WoundSVSNCT01008449
Staples Versus Suture for Cesarean Wound Closure
A study testing Surgical staples and Absorbable Surgical Suture in people with Wound, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The objective of this randomized controlled trial is to compare wound morbidity (including disruption and infection) in surgical staples versus absorbable subcuticular suture for wound closure in cesarean deliveries. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Wound
- What is being tested?
- Surgical staples and Absorbable Surgical Suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Feb 2011
- 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- cesarean delivery
Who cannot join
- chronic use of immunosuppressive agents ( e.g.po steroids > 2 weeks)
- significant immune compromising disease (e.g. AIDS, CD4<200)
- contraindication to standard post operative pain management (acetaminophen, ibuprofen, oxycodone)
- refusal or inability to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Staples vs. Absorbable Subcuticular Suture for Wound Closure of Cesarean Deliveries
The objective of this randomized controlled trial is to compare wound morbidity (including disruption and infection) in surgical staples versus absorbable subcuticular suture for wound closure in cesarean deliveries.
Read the detailed description
Cesarean delivery (CD) is a common surgical procedure with over 1 million performed annually in the United States. The rate of CD is steadily increasing. In 2006, an estimated 31.1% of U.S. births were by CD. Approximately two thirds of these are primary procedures and 90% of CD will later undergo a repeat cesarean delivery. The rise in CD has been attributed to changes in physician and patient expectations, attitudes about risk, and changes in clinical practice. These include decreased vaginal birth after cesarean delivery (VBAC), breech vaginal deliveries, and operative vaginal deliveries as well as an increase in maternal request, failed induction of labor, and elective repeat CD. The CD rate is expected to rise as high as 40-50% in the next decade if the increasing trend continues unabated.
Despite the large number of CD performed, there is no agreed standard for skin closure. The most commonly used materials are surgical staples and absorbable subcuticular suture. Staples have a clear benefit in decreasing operating time. In theory, staples also have a decreased chance of bacterial migration into the wound, decreased tension at the incision edges, and less damage to capillaries in the subcuticular layer of skin than absorbable subcuticular suture. However, some argue that staples are more painful and have a worse cosmetic appearance. This is especially the case for staples that remain in place longer than recommended and leave "track marks." Staples are also less visually appealing to patients.
The Cochrane Collaboration identified one randomized controlled trial (RCT) that addressed skin closure for CD (Alderice, 2003). This study included 66 women and compared absorbable subcuticular suture versus surgical staples for skin closure of CD. Surgical staples had shorter operating time but absorbable subcuticular suture had decreased post-operative pain and better cosmesis at the 6 week post-operative visit (Frishman, 1997). Rousseau, J. presented opposing findings in her RCT "A Randomized Study Comparing Subcuticular Sutures Versus Staples for Skin Closure at Cesarean Sections". In this study, staples had better cosmesis, decreased pain at the post-operative visit, and shorter operating time (Rousseau, 2009). Neither study assessed wound disruption or infection directly. With such widely varying findings and lack of data there is a need to identify the cesarean section skin closure which provides the best outcomes for the most common major surgical procedure in women.
We have undertaken a RCT to compare surgical staples vs. absorbable subcuticular suture for the closure of the skin in cesarean sections. Our primary outcome is a composite wound morbidity outcome (including wound disruption or infection). Assuming a baseline wound morbidity of 8%, Power of 80%, and a decrease of wound morbidity to 4%, a sample size of 1,204 will be required. Our secondary outcomes will include cosmesis, post-operative pain, health service use/cost, procedure time, and patient satisfaction.
The study was terminated after recruitment of approximately 400 subjects after administrative review (see publication: Figueroa et al. Obstet Gynecol. 2013 Jan;121(1):33-8.)
- Conditions
- Wound
- Being tested
- Surgical staples, Absorbable Surgical Suture
- Keywords
- Staples, Sutures, Cesarean Delivery, Wound, Skin Closure, Wound infection, Wound disruption
- Medical subject headings
- Wounds and Injuries, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical staplesDevice
Also called Proximate Plus MD 35 W, Ethicon Endo-surgery
Surgical staples will be used once for wound closure.
Absorbable Surgical SutureDevice
Also called 4-0 Monocryl, Ethicon
Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.
| Study group | Role | What they receive |
|---|---|---|
| Absorbable Subcuticular Surgical Suture | Active comparator | Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. Receives: Device: Absorbable Surgical Suture |
| Surgical staples | Active comparator | Patients in this arm will receive surgical staples for wound closure. Receives: Device: Surgical staples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Subjects With Composite Wound Morbidity.
this outcome measure included a composite of either disruption and/ or infection of the wound at 4 - 6 weeks post partum. The number of subjects experiencing wound disruption and or wound infection at 4 - 6 weeks post delivery was assessed
Measured: 4-6 weeks post partum
Secondary outcomes (7)
Composite Cosmesis Score (Stony Brook Scar Evaluation Score - SBSES) Core - SBSES))
The SBSES assessed five scar components: width, height, color, suture marks and overall appearance. Each component was assigned a score of 0 or 1 with a total sum range of 0 (worst) to 5 (best).
Measured: at the end of follow up, 4 - 6 weeks post partum
Operative Procedure Time.
time for procedure as measured in minutes
Measured: Intraoperative, at time of intervention.
Post Operative Pain - 4 - 6 Weeks Post Delivery
the visual analog pain scale was used. The range is 0 to 10 for reporting pain: 0 = no pain and 10 = unbearable distress
Measured: at end of follow-up, 4 - 6 weeks post partum
Post Operative Pain - 72 - 96 Hours Post Delivery
the visual analog pain scale was used. The range is 0 to 10 for reporting pain: 0 = no pain and 10 = unbearable distress
Measured: 72 - 96 hours post delivery
Subject Reported Satisfaction With Appearance of Scar
Subject reported satisfaction of the scar appearance was assessed by using a scale of 1 - 5 with 1 being worst appearance and 5 being best appearance
Measured: 4 - 6 weeks post delivery
Subject Satisfaction With Comfort With Scar
Scar discomfort satisfaction was reported by subject perception using a scale of 1 - 5. A score of 1 would be the worst comfort and a score of 5 would be the best comfort
Measured: at end of follow-up, 4 - 6 weeks post partum
Subject Satisfaction With Location of Scar
Satisfaction with location of scar was reported by subject using a scale of 1 - 5. A score of 1 would be the worst location of a scar and a score of 5 would be the best location of a scar
Measured: at end of follow-up, 4 - 6 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 posted5 Nov 2009 (estimated)
- Study startAug 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: New studies were reporting that sutures are beneficial, hindering the possibility of enrollment.
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 (4)Papers the sponsor has linked to this study.
- Other trials for WoundStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Tita, University of Alabama at Birmingham
- Investigators
- Dana Figueroa, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008449
- Sponsor's protocol ID
- X090531008
- Acronym
- SVS
- Status last verified
- Sep 2014
- First submitted
- 4 Nov 2009
- Last updated
- 3 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rousseau 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 19254586Frishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30.
PubMed 9350017Alderdice F, McKenna D, Dornan J. Techniques and materials for skin closure in caesarean section. Cochrane Database Syst Rev. 2003;(2):CD003577. doi: 10.1002/14651858.CD003577.
PubMed 12804476Figueroa D, Jauk VC, Szychowski JM, Garner R, Biggio JR, Andrews WW, Hauth J, Tita AT. Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Jan;121(1):33-8. doi: 10.1097/aog.0b013e31827a072c.
PubMed 23262925
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Staples vs. Absorbable Subcuticular Suture for Wound Closure of Cesarean Deliveries
- ClinicalTrials.gov ID
- NCT01008449
- Acronym / sponsor ID
- SVS / X090531008
- Conditions
- Wound
- Keywords
- Staples, Sutures, Cesarean Delivery, Wound, Skin Closure, Wound infection, Wound disruption
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: New studies were reporting that sutures are beneficial, hindering the possibility of enrollment.
- Enrolment
- 398 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 5 Nov 2009 (estimated)
- Results
- Posted 3 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this randomized controlled trial is to compare wound morbidity (including disruption and infection) in surgical staples versus absorbable subcuticular suture for wound closure in cesarean deliveries.
Detailed description
Cesarean delivery (CD) is a common surgical procedure with over 1 million performed annually in the United States. The rate of CD is steadily increasing. In 2006, an estimated 31.1% of U.S. births were by CD. Approximately two thirds of these are primary procedures and 90% of CD will later undergo a repeat cesarean delivery. The rise in CD has been attributed to changes in physician and patient expectations, attitudes about risk, and changes in clinical practice. These include decreased vaginal birth after cesarean delivery (VBAC), breech vaginal deliveries, and operative vaginal deliveries as well as an increase in maternal request, failed induction of labor, and elective repeat CD. The CD rate is expected to rise as high as 40-50% in the next decade if the increasing trend continues unabated.
Despite the large number of CD performed, there is no agreed standard for skin closure. The most commonly used materials are surgical staples and absorbable subcuticular suture. Staples have a clear benefit in decreasing operating time. In theory, staples also have a decreased chance of bacterial migration into the wound, decreased tension at the incision edges, and less damage to capillaries in the subcuticular layer of skin than absorbable subcuticular suture. However, some argue that staples are more painful and have a worse cosmetic appearance. This is especially the case for staples that remain in place longer than recommended and leave "track marks." Staples are also less visually appealing to patients.
The Cochrane Collaboration identified one randomized controlled trial (RCT) that addressed skin closure for CD (Alderice, 2003). This study included 66 women and compared absorbable subcuticular suture versus surgical staples for skin closure of CD. Surgical staples had shorter operating time but absorbable subcuticular suture had decreased post-operative pain and better cosmesis at the 6 week post-operative visit (Frishman, 1997). Rousseau, J. presented opposing findings in her RCT "A Randomized Study Comparing Subcuticular Sutures Versus Staples for Skin Closure at Cesarean Sections". In this study, staples had better cosmesis, decreased pain at the post-operative visit, and shorter operating time (Rousseau, 2009). Neither study assessed wound disruption or infection directly. With such widely varying findings and lack of data there is a need to identify the cesarean section skin closure which provides the best outcomes for the most common major surgical procedure in women.
We have undertaken a RCT to compare surgical staples vs. absorbable subcuticular suture for the closure of the skin in cesarean sections. Our primary outcome is a composite wound morbidity outcome (including wound disruption or infection). Assuming a baseline wound morbidity of 8%, Power of 80%, and a decrease of wound morbidity to 4%, a sample size of 1,204 will be required. Our secondary outcomes will include cosmesis, post-operative pain, health service use/cost, procedure time, and patient satisfaction.
The study was terminated after recruitment of approximately 400 subjects after administrative review (see publication: Figueroa et al. Obstet Gynecol. 2013 Jan;121(1):33-8.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absorbable Subcuticular Surgical Suture | Active comparator | Device: Absorbable Surgical SuturePatients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. |
| Surgical staples | Active comparator | Device: Surgical staplesPatients in this arm will receive surgical staples for wound closure. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- cesarean delivery
Key exclusion criteria (4 listed)
- chronic use of immunosuppressive agents ( e.g.po steroids > 2 weeks)
- significant immune compromising disease (e.g. AIDS, CD4<200)
- contraindication to standard post operative pain management (acetaminophen, ibuprofen, oxycodone)
- refusal or inability to give consent
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 |
|---|---|---|
| Surgical staplesAlso: Proximate Plus MD 35 W, Ethicon Endo-surgerySurgical staples will be used once for wound closure. | Device | Surgical staples |
| Absorbable Surgical SutureAlso: 4-0 Monocryl, EthiconAbsorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery. | Device | Absorbable Subcuticular Surgical Suture |
Primary outcome
Percent of Subjects With Composite Wound Morbidity.
Time frame: 4-6 weeks post partum
this outcome measure included a composite of either disruption and/ or infection of the wound at 4 - 6 weeks post partum. The number of subjects experiencing wound disruption and or wound infection at 4 - 6 weeks post delivery was assessed
7 secondary outcomes
Composite Cosmesis Score (Stony Brook Scar Evaluation Score - SBSES) Core - SBSES))
Time frame: at the end of follow up, 4 - 6 weeks post partum
Operative Procedure Time.
Time frame: Intraoperative, at time of intervention.
Post Operative Pain - 4 - 6 Weeks Post Delivery
Time frame: at end of follow-up, 4 - 6 weeks post partum
Post Operative Pain - 72 - 96 Hours Post Delivery
Time frame: 72 - 96 hours post delivery
Subject Reported Satisfaction With Appearance of Scar
Time frame: 4 - 6 weeks post delivery
Subject Satisfaction With Comfort With Scar
Time frame: at end of follow-up, 4 - 6 weeks post partum
Subject Satisfaction With Location of Scar
Time frame: at end of follow-up, 4 - 6 weeks post partum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 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 12804476Alderdice F, McKenna D, Dornan J. Techniques and materials for skin closure in caesarean section. Cochrane Database Syst Rev. 2003;(2):CD003577. doi: 10.1002/14651858.CD003577.
- Derived from this study: PubMed 23262925Figueroa D, Jauk VC, Szychowski JM, Garner R, Biggio JR, Andrews WW, Hauth J, Tita AT. Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Jan;121(1):33-8. doi: 10.1097/aog.0b013e31827a072c.
- Link to study results on PubMedLink provided by the sponsor.
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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.
Dana Figueroa, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical staples and Absorbable Surgical Suture in people with Wound, run by University of Alabama at Birmingham 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 1 inclusion and 4 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 3 Sep 2014. 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 3 Sep 2014). 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?
Percent of Subjects With Composite Wound Morbidity. (time frame: 4-6 weeks post partum). 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 NCT01008449, which also lists 4 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 3 Sep 2014.