The Use of Autologous Amniotic Fluid at Cesarean Wound Closure
The Use of Autologous Amniotic Fluid at Cesarean Wound Closure
The purpose of this study is to determine the feasibility of collecting amniotic fluid at
 delivery that will be immediately processed and then applied as a spray to the various layers
 of cesarean wound closure.
This is a single-site, prospective pilot study involving the collection of amniotic fluid at
 cesarean delivery followed by the immediate processing and re-application to the closure
 among twenty women at term undergoing cesarean delivery at Duke University Hospital. The
 objective of the study is to determine the feasibility of collection and application of
 autologous amniotic fluid at cesarean delivery.

 VISIT 1: Screening/Enrollment Visit:

 Once informed consent is obtained, demographic information, as well as medical and surgical
 history will be obtained. A medical release form will also be signed so that in the event
 that the subject is seen outside the Duke Health system after delivery, the study team will
 be able to request pertinent medical records.

 VISIT 2: Day of Surgery Visit:

 At presentation for delivery, study team members will reconfirm eligibility criteria.
 Subjects will then undergo cesarean delivery as per standard care.

 The Recibio kit includes the following supplies, all of which are packaged in a sterile kit
 and will be opened onto the sterile surgical field:

 -  Mucous trap

 -  Yankauer suction device

 -  Tubing to connect to wall suction

 -  10 ml syringe

 -  1 ml syringe

 -  Syringe spray applicator and spray tip with attached syringes - the spray device is
 included in sterile packaging and manufactured and distributed by Recibio, Inc. Ratio
 Applicator Kit, Ref # 2101 with an have FDA clearance via Class 1 exempt device FDA
 listing number D377967.

 10% calcium chloride vials will be provided separately. Vials will not be placed on the
 sterile field as it will likely not have sterile packaging. The calcium chloride
 solution will either be poured into a small sterile bowl so that it may be drawn up into
 the1 cc device syringe in a sterile manner OR drawn up into the device syringe directly
 by a member of the sterile surgical team while a member of the study team holds the
 non-sterile portion of the vial.

 The sterile supplies will be placed on the surgical table and set up for use prior to the
 start of the cesarean section. The surgery will begin and be completed as part of standard of
 care.

 Once the uterine incision has been made the following steps will be taken:

 Following incision of the lower uterine segment, the amniotic sac will be opened with an
 amniotic perforator.

 The Yankauer will be used to suction the amniotic fluid into the mucous trap as it escapes
 from the amniotic cavity.

 After delivery of the newborn and placenta and the uterine incision closed, the amniotic
 fluid will be drawn from the mucous trap into the 10 ml syringe

 The 10 mL syringe containing the amniotic fluid will then be observed for gross contamination
 (i.e. vertex, meconium-staining) and then attached to the spray device.

 The 1 ml syringe containing 1 ml of 10% calcium chloride will then also be attached to the
 spray device via the second port (final concentration of 1% once sprayed).

 The amniotic fluid-calcium chloride mixture will then be sprayed (1.5 to 2.0 ml) across the
 closed uterine incision and lower uterine segment.

 Next the fascia will be closed and the fascial incision sprayed (1.5 to 2.0 ml).

 Finally, the subcutaneous tissue will be closed and sprayed (1.5 to 2.0 ml) and then the skin
 will be closed and sprayed (1.5 to 2.0 ml).

 A photo of the closed incision will be taken prior to the application of any bandages.

 The incision will then be dressed as part of standard practice.

 Any extra amniotic fluid will be kept and stored at -80 degrees in the Duke Reproductive
 Biology and Perinatal Research Laboratory for potential future research.

 Since this study is testing product feasibility, only licensed investigators that are
 included as study personnel will be permitted to apply CeaLogic to the various tissue layers
 as described above.

 Data elements regarding certain time points during surgery, use of the CeaLogic, and any
 complications will be recorded. These include, but are not limited to:

 Procedure start time (incision time)

 Time of uterine incision

 Approximate volume of amniotic fluid collected

 Description of amniotic fluid (color, presence/absence of vertex, blood, or
 meconium-staining)

 Time that uterine closure is complete

 Approximate spray volume to closed uterine incision

 Approximate spray volume to closed abdominal fascia

 Approximate spray volume to closed subcutaneous tissue

 Approximate spray volume to closed skin

 Procedure end time

 Estimated blood loss

 Type of skin closure

 VISIT 3: Day of Discharge Visit:

 The subject will receive routine post-operative care during the immediate post-operative
 period. Most cesarean section patients are discharged home on post-operative day 2 or 3. The
 following study activities will occur at this visit:

 A photo of the incision site

 Assessment of the incision site that includes presence of redness, swelling, induration, as
 well as pain at rest and with gentle pressure

 The amount of pain medication used since delivery (non-steroidal anti-inflammatory agents and
 narcotics)

 The patient will be provided with a memory aid to record pain level and any pain medications
 that she takes once she goes home.

 An instruction form on how to complete the memory aid, as well as study team contact
 information, should the patient have questions or problems related to her incision.

 Scheduling of the first follow up visit that will occur 6-8 days after surgery.

 The study team will monitor the subject's medical record for vital signs and record any
 evidence of post-operative fever (maternal temperature greater than 38 degrees C its source,
 and action taken by the care team.

 Documentation of any adverse events

 VISIT 4: 1 Week Follow Up Visit:

 Subjects will be seen at the Duke Perinatal Research Center approximately one week following
 her procedure (post-operative day 6-8).

 At this visit the following study procedures will occur:

 Photo of the wound

 Assessment of the incision

 Documentation of any signs or symptoms of infection

 Review of the subject's memory aid for pain and pain medication

 Documentation of any adverse events

 Scheduling of the next study visit (approximately 4 weeks post-delivery)

 VISIT 5: 4 Week Follow Up Visit:

 Subjects will be seen during the routine postpartum clinic visit at approximately 4 weeks
 following delivery.

 At this visit the following study procedures will occur:

 Photo of the wound

 Assessment of the incision

 Documentation of any signs or symptoms of infection

 Documentation of any adverse events

 Review of the subject's memory aid for pain and pain medication

 VISIT 6: Phone Call Follow Up Visit:

 The subject will be contacted by telephone by a member of the study team approximately 6
 weeks after delivery to determine if she had any wound complications since her last visit. If
 so, the subject's medical record will be reviewed to determine if there were any
 complications or treatment pertaining to her cesarean section incision. If the subject
 received this care outside of the Duke Health system, the signed medical records release will
 be sent to the applicable health care facility to request pertinent to be reviewed. An
 IRB-approved phone script will be used for this phone call. The subject will also be asked a
 series of questions pertaining to medication use, pain at the incision site, and activity
 level. Adverse events will be documented if they have occurred.

 Unscheduled Study Visit:

 If a study subject contacts the study team with concern for complications with her cesarean
 section wound, an unscheduled visit will be completed. This visit can happen anytime during
 the subject's participation(up to 30 days following the procedure where the procedure day is
 day 1), but after the CeaLogic has been applied.

 During this visit, study staff will perform the following study procedures:

 Photo of the wound

 Assessment of the incision

 Documentation of any signs or symptoms of infection

 Documentation of adverse events

 Review of medical record for any treatment actions taken related to the cesarean section
 wound

 Product Use questionnaire:

 In addition to the above study activities, each time a licensed investigator uses CeaLogic,
 they will be asked to complete a short questionnaire about their experience with using the
 device. No personal identifying information will be captured in this questionnaire.
 Information gathered from these questionnaires will be compiled and given to the sponsor for
 feedback and possible product improvements.
Inclusion Criteria:

 1. Pregnant female age great than 18 years

 2. Singleton gestation

 3. Plan for cesarean delivery

 4. Planned gestational age of at least weeks at the time of delivery

 5. English speaking

 6. Able to provide own informed consent

 7. Intention of being available for entire study period and complete all relevant study
 procedures, including follow-up study visits and phone calls

 Exclusion criteria at screening/enrollment:

 1. Diabetes requiring therapy (type I or type II diabetes, gestational diabetes on
 medical therapy)

 2. BMI greater than or equal to 40 kg/m2 at the time of enrollment

 3. Placenta previa or placenta accreta

 4. Prior bowel or urologic surgery (except un-ruptured appendectomy or uncomplicated
 cholecystectomy)

 5. Multiple gestation

 6. Previous history of postpartum hemorrhage requiring medical or surgical treatment

 7. Known or suspected impairment of immunologic function including infection with HIV,
 hepatitis B or C

 8. Known tobacco or drug use

 9. Any condition which, in the opinion of the investigator, may pose a health risk to the
 subject or interfere with the evaluation of the study objectives

 10. History of keloid formation

 Exclusion criteria at time of surgery:

 1. Labor at time of presentation to labor and delivery (regular, painful uterine
 contractions occurring every 5 minutes with evidence of cervical change)

 2. Chorioamnionitis or other systemic infection at time of presentation for cesarean
 section, including evidence of lower abdominal skin infection (i.e. yeast, etc)

 3. Need for urgent Cesarean section (examples include, but not limited to: non-reassuring
 fetal status (category II or III tracing), placental abruption, severe preeclampsia or
 eclampsia)

 4. Rupture of membranes prior to the start of the surgery

 5. Meconium-stained or blood-stained amniotic fluid

 6. Experiences intraoperative hemorrhage requiring transfusion,
 disseminated-intravascular coagulopathy (DIC), or other medical or surgical condition
 during the delivery deemed by the investigator to pose a prohibitively high risk for
 surgical re-exploration or wound complication.

 7. Who, in the investigator's opinion, would have any clinically significant condition
 that would impair the patient's ability to comply with the study procedures

 8. Need for vertical skin incision

 9. Intraoperative use of hemostatic agent (examples include FLOSEAL and AVIGUARD®)

 10. Plan for use of staples at closure of the skin incision

 11. Preeclampsia with severe features