N/A
N=746
Cesarean Trial of Staples vs. Sutures
Cesarean Section · Wound Complications · Patient Satisfaction · Pain Measurement
Bottom Line
View on ClinicalTrials.gov: NCT01211600 ↗Enrolled (actual)
746
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Number of Participants With Wound Complications — 18; 40; 9; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Staples (Other); Suture (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Thomas Jefferson University
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Wound Complications |
18; 40; 9; 14; 2; 4 | — |
| SECONDARY Patient Scar Assessment Scale Scores for Evaluation of Cosmesis |
15; 20 | — |
| SECONDARY Patient Satisfaction With Closure Method and Scar Appearance |
9; 10; 9; 9 | — |
| SECONDARY Pain Perception |
3.5; 3.6; 4.3; 4.3; 4.3; 4.2 | — |
| SECONDARY Additional Provider Visits |
.9; 1.5; 2.7; 2.9; .8; 1.4 | — |
| SECONDARY Number of Participants With Primary Versus Repeat Cesarean |
109; 106; 126; 132; 71; 71 | — |
| SECONDARY Intraoperative Trial Details - Duration of Operation and Skin Closure |
58.5; 51; 15; 6 | — |
| SECONDARY Intraoperative Trial Details - Closure of Subcutaneous Tissue |
201; 202 | — |
| SECONDARY Length of Hospital Stay |
4.4; 4.5 | — |
| SECONDARY Number of Participants That Received Anticoagulation Within 24 Hours |
14; 17 | — |
| SECONDARY Number of Participants Diagnosed With Endomyometritis |
11; 7 | — |
| SECONDARY Change in Hemoglobin Pre-operatively to Post-operatively |
-1.8; -1.8 | — |
| SECONDARY Observer Evaluation of Cosmesis of the Cesarean Incision Based on Closure Method: Staples vs Sutures. |
12; 13 | — |
Summary
To determine whether the rate of wound complications differs based on method of closure of skin incision (staples vs. suture) after cesarean delivery.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01211600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.