Operative TimeNCT05112640
Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery
A study testing INSORB: subcuticular stapling device and Subcuticular monocryl suture manufactured by Ethicon in people with Operative Time and Wound Heal, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
Despite the high numbers of cesareans being performed, scientific evidence behind which surgical techniques are best remains uncertain. Our objective is to determine if subcuticular absorbable staples improve operative time and wound cosmetics. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Operative Time, Wound Heal
- What is being tested?
- INSORB: subcuticular stapling device and Subcuticular monocryl suture manufactured by Ethicon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2021to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-50 years of age
- Women ≥ 24 weeks viable gestation
- Will be undergoing cesarean delivery
Who cannot join
- Patient unwilling or unable to provide consent.
- No or very limited prenatal care or a non-resident patient who is unlikely to follow-up after delivery.
- Immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4 <200, or other
- Decision not to have skin closure (e.g. secondary wound closure, mesh closure)
- Current skin infection
- Coagulopathy
Show all 10Show fewer
- High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, tubal ligation, bowel or adnexal surgery)
- Incarcerated individuals
- Intraamniotic infection
- Subjects participating on other treatment trials or studies that would interfere with the current study's primary outcome.
Trial locations and contacts
1 site in 1 country.
United States1 site
John Sealy Hospital at University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery: A Randomized Control Trial
Despite the high numbers of cesareans being performed, scientific evidence behind which surgical techniques are best remains uncertain. Our objective is to determine if subcuticular absorbable staples improve operative time and wound cosmetics.
Read the detailed description
This will be an open-label randomized controlled clinical trial. Women undergoing cesarean delivery will be randomized to have either standard wound closure with Monocryl suture or absorbable subcuticular staples placed by INSORB skin stapling device. The INSORB under the skin stapling device is FDA approved but not currently used as standard of care at UTMB. We will exclude women with intraamniotic infection, immunosuppression, active skin infection, those unlikely to be followed-up after delivery, or unable to provide consent.
- Conditions
- Operative Time, Wound Heal
- Being tested
- INSORB: subcuticular stapling device, Subcuticular monocryl suture manufactured by Ethicon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSORB: subcuticular stapling deviceDevice
Under the skin stapling device that delivers absorbable staples
Subcuticular monocryl suture manufactured by EthiconDevice
Under the skin suture placed by hand
| Study group | Role | What they receive |
|---|---|---|
| Suture wound closure | Active comparator | Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon. Receives: Device: Subcuticular monocryl suture manufactured by Ethicon |
| Absorbable staple wound closure | Experimental | Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical. Receives: Device: INSORB: subcuticular stapling device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operating Time
Total time for the procedure
Measured: Start of surgery through end of skin closure in minutes
Secondary outcomes (6)
Wound Cosmesis
A digital photograph of the incision will be obtained on wound check visit POD 5-10 days. Each photograph will be evaluated by independent blinded research staff using the Stony Brook Scar Evaluation Scale.These scores are totaled to obtain the final score. The Stony Brook Scar Evaluation will score the scar from 0-5 where 5 shows significant healing.
Measured: Time of surgery through six weeks post partum
Number of Participants With Composite Wound Complication
Hematoma, seroma, dehiscence, breakdown of wound, wound infection, endometritis, sepsis, post part fevers
Measured: Time of surgery through six weeks post partum
Post Operative Pain
Analog pain scale ranging from 0-10. This is a standard question that nurses as during the post partum period while in the hospital and clinic/nursing visits. The numerical score will be recorded from the patient's chart.
A score of 0 means no pain, and 10 means the worst pain.
Measured: 5-10 days
Number of Adverse Events
Allergic reactions: anaphylaxis, angioedema, skin rashes, including Stevens Johnson and Toxic Epidermal Necrolysis
Measured: Time of surgery through six weeks post partum
Use of Resources
Postpartum clinic or emergency room visit within 30 days of delivery, need for imaging or other invasive procedures
Measured: Time of surgery through six weeks post partum
Skin Closure Time in Minutes
The average of minutes it takes for closure of the skin at time of surgery through weeks post partum.
Measured: Time of surgery through six weeks post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start16 Nov 2021
- Primary completion31 Dec 2023
- Study completion31 Mar 2024
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Operative TimeStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects who agree to participate in the study will be randomized to one of the two groups below in a 1/1 allocation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Cooper Companies
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112640
- Sponsor's protocol ID
- 21-0045
- Status last verified
- Jul 2024
- First submitted
- 13 Oct 2021
- Last updated
- 21 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Do not plan to share IPD.
Publications
Frishman 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 16334959Pineros-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 16566742Nitsche J, Howell C, Howell T. Skin closure with subcuticular absorbable staples after cesarean section is associated with decreased analgesic use. Arch Gynecol Obstet. 2012 Apr;285(4):979-83. doi: 10.1007/s00404-011-2121-5. Epub 2011 Oct 30.
PubMed 22037686Schrufer-Poland TL, Ruiz MP, Kassar S, Tomassian C, Algren SD, Yeast JD. Incidence of wound complications in cesarean deliveries following closure with absorbable subcuticular staples versus conventional skin closure techniques. Eur J Obstet Gynecol Reprod Biol. 2016 Nov;206:53-56. doi: 10.1016/j.ejogrb.2016.07.501. Epub 2016 Aug 3.
PubMed 27632411
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05112640
- Acronym / sponsor ID
- 21-0045
- Conditions
- Operative Time, Wound Heal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 117 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- Cooper Companies
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Posted 21 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite the high numbers of cesareans being performed, scientific evidence behind which surgical techniques are best remains uncertain. Our objective is to determine if subcuticular absorbable staples improve operative time and wound cosmetics.
Detailed description
This will be an open-label randomized controlled clinical trial. Women undergoing cesarean delivery will be randomized to have either standard wound closure with Monocryl suture or absorbable subcuticular staples placed by INSORB skin stapling device. The INSORB under the skin stapling device is FDA approved but not currently used as standard of care at UTMB. We will exclude women with intraamniotic infection, immunosuppression, active skin infection, those unlikely to be followed-up after delivery, or unable to provide consent.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects who agree to participate in the study will be randomized to one of the two groups below in a 1/1 allocation
| Arm | Type | Receives |
|---|---|---|
| Suture wound closure | Active comparator | Device: Subcuticular monocryl suture manufactured by EthiconAbsorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon. |
| Absorbable staple wound closure | Experimental | Device: INSORB: subcuticular stapling deviceStaples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-50 years of age
- Women ≥ 24 weeks viable gestation
- Will be undergoing cesarean delivery
Key exclusion criteria (10 listed)
- Patient unwilling or unable to provide consent.
- No or very limited prenatal care or a non-resident patient who is unlikely to follow-up after delivery.
- Immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4 <200, or other
- Decision not to have skin closure (e.g. secondary wound closure, mesh closure)
- Current skin infection
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: subcuticular stapling deviceUnder the skin stapling device that delivers absorbable staples | Device | Absorbable staple wound closure |
| Subcuticular monocryl suture manufactured by EthiconUnder the skin suture placed by hand | Device | Suture wound closure |
Primary outcome
Operating Time
Time frame: Start of surgery through end of skin closure in minutes
Total time for the procedure
6 secondary outcomes
Wound Cosmesis
Time frame: Time of surgery through six weeks post partum
Number of Participants With Composite Wound Complication
Time frame: Time of surgery through six weeks post partum
Post Operative Pain
Time frame: 5-10 days
Number of Adverse Events
Time frame: Time of surgery through six weeks post partum
Use of Resources
Time frame: Time of surgery through six weeks post partum
Skin Closure Time in Minutes
Time frame: Time of surgery through six weeks post partum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- 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 22037686Nitsche J, Howell C, Howell T. Skin closure with subcuticular absorbable staples after cesarean section is associated with decreased analgesic use. Arch Gynecol Obstet. 2012 Apr;285(4):979-83. doi: 10.1007/s00404-011-2121-5. Epub 2011 Oct 30.
- Background: PubMed 27632411Schrufer-Poland TL, Ruiz MP, Kassar S, Tomassian C, Algren SD, Yeast JD. Incidence of wound complications in cesarean deliveries following closure with absorbable subcuticular staples versus conventional skin closure techniques. Eur J Obstet Gynecol Reprod Biol. 2016 Nov;206:53-56. doi: 10.1016/j.ejogrb.2016.07.501. Epub 2016 Aug 3.
- Individual participant dataSharing planned: No. Do not plan to share IPD.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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: subcuticular stapling device and Subcuticular monocryl suture manufactured by Ethicon in people with Operative Time and Wound Heal, run by The University of Texas Medical Branch, Galveston 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 3 inclusion and 10 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 21 Aug 2024. 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?
Yes. Results are posted in the registry (first posted 21 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Operating Time (time frame: Start of surgery through end of skin closure in minutes). 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 NCT05112640, which also lists 7 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 21 Aug 2024.