Cesarean Trial of Staples vs. Sutures

Study Overview
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Brief Summary
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To determine whether the rate of wound complications differs based on method of closure of skin incision (staples vs. suture) after cesarean delivery.

Detailed Description
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Despite this large number of cesareans performed annually, there is a paucity of data to suggest which technique is superior for closure of the skin incision with regards to wound complications, including wound separation and infection. As the morbidity associated with a cesarean delivery is usually related to wound complications, especially infection, we feel that it is important to examine this outcome by comparing the current skin closure techniques: staples versus suture.

Official Title
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Cesarean Randomized Control Trial Of Sutures vs. Staples (CROSS)

Conditions
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Cesarean Section, Wound Complications, Patient Satisfaction, Pain Measurement

Intervention / Treatment
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* Other: Staples
* Other: Suture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women undergoing cesarean delivery for pregnancy greater than 23 weeks gestation. Exclusion Criteria: Poorly controlled diabetes (defined as ≥ 50% of fasting or 2 hour postprandial glucose levels > 95 and 120 respectively within the week prior to delivery), Vertical skin incisions Chronic steroid use Active lupus flare HIV/AIDS Current treatment for cancer or a history of radiation to the abdomen/pelvis Current treatment with immunosuppressant medications secondary to history of transplantation Emergency cesarean(precluding informed consent prior to surgery) Lack of access to a phone Allergy to suture or staple material
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Staples<br>Interrupted Ethicon Staples | Other: Staples<br>* Interrupted Ethicon Staples<br>* Other names: Closure Technique;|
| Active Comparator: Suture<br>Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle) | Other: Suture<br>* Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)<br>* Other names: Closure Technique;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Wound Complications | The primary outcome is to evaluate the rate of wound complications for patients undergoing cesarean whose skin incision is closed with staples versus with suture. Wound complications included infection, hematoma, seroma, and separation and readmission for wound complication. | Within 6 weeks of postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Scar Assessment Scale Scores for Evaluation of Cosmesis | Patient evaluation of cosmesis of the cesarean incision based on closure method: staples vs sutures. Surgical scars were evaluated using Patient Scar Assessment Scale (PSAS). The PSAS evaluates six items: pain, itchiness, color, stiffness, thickness, and irregularity. Each item is scored on a 10-point scale comparing the patient's skin to normal skin, in which one represents normal skin. The score is summed, range 6-60. Lower scores indicate closer resemblance to normal skin and are superior. | Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks. | 
| Patient Satisfaction With Closure Method and Scar Appearance | Whether the patient's satisfaction with the incision differed based on closure method (staples vs sutures) using 10-point Likert scale on which 1 is completely dissatisfied and 10 is completely satisfied. | Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks. | 
| Pain Perception | Whether the patient's perception of pain associated with the incision differed based on closure method (staples vs sutures). Patients were asked to rate pain on a scale from 0 (no pain) to 10 (extreme pain) using a visual graph of facial expressions. | Immediately postpartum to time of discharge, which is typically 3-4 days post-cesarean | 
| Additional Provider Visits | Mean number of visits per participant (All wound visits, number of visits for women who were diagnosed with wound complications, number of visits for women who were not diagnosed with a wound complication). | Within 6 weeks postpartum | 
| Number of Participants With Primary Versus Repeat Cesarean | Randomization stratum - BMI (over/under 30) and Cesarean (primary or repeat) | At randomization. | 
| Intraoperative Trial Details - Duration of Operation and Skin Closure | Duration of operation: skin incision to skin closure Duration of skin closure: fascial closure to skin closure | Time of Cesarean | 
| Intraoperative Trial Details - Closure of Subcutaneous Tissue | Number of participants requiring subcutaneous tissue closure | Time of Cesarean | 
| Length of Hospital Stay | Length of hospital stay (days) | Immediate postpartum. | 
| Number of Participants That Received Anticoagulation Within 24 Hours | Number of participants that received anticoagulation within 24 hours of procedure (preoperatively or postoperatively) | Within 24 hours postpartum. | 
| Number of Participants Diagnosed With Endomyometritis | Number of participants diagnosed with endomyometritis requiring antibiotics | Immediate postpartum. | 
| Change in Hemoglobin Pre-operatively to Post-operatively | Median change in hemoglobin from preoperative value (g/dL) to post-operatively. | Up to 72 hours before and 24 hours after cesarean. | 
| Observer Evaluation of Cosmesis of the Cesarean Incision Based on Closure Method: Staples vs Sutures. | Surgical scars were evaluated using Observer Scar Assessment Scale (OSAS). The OSAS evaluates five items: vascularity, pigmentation, thickness, relief, and pliability. Each item is scored on a 10-point scale comparing the patient's skin to normal skin, in which one represents normal skin. The score is summed, range 5-50. Lower scores indicate closer resemblance to normal skin and are superior. | Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Staples, Sutures, Wound infections, Cosmesis, Aesthetic appearance of skin incision