Comparison of Staples Versus Prolene Suture for Skin Closure at Cesarean Delivery
Condition: Pregnancy; Cesarean Section
Study type: Interventional

Summary: 
      Currently different materials are used to close the skin after a cesarean delivery, including
      absorbable suture, non-absorbable suture and staples. It is not known what is the best choice
      of material to close the skin after a cesarean section, but commonly staples or dissolvable
      suture is used. Recently plastic surgeons have found that non-dissolvable suture may have a
      better cosmetic outcome than staples. The investigators hope to learn if there is a
      difference in pain both at suture/staple removal and 6 weeks postoperatively between Prolene
      suture, Absorbable suture (monocryl or vicryl) or staples. The investigators also plan to
      look for differences in wound complications and patient satisfaction, as well as operating
      and removal times. This knowledge will be important in helping practitioners choose the
      closure technique at cesarean delivery.
    

Detailed description: 
      Patients who meet inclusion criteria will be approached upon admission to Labor and Delivery.
      A study staff member will describe the study and offer participation. If a patient agrees to
      participate, she will sign research protocol and HIPAA consent forms and receive a copy of
      these forms. The patient's chart will be flagged, indicating that she is a study participant.
      The patient's prenatal care and labor and delivery will be managed by her physician per
      standard of care at the physician's discretion, including routine surgical preparation and
      procedures.

      When a participating patient is scheduled for a cesarean section, she will be randomized to
      Arm 1 (Staples) or Arm 2 (Prolene) or Arm 3 (Monocryl or Vicryl absorbable suture). She will
      be treated as per standard of care and her cesarean section performed per physician
      discretion. After the closure of the fascial layer, the surgeons will follow the same
      protocol for each study participant, including wound irrigation with warm sterile saline and
      reapproximation of the subcutaneous layer if greater than 2.0 cm in depth (per standard of
      care). The patient in Arm 1 will have skin closure with staples. The patient in Arm 2 will
      have skin closure with 2-0 Prolene in a subcuticular fashion. The patient in Arm 3 will have
      skin closure with monocryl or vicryl in the standard fashion. Patients in Arms 1 and 2 will
      have their closure material removed at the physician's discretion per the standard of care at
      post-operative day 3 or 4.

      Pain level will be assessed on the first and third or fourth day after surgery and again at
      six weeks.
    

Intervention name(s): Staples; Prolene non-absorbable sutures; Absorbable Sutures
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Staples for closure of cesarean section skin incision; Prolene non-absorbable sutures for closure of cesarean skin incision; Absorbable sutures for closure of cesarean skin incision
Other intervention name(s): Reflex one skin stapler 35 wide. Manufactured by Conmed; Prolene 2-0 18 inch on FS needle. Manufactured by Ethicon; Monocryl or Vicryl. Manufactured by Ethicon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment