Postoperative Pain and Skin Closure Methods After Cesarean Section
| Status: | Terminated |
|---|---|
| Conditions: | Post-Surgical Pain, Women's Studies |
| Therapuetic Areas: | Musculoskeletal, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 44 |
| Updated: | 10/26/2017 |
| Start Date: | January 2012 |
| End Date: | January 1, 2016 |
Post-Operative Pain and Skin Closure Methods After Cesarean Section
The study is looking at women undergoing cesarean section delivery of their baby. The purpose
of this research study is to determine what type of skin closure after cesarean section helps
decrease pain level the most and improves the appearance of the incision site.
The study hypothesis is to determine if skin closure with absorbable subcuticular staples
leads to improved cosmesis and/or decreased post-operative pain.
Participants in the study will already be scheduled for a cesarean section for delivery of
their baby. They will be randomized into one of three groups, 1) Insorb (absorbable
subcuticular stapes), 2) Vicryl suture or 3) Monocryl suture for the skin closure of their
cesarean section. Information that will be recorded includes amount of pain medication usage
while in the hospital after cesarean section, daily patient rated pain score until discharge
from hospital, pain score 6 weeks after surgery and cesarean section cosmetic scar 6 weeks
after surgery.
of this research study is to determine what type of skin closure after cesarean section helps
decrease pain level the most and improves the appearance of the incision site.
The study hypothesis is to determine if skin closure with absorbable subcuticular staples
leads to improved cosmesis and/or decreased post-operative pain.
Participants in the study will already be scheduled for a cesarean section for delivery of
their baby. They will be randomized into one of three groups, 1) Insorb (absorbable
subcuticular stapes), 2) Vicryl suture or 3) Monocryl suture for the skin closure of their
cesarean section. Information that will be recorded includes amount of pain medication usage
while in the hospital after cesarean section, daily patient rated pain score until discharge
from hospital, pain score 6 weeks after surgery and cesarean section cosmetic scar 6 weeks
after surgery.
Cesarean delivery is the most common surgical procedure performed in the United States, with
over 1 million procedures performed per year. Based on recent Centers for Disease Control
National Vital Statistics Report 32.3% of all births in the United States were via cesarean
delivery, marking the twelfth consecutive annual increase in the cesarean delivery rate.
Given the high numbers of cesarean deliveries being performed today, there has been interest
in optimizing surgical techniques. Several recent reviews have summarized the evidence for
various steps of cesarean delivery, but surprisingly in many cases there is little scientific
evidence on which to base the choice of surgical technique.
The topic of skin closure after cesarean delivery is an area that has been the focus of
several randomized control trials. The trials compared surgical steel staples to subcuticular
suture of various materials focusing on differences in post-operative pain, infection rates,
and scar cosmesis. Cosmesis has been investigated in all three Randomized Clinical Trials and
none have found differences between surgical steel staples and subcuticular suture. Infection
rate has been studied in a single observational study which found a higher infection rate in
those patients whose skin was closed with surgical steel staples compared to suture. Studies
of post-operative pain and skin closure technique have been contradictory. The earliest
Randomized clinical trial to investigate skin closure and post-operative pain was done by
Frishman et al (5) and found that subjective self-assessment of pain was better at hospital
discharge and 6 weeks post-operatively in patients when subcuticular suture rather than
surgical steel staples were used. A subsequent Randomized clinical trial reported the
opposite result with less pain 6 weeks post-operatively when surgical steel staples were
used. This discrepancy may, in part, be due to the different suture material used in the two
trials. The study by Frishman et al which showed a benefit of subcuticular suture utilized
used polyglycolic acid (Vicryl suture or Insorb staples); whereas, the study by Rousseau et
al used polyglecaprone (Monocryl suture). To date direct comparison of skin closure at the
time of cesarean with these two suture materials has not been performed.
Recently, a new technology for skin closure has been introduced that employs absorbable
material, polylactic and polyglycolic acid, in subcuticular staples. In animal models this
method of skin closure has shown less histological inflammation and fewer wound infections
than either surgical steel staples or subcuticular suture. Unfortunately, little is known
about how this skin closure technique compares to the other more established techniques after
cesarean delivery in humans. However, a retrospective analysis comparing subcuticular
absorbable staples with surgical steel staples revealed an association between subcuticular
absorbable staples and decreased in-hospital analgesic use. The current study is a
prospective randomized trial that investigates four cesarean skin closure techniques—surgical
steel staples, subcuticular polyglycolic acid suture (Vicryl), subcuticular, polyglecaprone
suture (Monocryl), and absorbable subcuticular polyglycolic acid staples—to determine if one
is associated with improved cosmesis or a decrease in post-operative pain.
over 1 million procedures performed per year. Based on recent Centers for Disease Control
National Vital Statistics Report 32.3% of all births in the United States were via cesarean
delivery, marking the twelfth consecutive annual increase in the cesarean delivery rate.
Given the high numbers of cesarean deliveries being performed today, there has been interest
in optimizing surgical techniques. Several recent reviews have summarized the evidence for
various steps of cesarean delivery, but surprisingly in many cases there is little scientific
evidence on which to base the choice of surgical technique.
The topic of skin closure after cesarean delivery is an area that has been the focus of
several randomized control trials. The trials compared surgical steel staples to subcuticular
suture of various materials focusing on differences in post-operative pain, infection rates,
and scar cosmesis. Cosmesis has been investigated in all three Randomized Clinical Trials and
none have found differences between surgical steel staples and subcuticular suture. Infection
rate has been studied in a single observational study which found a higher infection rate in
those patients whose skin was closed with surgical steel staples compared to suture. Studies
of post-operative pain and skin closure technique have been contradictory. The earliest
Randomized clinical trial to investigate skin closure and post-operative pain was done by
Frishman et al (5) and found that subjective self-assessment of pain was better at hospital
discharge and 6 weeks post-operatively in patients when subcuticular suture rather than
surgical steel staples were used. A subsequent Randomized clinical trial reported the
opposite result with less pain 6 weeks post-operatively when surgical steel staples were
used. This discrepancy may, in part, be due to the different suture material used in the two
trials. The study by Frishman et al which showed a benefit of subcuticular suture utilized
used polyglycolic acid (Vicryl suture or Insorb staples); whereas, the study by Rousseau et
al used polyglecaprone (Monocryl suture). To date direct comparison of skin closure at the
time of cesarean with these two suture materials has not been performed.
Recently, a new technology for skin closure has been introduced that employs absorbable
material, polylactic and polyglycolic acid, in subcuticular staples. In animal models this
method of skin closure has shown less histological inflammation and fewer wound infections
than either surgical steel staples or subcuticular suture. Unfortunately, little is known
about how this skin closure technique compares to the other more established techniques after
cesarean delivery in humans. However, a retrospective analysis comparing subcuticular
absorbable staples with surgical steel staples revealed an association between subcuticular
absorbable staples and decreased in-hospital analgesic use. The current study is a
prospective randomized trial that investigates four cesarean skin closure techniques—surgical
steel staples, subcuticular polyglycolic acid suture (Vicryl), subcuticular, polyglecaprone
suture (Monocryl), and absorbable subcuticular polyglycolic acid staples—to determine if one
is associated with improved cosmesis or a decrease in post-operative pain.
Inclusion Criteria:
- Age 18-44
- Any race
- Any parity
- Scheduled Cesarean Section
- Neuraxial analgesia
Exclusion Criteria:
- Diabetes Mellitus
- Maternal Connective Tissue Disorder
- Maternal Steroid Use
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