Wound ComplicationsPhase 2/3NCT01114451
Early Versus Delayed Skin Staple Removal Following Cesarean Delivery in the Obese Patient
A Phase 2/3 study testing Removal of surgical skin staples in people with Wound Complications and Obesity, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
Whenever a person has a cesarean section there is a risk that there will be a problem with healing of the wound. The most common type of wound healing problem is separation and opening of the skin and fatty tissue just beneath the skin. Read more about this study
- Who is it for?
- Ages 18 to 52 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wound Complications, Obesity
- What is being tested?
- Removal of surgical skin staples
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Feb 2012
- Phase
- Phase 2/3
- 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 52 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cesarean delivery
- Body Mass Index ≥ 30 kg/m2
- Transverse (Pfannenstiel or Joel-Cohen) skin incision
- Subcutaneous wound depth ≥ 2 cm
- Surgical staple skin closure
Who cannot join
- Vertical skin incision
- Non-staple skin closure
- Wound complication (superficial dehiscence, abscess, seroma, hematoma, cellulitis)
- Any complication necessitating prolonged hospitalization
Trial locations and contacts
1 site in 1 country.
United States1 site
Greenville Memorial Hospital
Greenville, South Carolina, 29605
About this study
Official title: A Randomized Controlled Trial of Early Versus Delayed Skin Staple Removal Following Cesarean Delivery in the Obese Patient
Whenever a person has a cesarean section there is a risk that there will be a problem with healing of the wound. The most common type of wound healing problem is separation and opening of the skin and fatty tissue just beneath the skin. This type of wound healing problem happens more often when the patient has a high body weight. In most cases, metal staples are used to bring the skin together to close the wound. Usually, the staples are left in place for a longer time when the woman is heavy, in hopes of decreasing the chance of wound healing problems. But it is not known if leaving the staples in for a longer time is actually helpful. In some cases, leaving the staples in longer may cause more pain and will require you to see the doctor again to get the staples taken out. The purpose of this study is to see if there is any difference in how the wound heals in heavy women after cesarean section when the skin staples are removed after a short period of time versus a long period of time.
Read the detailed description
Cesarean delivery in the obese gravida is associated with numerous perioperative risks, the most frequent of which is postoperative wound disruption, with a mean incidence of 15%. With the exception of closure of the subcutaneous adipose layer, other useful measures to decrease wound complications in the obese gravida have either not been studied or lack sufficient evidence upon which to base a recommendation.
One such intervention is the delayed removal of surgical skin staples. Skin staplers, which were first introduced in the 1980's, were "grandfathered" through the United States Food and Drug Administration (FDA) approval process, and have since become a widely utilized technique for skin closure. Although neither the FDA nor device manufacturers make a specific recommendation, skin staples are commonly left in situ anywhere from 3 - 10 days.
The physiologic rationale for delayed staple removal is unclear. Wound healing involves four main stages including hemostasis, inflammation, granulation, and remodeling. Each phase can be further broken down into overlapping steps. Reapproximation of the skin edges with staples enables epithelialization, resulting in wound closure by a thin layer of cells by 48 hours post-operatively. Although overall wound healing appears to be delayed in the setting of obesity, whether the specific process of epithelialization is affected is unknown. Therefore, there may not be a physiologic basis for delaying staple removal in obese women.
Furthermore, delayed staple removal has potentially negative effects on patient care that may not be balanced by clinical benefits. Delayed staple removal may be associated with prolongation of patient discomfort, additional clinical visits and increased associated costs. These issues caused us to question whether the practice of delayed skin staple removal in obese women is warranted.
Therefore, this clinical trial is designed to compare wound healing outcomes after cesarean following early (postoperative day #3) versus delayed (postoperative day #7 - 10) skin staple removal in the obese patient.
- Conditions
- Wound Complications, Obesity
- Being tested
- Removal of surgical skin staples
- Keywords
- Cesarean delivery, Obesity, Skin staples, Wound complications
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removal of surgical skin staplesProcedure or surgery
Skin staples will be removed using standard technique with subsequent placement of steri-trips
| Study group | Role | What they receive |
|---|---|---|
| Early Staple Removal | Experimental | Skin staple removal on post-operative day #3 Receives: Procedure: Removal of surgical skin staples |
| Delayed Staple Removal | Experimental | Skin staple removal on post-operative day 7-10 Receives: Procedure: Removal of surgical skin staples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a superficial wound disruption as a measure of efficacy.
Any separation of the wound edge measuring greater than 1 cm that occurs from the time of staple placement to final wound assessment which occurs at 7-10 days after surgery.
Measured: 7-10 days after surgery
Secondary outcomes (4)
Number of participants who develop a wound seroma.
A collection of fluid within the subcutaneous fatty tissue layer.
Measured: 6 weeks after surgery
Number of participants who develop a hematoma of the wound.
A collection of clotted blood within the subcutaneous tissues.
Measured: 6 weeks after surgery
Number of participants who develop a surgical site infection
Infection involving only skin or subcutaneous tissue of the incision which occurs within 30 days after the operation.
Measured: 6 weeks after surgery
Frequency of Visual Analogue Pain Score
Patient rating of pain on a 1-10 scale as assessed at the 7-10 day postoperative visit.
Measured: 7-10 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startOct 2009
- Primary completionNov 2011
- Study completionFeb 2012
Why it stopped: Funding limits exceeded prior to complete enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Wound ComplicationsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis S Nuthalapaty, MD, Principal investigator, Prisma Health-Upstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114451
- Sponsor's protocol ID
- Pro00002576
- Status last verified
- Mar 2021
- First submitted
- 16 Apr 2010
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Nuthalapaty FS, Rouse DJ. The impact of obesity on obstetrical practice and outcome. Clin Obstet Gynecol. 2004 Dec;47(4):898-913; discussion 980-1. doi: 10.1097/01.grf.0000135358.34673.48. No abstract available.
PubMed 15596944Sarsam SE, Elliott JP, Lam GK. Management of wound complications from cesarean delivery. Obstet Gynecol Surv. 2005 Jul;60(7):462-73. doi: 10.1097/01.ogx.0000166603.43959.aa.
PubMed 15995563Berghella 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 16260200American College of Obstetricians and Gynecologists. ACOG Committee Opinion number 315, September 2005. Obesity in pregnancy. Obstet Gynecol. 2005 Sep;106(3):671-5. doi: 10.1097/00006250-200509000-00054.
PubMed 16135613Walsh C, Scaife C, Hopf H. Prevention and management of surgical site infections in morbidly obese women. Obstet Gynecol. 2009 Feb;113(2 Pt 1):411-5. doi: 10.1097/AOG.0b013e3181945625. No abstract available.
PubMed 19155915
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Early Versus Delayed Skin Staple Removal Following Cesarean Delivery in the Obese Patient
- ClinicalTrials.gov ID
- NCT01114451
- Acronym / sponsor ID
- Pro00002576
- Conditions
- Wound Complications, Obesity
- Keywords
- Cesarean delivery, Obesity, Skin staples, Wound complications
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding limits exceeded prior to complete enrollment.
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 3 May 2010 (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.
Whenever a person has a cesarean section there is a risk that there will be a problem with healing of the wound. The most common type of wound healing problem is separation and opening of the skin and fatty tissue just beneath the skin. This type of wound healing problem happens more often when the patient has a high body weight. In most cases, metal staples are used to bring the skin together to close the wound. Usually, the staples are left in place for a longer time when the woman is heavy, in hopes of decreasing the chance of wound healing problems. But it is not known if leaving the staples in for a longer time is actually helpful. In some cases, leaving the staples in longer may cause more pain and will require you to see the doctor again to get the staples taken out. The purpose of this study is to see if there is any difference in how the wound heals in heavy women after cesarean section when the skin staples are removed after a short period of time versus a long period of time.
Detailed description
Cesarean delivery in the obese gravida is associated with numerous perioperative risks, the most frequent of which is postoperative wound disruption, with a mean incidence of 15%. With the exception of closure of the subcutaneous adipose layer, other useful measures to decrease wound complications in the obese gravida have either not been studied or lack sufficient evidence upon which to base a recommendation.
One such intervention is the delayed removal of surgical skin staples. Skin staplers, which were first introduced in the 1980's, were "grandfathered" through the United States Food and Drug Administration (FDA) approval process, and have since become a widely utilized technique for skin closure. Although neither the FDA nor device manufacturers make a specific recommendation, skin staples are commonly left in situ anywhere from 3 - 10 days.
The physiologic rationale for delayed staple removal is unclear. Wound healing involves four main stages including hemostasis, inflammation, granulation, and remodeling. Each phase can be further broken down into overlapping steps. Reapproximation of the skin edges with staples enables epithelialization, resulting in wound closure by a thin layer of cells by 48 hours post-operatively. Although overall wound healing appears to be delayed in the setting of obesity, whether the specific process of epithelialization is affected is unknown. Therefore, there may not be a physiologic basis for delaying staple removal in obese women.
Furthermore, delayed staple removal has potentially negative effects on patient care that may not be balanced by clinical benefits. Delayed staple removal may be associated with prolongation of patient discomfort, additional clinical visits and increased associated costs. These issues caused us to question whether the practice of delayed skin staple removal in obese women is warranted.
Therefore, this clinical trial is designed to compare wound healing outcomes after cesarean following early (postoperative day #3) versus delayed (postoperative day #7 - 10) skin staple removal in the obese patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Staple Removal | Experimental | Procedure: Removal of surgical skin staplesSkin staple removal on post-operative day #3 |
| Delayed Staple Removal | Experimental | Procedure: Removal of surgical skin staplesSkin staple removal on post-operative day 7-10 |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Cesarean delivery
- Body Mass Index ≥ 30 kg/m2
- Transverse (Pfannenstiel or Joel-Cohen) skin incision
- Subcutaneous wound depth ≥ 2 cm
- Surgical staple skin closure
Key exclusion criteria (4 listed)
- Vertical skin incision
- Non-staple skin closure
- Wound complication (superficial dehiscence, abscess, seroma, hematoma, cellulitis)
- Any complication necessitating prolonged hospitalization
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 |
|---|---|---|
| Removal of surgical skin staplesSkin staples will be removed using standard technique with subsequent placement of steri-trips | Procedure or surgery | Delayed Staple Removal, Early Staple Removal |
Primary outcome
Number of participants with a superficial wound disruption as a measure of efficacy.
Time frame: 7-10 days after surgery
Any separation of the wound edge measuring greater than 1 cm that occurs from the time of staple placement to final wound assessment which occurs at 7-10 days after surgery.
4 secondary outcomes
Number of participants who develop a wound seroma.
Time frame: 6 weeks after surgery
Number of participants who develop a hematoma of the wound.
Time frame: 6 weeks after surgery
Number of participants who develop a surgical site infection
Time frame: 6 weeks after surgery
Frequency of Visual Analogue Pain Score
Time frame: 7-10 days after surgery
Results and safety
The study was stopped early (reason given: Funding limits exceeded prior to complete enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Background: PubMed 15596944Nuthalapaty FS, Rouse DJ. The impact of obesity on obstetrical practice and outcome. Clin Obstet Gynecol. 2004 Dec;47(4):898-913; discussion 980-1. doi: 10.1097/01.grf.0000135358.34673.48. No abstract available.
- Background: PubMed 15995563Sarsam SE, Elliott JP, Lam GK. Management of wound complications from cesarean delivery. Obstet Gynecol Surv. 2005 Jul;60(7):462-73. doi: 10.1097/01.ogx.0000166603.43959.aa.
- Background: 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.
- Background: PubMed 16135613American College of Obstetricians and Gynecologists. ACOG Committee Opinion number 315, September 2005. Obesity in pregnancy. Obstet Gynecol. 2005 Sep;106(3):671-5. doi: 10.1097/00006250-200509000-00054.
- Background: PubMed 19155915Walsh C, Scaife C, Hopf H. Prevention and management of surgical site infections in morbidly obese women. Obstet Gynecol. 2009 Feb;113(2 Pt 1):411-5. doi: 10.1097/AOG.0b013e3181945625. No abstract available.
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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.
Francis S Nuthalapaty, MD principal investigator
Prisma Health-Upstate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Removal of surgical skin staples in people with Wound Complications and Obesity, run by Prisma Health-Upstate 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 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 17 Mar 2021. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Funding limits exceeded prior to complete enrollment.). 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?
Number of participants with a superficial wound disruption as a measure of efficacy. (time frame: 7-10 days after surgery). 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 NCT01114451, which also lists 5 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 17 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.