Subcuticular Suture for Cesarean Skin Incision Closure
Condition: Complications; Cesarean Section; Surgical Wound Infection
MeSH terms: Wound Infection; Surgical Wound Infection; Surgical Wound
Study type: Interventional
Phase: Phase 4

Summary: 
      A comparison of the type of suture used for cesarean skin incision approximation and the
      subsequent rate of wound complications has not been widely studied. Investigators seek to
      compare poliglecaprone 25 and polyglactin 910 suture used in a subcuticular skin closure in
      Pfannenstiel incisions during cesarean birth and determine the subsequent wound complication
      rates (SSI, hematoma, seroma, wound separation).
    

Detailed description: 
      In the United States cesarean delivery rates in 2012 were 32.8%. The incidence of wound
      complications post-cesarean delivery has been quoted to be anywhere from 3-30%. Wound
      complications can include surgical site infection (SSI), hematoma, seroma, and wound
      separation. Risk factors for wound complications include elevated body mass index (BMI),
      prolonged duration of surgery, maternal diabetes, coexisting infection (chorioamnionitis),
      anemia, and increasing number of prior cesarean deliveries. The majority of cesarean
      deliveries are performed through a suprapubic low-transverse skin incision (Pfannenstiel
      incision). The incidence of wound complication post-cesarean comparing suture and staple skin
      closure has been extensively studied with the over all conclusion recommending suture skin
      closer.

      A comparison of the type of suture used for skin closer and wound complication has not been
      widely studied. Vats et al. compared three types of suture material in post-cesarean wound
      complication and found statistical difference in wound discomfort, swelling and induration,
      wound discharge, and wound dehiscence. Their quoted wound complication rate was as high as
      thirty-three percent. Although, their study population was limited to emergent cesarean
      deliveries, the sample size was small, and their method of randomization was not explained.

      Physiologic wound healing involves five steps: inflammation, granulation, epithelialization,
      wound contraction, and scar maturation. These biologic processes overlap in occurrence but
      happen in a defined order. Investigators hypothesize that suture materials with differing
      profiles will have different effects on these biologic processes. The two most widely used
      sutures for low-transverse cesarean skin incision closure in our institution are
      poliglecaprone 25 and polyglactin 910. Poliglecaprone 25 (monocryl) is a monofilament suture
      with an absorption profile of 91-119 days. Polyglactin 910 (coated vicryl) is a braided
      suture with an absorption profile of 56-70 days. Given the difference in profile for each
      suture and the physiologic wound healing process investigators question which would be more
      effective for wound healing.

      The purpose of the study:

        1. To compare poliglecaprone 25 and polyglactin 910 suture in Pfannenstiel incision closure
           for prevention of wound complication (SSI, hematoma, seroma, wound separation).

        2. To determine if risk factors for wound complication should guide the choice of suture
           used for closure of Pfannenstiel incision.

      Methods Patient enrollment will occur during their admission to labor and delivery. Patients
      will be approached if they meet the enrollment criteria. If they agree to participate in the
      trial a pre-randomized sequentially numbered, opaque, sealed envelope will be assigned to
      them and opened at the time of cesarean delivery which will assign the surgical suture to be
      used for skin closure.

      Inclusion criteria for the trial:

        1. Gestational age of 37 completed weeks or greater based on their estimated due date
           calculated from last menstrual period or early ultrasound.

        2. Scheduled cesarean delivery or...

        3. Non-emergent cesarean delivery

      Patients participating will be undergoing either:

        1. Scheduled cesarean delivery

        2. Non-emergent cesarean delivery

      Non-emergent cesarean delivery will be defined as an indicated cesarean delivery based on
      obstetrical criteria without significant fetal heart tracing abnormalities. This would
      include women diagnosed with a labor dystocia or arrest of labor, failed labor induction,
      fetal malpresentation in labor (i.e. breech presentation) or any other non-emergent
      indication for cesarean delivery in which there is no immediate danger to mother or fetus.

      The following exclusion criteria will be used:

        1. Urogenital tract infection within 2 weeks prior to surgery

        2. Chronic oral or injectable steroid use (> 2 weeks)

        3. Emergency cesarean delivery (need to deliver immediately due to a maternal or fetal
           indication)

        4. Vertical skin incision

        5. Participation in another research study

      The patients will be randomized after informed consent is obtained into two groups.

      Group 1: Incision closure with poliglecaprone 25 suture Group 2: Incision closure with
      polyglactin 910 suture

      Randomization for the study will be generated using www.randomization.com, in blocks of 6 and
      10 prior to the start of enrollment for the trial. Sequentially numbered, opaque, sealed
      envelopes will contain the surgical suture to be used for skin closure, poliglecaprone 25 or
      polyglactin 910.

      Surgical preparation will follow departmental protocol. Once the patient is randomized to a
      suture group the corresponding suture will be pulled and placed on the sterile field for use
      after completion of the cesarean in accordance to manufacturer's guidelines. Cesarean
      delivery will occur following the technique of the surgeon. Maternal demographics to be
      obtained will include BMI, gestational age, pre and postoperative day #1 complete blood
      count, estimated blood loss, type of preoperative skin preparation, surgical time from skin
      incision to closure, birth weight, Apgar scores, newborn outcome, indication for cesarean
      delivery, medical history and any antenatal complications, past surgical history,
      postoperative course, and intraoperative or postoperative complications. Wound complication
      will be defined as wound separation of ≥ 1 cm in length, hematoma or seroma (serous fluid
      collection or subcutaneous blood collection), and surgical site infection defined by the
      Center for Disease Control (CDC) guidelines. The primary outcome will include a composite
      finding of a wound complication in the 30 day period post-operatively.

      All patients will be followed until the routine postpartum visit occurs at 6-8 weeks
      following delivery with their primary prenatal care provider. Postpartum visit information
      will be extracted from the medical record. All patients will receive a follow up telephone
      call at post-operative day 30 or greater to monitor any post-operative complications as
      listed above.

      An alert notification will be placed in each patient's medical record that they are enrolled
      in this study and close monitoring and documentation of the cesarean incision is necessary.
      The definition of wound complication as listed in the first paragraph above will be included
      in the alert notification to standardize reporting for each patient.

      Recruitment Mechanisms Clinicians will ask patients during admission to labor and delivery
      after they meet enrollment criteria whether they are interested in the study. Consent will
      then be obtained by the research clinicians.

      Informed Consent Patient consent will occur on admission to the labor and delivery unit. The
      capacity of each patient to provide ethically adequate informed consent will be assessed by
      the PI or his designee. It is possible that patients will be enrolled during labor prior to
      cesarean section if not in significant pain although the majority of patients will be
      presenting for scheduled cesarean sections prior to labor. Consent will be obtained from
      women in active labor after labor analgesia has occurred. Emergency cesareans are excluded.
    

Intervention name(s): poliglecaprone 25 suture; polyglactin 910 suture
Intervention type(s): Device; Device
Intervention description(s): cesarean delivery incision closure with poliglecaprone 25 suture; cesarean delivery incision closure with polyglactin 910 suture
Other intervention name(s): MONOCRYL Suture (poliglecaprone 25 suture); VICRYL Suture (polyglactin 910 suture)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: wound complications