Comparison of Staples Versus Prolene Suture for Skin Closure at Cesarean Delivery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Staples Versus Nonabsorbable Subcuticular (Prolene) Suture for Skin Closure in Cesarean Deliveries: A Randomized Study

Conditions
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Pregnancy, Cesarean Section

Intervention / Treatment
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* Procedure: Staples
* Procedure: Prolene non-absorbable sutures
* Procedure: Absorbable Sutures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women undergoing primary or repeat cesarean section Maternal age greater than or equal to 18 years of age Gestational age greater than or equal to 34 weeks Elective and non-elective cesarean section Exclusion Criteria: Type 1 or Type 2 diabetes BMI greater than 35 Pre-operative diagnosis of chorioamnionitis History of drug or alcohol abuse Contraindication to NSAIDs Chronic pain diagnosis Narcotic use prior to pregnancy Maternal age less than 18 years of age General anesthesia Chorioamnionitis, clinical suspicion of chorioamnionitis, or risk factors for chorioamnionitis (membrane rupture greater than 18 hours, GBS positive status) Vertical skin incision

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Staples<br>Use of staples for skin closure at cesarean section | Procedure: Staples<br>* Staples for closure of cesarean section skin incision<br>* Other names: Reflex one skin stapler 35 wide. Manufactured by Conmed;|
| Active Comparator: Prolene non-absorbable sutures<br>Use of Prolene non-absorbable sutures for skin closure at cesarean section | Procedure: Prolene non-absorbable sutures<br>* Prolene non-absorbable sutures for closure of cesarean skin incision<br>* Other names: Prolene 2-0 18 inch on FS needle. Manufactured by Ethicon;|
| Active Comparator: Absorbable sutures<br>Use of absorbable sutures for skin closure at cesarean section; monocryl or vicryl. | Procedure: Absorbable Sutures<br>* Absorbable sutures for closure of cesarean skin incision<br>* Other names: Monocryl or Vicryl. Manufactured by Ethicon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Pain on a Scale During the Post-operative Hospitalization Period | Pain level on a Mosby visual analog pain scale of 1 (no pain) to 10 (worst pain) | Post-operative day 3 or 4. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Pain on a Scale at 6 Weeks Postpartum | Pain level on a scale (Mosby visual analog pain scale) of 1 (no pain) to 10 (worst pain). | Post-operative week 6 | 
| Count of Participants With Wound Complications | Wound complications include conditions like infection, seroma/hematoma and dehiscence | Post-operative week 6 | 
| Level of Patient Satisfaction to the Wound Appearance | Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied) | Post-operative day 3 or 4 | 
| Level of Patient Satisfaction to the Wound Appearance at 6 Weeks Postpartum | Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied) | Post-operative week 6 | 
| Time From Skin Incision to the Skin Closure | Measured in minutes | Day of cesarean delivery (up to 8 hours) | 
| Time Needed for the Suture Removal | Measured in seconds | Post-operative day 3 or 4 | 
| Level of Patient's Satisfaction to the Cosmesis of the Wound | Measured on a scale of 0 (very unsatisfied to the cosmesis) to 10 (very satisfied to the cosmesis) | Post-operative week 6 | 
| Level of Patient's Overall Patient Satisfaction to the Type of Closure | Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied) | Post-operative day 1 | 
| Level of Patient's Overall Patient Satisfaction to the Type of Closure | Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied) | Post-operative day 3 or 4 | 
| Level of Patient's Overall Patient Satisfaction to the Type of Closure | Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied) | Post-operative week 6 |