PregnancySkinNCT02028000
Postoperative Pain and Skin Closure Methods After Cesarean Section
A study testing Insorb staples skin closure, Monocryl skin closure and Vicryl skin closure in people with Pregnancy, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Insorb staples skin closure, Monocryl skin closure and Vicryl skin closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to 1 Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-44
- Any race
- Any parity
- Scheduled Cesarean Section
- Neuraxial analgesia
Who cannot join
- Diabetes Mellitus
- Maternal Connective Tissue Disorder
- Maternal Steroid Use
Trial locations and contacts
1 site in 1 country.
United States1 site
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Pregnancy
- Being tested
- Insorb staples skin closure, Monocryl skin closure, Vicryl skin closure
- Keywords
- Pregnancy, Pregnant, Cesarean Section Delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insorb staples skin closureProcedure or surgery
Patients will be randomized to Insorb staples skin closure and compared to Monocryl and Vicryl group.
Monocryl skin closureProcedure or surgery
Patients will be randomized to Monocryl skin closure and compared to Insorb skin closure and Vicryl skin closure.
Vicryl skin closureProcedure or surgery
Patients will be randomized to Vicryl skin closure and compared to Insorb and Monocryl skin closure groups.
| Study group | Role | What they receive |
|---|---|---|
| INSORB staples skin closure | Active comparator | Women undergoing cesarean section delivery will have skin closure with INSORB staples. Receives: Procedure: Monocryl skin closure; Procedure: Vicryl skin closure |
| Monocryl skin closure | Active comparator | Women undergoing cesarean section delivery will have skin closure with Monocryl. Receives: Procedure: Insorb staples skin closure; Procedure: Vicryl skin closure |
| Vicryl skin closure | Active comparator | Women undergoing cesarean section delivery will have Vicryl skin closure Receives: Procedure: Insorb staples skin closure; Procedure: Monocryl skin closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intravenous and analgesic use.
Record the amount of in hospital intravenous and oral analgesic use.
Measured: Admission for delivery of baby by cesarean section to expected postpartum average of 6 weeks
Daily subjective pain score while hospitalized
Daily patient rated subjective pain score (0-10 based on visual analog scale) until dismissal from the hospital will be recorded.
Measured: Hospital admission for cesarean section delivery
6 week postoperative subjective pain score
Patient rated subjective pain score 6 weeks postoperatively will be recorded.
Measured: After cesarean section delivery at the 6 week postpartum visit
Scar cosmetic score 6 weeks post-operatively.
6 weeks post-operative scar cosmetic score will be recorded.
Measured: 6 weeks post-operatively after cesarean section
Secondary outcomes (2)
Wound complications
Wound complications (infection, separation, or seroma)
Measured: Time of cesarean section until 6 weeks postpartum visit
Length of hospital stay
Length of hospital stay
Measured: C/S admission to discharge time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startJan 2012
- Primary completion1 Jan 2016
- Study completion1 Jan 2016
Why it stopped: Insufficient data to continue. Study will not resume.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua Nitsche, MD, PhD, Principal investigator, Wake Forest Baptist School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028000
- Sponsor's protocol ID
- 17928
- Acronym
- Skin
- Status last verified
- Oct 2017
- First submitted
- 9 Oct 2012
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Walsh CA. Evidence-based cesarean technique. Curr Opin Obstet Gynecol. 2010 Apr;22(2):110-5. doi: 10.1097/GCO.0b013e3283372327.
PubMed 20216417Johnson A, Young D, Reilly J. Caesarean section surgical site infection surveillance. J Hosp Infect. 2006 Sep;64(1):30-5. doi: 10.1016/j.jhin.2006.03.020. Epub 2006 Jul 5.
PubMed 16822582Pineros-Fernandez A, Salopek LS, Rodeheaver PF, Drake DB, Edlich RF, Rodeheaver GT. A revolutionary advance in skin closure compared to current methods. J Long Term Eff Med Implants. 2006;16(1):19-27. doi: 10.1615/jlongtermeffmedimplants.v16.i1.30.
PubMed 16566742Hamilton BE, Martin JA, Ventura SJ. Births: preliminary data for 2009. Natl Vital Stat Rep. 2010 Dec;59(3):1-19.
PubMed 25073731Altman AD, Allen VM, McNeil SA, Dempster J. Pfannenstiel incision closure: a review of current skin closure techniques. J Obstet Gynaecol Can. 2009 Jun;31(6):514-520. doi: 10.1016/S1701-2163(16)34213-X.
PubMed 19646316Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery. Am J Obstet Gynecol. 2005 Nov;193(5):1607-17. doi: 10.1016/j.ajog.2005.03.063.
PubMed 16260200Frishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30.
PubMed 9350017Gaertner I, Burkhardt T, Beinder E. Scar appearance of different skin and subcutaneous tissue closure techniques in caesarean section: a randomized study. Eur J Obstet Gynecol Reprod Biol. 2008 May;138(1):29-33. doi: 10.1016/j.ejogrb.2007.07.003. Epub 2007 Sep 6.
PubMed 17825472Rousseau JA, Girard K, Turcot-Lemay L, Thomas N. A randomized study comparing skin closure in cesarean sections: staples vs subcuticular sutures. Am J Obstet Gynecol. 2009 Mar;200(3):265.e1-4. doi: 10.1016/j.ajog.2009.01.019.
PubMed 19254586Fick JL, Novo RE, Kirchhof N. Comparison of gross and histologic tissue responses of skin incisions closed by use of absorbable subcuticular staples, cutaneous metal staples, and polyglactin 910 suture in pigs. Am J Vet Res. 2005 Nov;66(11):1975-84. doi: 10.2460/ajvr.2005.66.1975.
PubMed 16334959Singer AJ, Arora B, Dagum A, Valentine S, Hollander JE. Development and validation of a novel scar evaluation scale. Plast Reconstr Surg. 2007 Dec;120(7):1892-1897. doi: 10.1097/01.prs.0000287275.15511.10.
PubMed 18090752
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Pain and Skin Closure Methods After Cesarean Section
- ClinicalTrials.gov ID
- NCT02028000
- Acronym / sponsor ID
- Skin / 17928
- Conditions
- Pregnancy
- Keywords
- Pregnancy, Pregnant, Cesarean Section Delivery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient data to continue. Study will not resume.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Jan 2016 (actual)
- First posted
- 6 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| INSORB staples skin closure | Active comparator | Procedure: Monocryl skin closure, Procedure: Vicryl skin closureWomen undergoing cesarean section delivery will have skin closure with INSORB staples. |
| Monocryl skin closure | Active comparator | Procedure: Insorb staples skin closure, Procedure: Vicryl skin closureWomen undergoing cesarean section delivery will have skin closure with Monocryl. |
| Vicryl skin closure | Active comparator | Procedure: Insorb staples skin closure, Procedure: Monocryl skin closureWomen undergoing cesarean section delivery will have Vicryl skin closure |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-44
- Any race
- Any parity
- Scheduled Cesarean Section
- Neuraxial analgesia
Key exclusion criteria (3 listed)
- Diabetes Mellitus
- Maternal Connective Tissue Disorder
- Maternal Steroid Use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insorb staples skin closurePatients will be randomized to Insorb staples skin closure and compared to Monocryl and Vicryl group. | Procedure or surgery | Monocryl skin closure, Vicryl skin closure |
| Monocryl skin closurePatients will be randomized to Monocryl skin closure and compared to Insorb skin closure and Vicryl skin closure. | Procedure or surgery | INSORB staples skin closure, Vicryl skin closure |
| Vicryl skin closurePatients will be randomized to Vicryl skin closure and compared to Insorb and Monocryl skin closure groups. | Procedure or surgery | INSORB staples skin closure, Monocryl skin closure |
Primary outcome
Intravenous and analgesic use.
Time frame: Admission for delivery of baby by cesarean section to expected postpartum average of 6 weeks
Record the amount of in hospital intravenous and oral analgesic use.
Daily subjective pain score while hospitalized
Time frame: Hospital admission for cesarean section delivery
Daily patient rated subjective pain score (0-10 based on visual analog scale) until dismissal from the hospital will be recorded.
6 week postoperative subjective pain score
Time frame: After cesarean section delivery at the 6 week postpartum visit
Patient rated subjective pain score 6 weeks postoperatively will be recorded.
Scar cosmetic score 6 weeks post-operatively.
Time frame: 6 weeks post-operatively after cesarean section
6 weeks post-operative scar cosmetic score will be recorded.
2 secondary outcomes
Wound complications
Time frame: Time of cesarean section until 6 weeks postpartum visit
Length of hospital stay
Time frame: C/S admission to discharge time
Results and safety
The study was stopped early (reason given: Insufficient data to continue. Study will not resume.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
- Background: PubMed 20216417Walsh CA. Evidence-based cesarean technique. Curr Opin Obstet Gynecol. 2010 Apr;22(2):110-5. doi: 10.1097/GCO.0b013e3283372327.
- Background: PubMed 16822582Johnson A, Young D, Reilly J. Caesarean section surgical site infection surveillance. J Hosp Infect. 2006 Sep;64(1):30-5. doi: 10.1016/j.jhin.2006.03.020. Epub 2006 Jul 5.
- Background: PubMed 16566742Pineros-Fernandez A, Salopek LS, Rodeheaver PF, Drake DB, Edlich RF, Rodeheaver GT. A revolutionary advance in skin closure compared to current methods. J Long Term Eff Med Implants. 2006;16(1):19-27. doi: 10.1615/jlongtermeffmedimplants.v16.i1.30.
- Background: PubMed 25073731Hamilton BE, Martin JA, Ventura SJ. Births: preliminary data for 2009. Natl Vital Stat Rep. 2010 Dec;59(3):1-19.
- Results publication: PubMed 19646316Altman AD, Allen VM, McNeil SA, Dempster J. Pfannenstiel incision closure: a review of current skin closure techniques. J Obstet Gynaecol Can. 2009 Jun;31(6):514-520. doi: 10.1016/S1701-2163(16)34213-X.
- Results publication: PubMed 16260200Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery. Am J Obstet Gynecol. 2005 Nov;193(5):1607-17. doi: 10.1016/j.ajog.2005.03.063.
- Results publication: PubMed 9350017Frishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30.
- Results publication: PubMed 17825472Gaertner I, Burkhardt T, Beinder E. Scar appearance of different skin and subcutaneous tissue closure techniques in caesarean section: a randomized study. Eur J Obstet Gynecol Reprod Biol. 2008 May;138(1):29-33. doi: 10.1016/j.ejogrb.2007.07.003. Epub 2007 Sep 6.
- Results publication: PubMed 19254586Rousseau JA, Girard K, Turcot-Lemay L, Thomas N. A randomized study comparing skin closure in cesarean sections: staples vs subcuticular sutures. Am J Obstet Gynecol. 2009 Mar;200(3):265.e1-4. doi: 10.1016/j.ajog.2009.01.019.
- Results publication: PubMed 16334959Fick JL, Novo RE, Kirchhof N. Comparison of gross and histologic tissue responses of skin incisions closed by use of absorbable subcuticular staples, cutaneous metal staples, and polyglactin 910 suture in pigs. Am J Vet Res. 2005 Nov;66(11):1975-84. doi: 10.2460/ajvr.2005.66.1975.
- Results publication: PubMed 18090752Singer AJ, Arora B, Dagum A, Valentine S, Hollander JE. Development and validation of a novel scar evaluation scale. Plast Reconstr Surg. 2007 Dec;120(7):1892-1897. doi: 10.1097/01.prs.0000287275.15511.10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Nitsche, MD, PhD principal investigator
Wake Forest Baptist School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insorb staples skin closure, Monocryl skin closure and Vicryl skin closure in people with Pregnancy, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient data to continue. Study will not resume.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intravenous and analgesic use. (time frame: Admission for delivery of baby by cesarean section to expected postpartum average of 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02028000, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2017.