
Jorge MarcetCompletedInfections | SurgeryUnited States
-
3MTerminatedAbdominoplasty | HerniorrhaphyUnited States
-
ULURU Inc.Navy Advanced Medical Development (NAMD) CommandActive, not recruitingWounds and InjuriesUnited States
-
OrganogenesisCompletedVenous UlcerUnited States
-
University Hospital, Clermont-FerrandMolnlycke Health Care ABUnknownUlcer | Skin Ulcer | Prevention | Pressure UlcersFrance
-
ULURU Inc.Naval Medical Research Center; Military Technology Enterprise Consortium (US)RecruitingDiabetic Foot UlcerUnited States
-
Dr. Jean E. Starr, MDUnknownObesity | Diabetes | Peripheral Vascular DiseaseUnited States
-
Istituto Ortopedico RizzoliCompleted