Comparison of Staples Versus Prolene Suture for Skin Closure at Cesarean Delivery
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 3/6/2019 |
| Start Date: | January 2012 |
| End Date: | May 4, 2013 |
Comparison of Staples Versus Nonabsorbable Subcuticular (Prolene) Suture for Skin Closure in Cesarean Deliveries: A Randomized Study
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.
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.
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.
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.
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
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