PregnancyNCT07167199
Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery
A study testing Subcuticular monocryl suture and Subcuticular absorbable staple using Insorb device in people with Pregnancy, run by Inova Health Care Services 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 only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Subcuticular monocryl suture and Subcuticular absorbable staple using Insorb device
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- 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. Contact the study team or a site near you to ask about taking part.
United States1 site
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
Antonio Saad, MD, 706-776-6040, antonio.saad@inova.org
Michelle L Cassidy, PhD, RN, (703) 776-4600, michelle.cassidy@inova.org
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 Inova. 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
- Pregnancy
- Being tested
- Subcuticular monocryl suture, Subcuticular absorbable staple using Insorb device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcuticular monocryl sutureProcedure or surgery
Under the skin suture placed by hand
Subcuticular absorbable staple using Insorb deviceDevice
Under the skin stapling device that delivers absorbable staples
| Study group | Role | What they receive |
|---|---|---|
| Suture wound closure | Active comparator | Absorbable Moncryl sutures for closure of cesarean skin incision Receives: Procedure: Subcuticular monocryl suture |
| Absorbable staple wound closure | Experimental | Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by CooperSurgical. Receives: Device: Subcuticular absorbable staple using Insorb 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: Time from the start of surgery through end of skin closure up to 8 hours
Secondary outcomes (2)
Wound Cosmesis
A digital photograph of the incision will be obtained on wound check visit POD 5-10 days and 4-6 weeks post partum. 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: Up to 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: up to 3 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Nov 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- 237 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Saad, MD, Principal investigator, Inova Fairfax Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167199
- Sponsor's protocol ID
- INOVA-2024-333
- Status last verified
- Dec 2025
- First submitted
- 26 Aug 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. 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
- NCT07167199
- Acronym / sponsor ID
- INOVA-2024-333
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 237 participants (estimated)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 11 Sep 2025 (actual)
- 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.
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 Inova. 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 | Procedure: Subcuticular monocryl sutureAbsorbable Moncryl sutures for closure of cesarean skin incision |
| Absorbable staple wound closure | Experimental | Device: Subcuticular absorbable staple using Insorb deviceStaples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by CooperSurgical. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not 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 |
|---|---|---|
| Subcuticular monocryl sutureUnder the skin suture placed by hand | Procedure or surgery | Suture wound closure |
| Subcuticular absorbable staple using Insorb deviceUnder the skin stapling device that delivers absorbable staples | Device | Absorbable staple wound closure |
Primary outcome
Operating time
Time frame: Time from the start of surgery through end of skin closure up to 8 hours
Total time for the procedure
2 secondary outcomes
Wound Cosmesis
Time frame: Up to six weeks post partum
Post Operative Pain
Time frame: up to 3 days post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
Antonio Saad, MD principal investigator
Inova Fairfax Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcuticular monocryl suture and Subcuticular absorbable staple using Insorb device in people with Pregnancy, run by Inova Health Care Services 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: opening soon, as of the sponsor's last update on 30 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Saad, MD ((703) 779-6040, antonio.saad@inova.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operating time (time frame: Time from the start of surgery through end of skin closure up to 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2026.