Cesarean Wound Disruption With Postnatal ComplicationNCT06543329
Comparative Analysis of Subcuticular Suture Materials in Cesarean Section
A study testing polyglactin 910, poliglecaprone 25 and polypropylene in people with Cesarean Wound Disruption With Postnatal Complication, run by Cairo University at 1 site in Egypt.
Trial summary
1.1. Background and Rationale Cesarean section is one of the most common surgical procedures performed worldwide. The choice of suture material for closing the skin incision is crucial, as it can influence wound healing, the risk of wound complications, and the cosmetic outcome. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Wound Disruption With Postnatal Complication
- What is being tested?
- polyglactin 910, poliglecaprone 25 and polypropylene
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 30 Aug 2025
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 20-45 years old.
- BMI = or more than 40 kg/m2
- Primigravida or not more than the previous 1 cesarean section.
- Will undergo a lower-segment cesarean section.
- Hb: ≥ 10 gm/dl.
- Viable fetus.
- No history of medical comorbidities.
Who cannot join
- History of urogenital tract infection within 2 weeks before cesarean delivery.
- Presence of clinical signs of infection at the time of delivery including PPROM and intraamniotic infection.
- Medical comorbidities (hypertension, diabetes, etc.).
- Hypersensitivity to any of the suture materials.
- Women with abnormal placentation (placental abruption or placenta previa).
- History of systemic corticosteroid intake during their pregnancy for 2 weeks or more.
Show all 9Show fewer
- History of previous surgical site infection.
- Immune-compromised women.
- Women refused to participate in the study or could not obtain consent.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of medicine, Kasr el ainy hospital, Cairo university
Cairo, 11562
About this study
Official title: Comparative Analysis Between Different Suture Materials in Subcuticular Cesarean Wound Closure in Woman With BMI 40 or Greater in Cesarean Delivery: An Interventional Randomized Comparative Clinical Trial
1.1. Background and Rationale Cesarean section is one of the most common surgical procedures performed worldwide. The choice of suture material for closing the skin incision is crucial, as it can influence wound healing, the risk of wound complications, and the cosmetic outcome. Subcuticular suturing, a technique where the suture is placed just under the skin, is favored for its aesthetic benefits and reduced risk of infection. However, the type of suture material used can significantly impact these outcomes. This study aims to provide a comparative analysis of various subcuticular suture materials used in cesarean sections, focusing on wound complications and incision outcomes.
1.2. Objective of the Study The objective of this study is to compare the incidence of wound complications and the quality of incision outcomes associated with different subcuticular suture materials used in cesarean sections. By doing so, the investigators aim to identify the most effective suture material for minimizing wound complications and optimizing cosmetic results.
Read the detailed description
2.1. Surgical Techniques in Cesarean Section Cesarean section involves multiple surgical steps, including skin incision, uterine incision, and closure of the incisions. The subcuticular suturing technique is often preferred for skin closure due to its potential for better cosmetic results and lower infection rates compared to other methods like staples or interrupted sutures.
2.2. Types of Suture Materials
Suture materials can be broadly categorized into absorbable and non-absorbable, and further into monofilament and multifilament types. Common suture materials used in subcuticular skin closure include:
Absorbable Sutures: Poliglecaprone (Monocryl), Polyglactin (Vicryl), Polydioxanone (PDS).
Non-Absorbable Sutures: Nylon, Polypropylene (Prolene), Silk. 2.3. Previous Studies on Suture Materials in Cesarean Section Previous studies have explored the impact of different suture materials on wound healing, infection rates, and cosmetic outcomes. Research indicates varying results, with some studies favoring absorbable sutures for their reduced need for removal and lower infection rates, while others suggest non-absorbable sutures may provide stronger wound support. However, comprehensive comparative analyses specific to cesarean sections remain limited.
- Methodology 3.1. Study Design This study will use a prospective, randomized controlled trial design. Participants undergoing elective cesarean sections will be randomly assigned to receive subcuticular suturing with one of several suture materials.
- Being tested
- polyglactin 910, poliglecaprone 25, polypropylene, polyester
- Keywords
- cesarean section, wound complication, obesity, monocryl, vicryl, prolene, polyester
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyglactin 910Procedure or surgery
Also called VICRYL
75 PARTICIPANT, Vicryl suture was used in subcuticular suture
poliglecaprone 25Procedure or surgery
Also called monocryl
75 PARTICIPANT, monocryl suture was used in subcuticular suture
polypropyleneProcedure or surgery
Also called prolene
75 PARTICIPANT, Prolene suture was used in subcuticular suture
polyesterProcedure or surgery
Also called ETHIBOND EXCEL Suture
75 PARTICIPANT, Polyester suture was used in subcuticular suture
| Study group | Role | What they receive |
|---|---|---|
| polyglactin 910 | Active comparator | - Group A: (75) women with subcuticular suture polyglactin 910, braided, (VICRYL RAPIDE®; Ethicon) was used in subcuticular skin closure. Receives: Procedure: polyglactin 910 |
| poliglecaprone 25 | Active comparator | Group A: (75) women with subcuticular suture poliglecaprone 25, (MONOCRYL) was used in subcuticular skin closure. Receives: Procedure: poliglecaprone 25 |
| polypropylene | Active comparator | Group A: (75) women with subcuticular suture polypropylene, (PROLENE) was used in subcuticular skin closure. Receives: Procedure: polypropylene |
| POLYESTER | Active comparator | Group A: (75) women with subcuticular suture POLYESTER, (ETHIBOND EXCEL Suture) was used in subcuticular skin closure. Receives: Procedure: polyester |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of any documented wound complication during the first six weeks postpartum
This measure tracks the incidence of wound complications within six weeks postpartum, including infection, dehiscence, seroma, hematoma, ecchymosis, pus, delayed healing, and secondary suture needs.
Measurement Tools:
Clinical examinations during follow-up visits Patient self-reports Review of medical records
Assessment Procedure:
Patients will undergo follow-up visits at 2, 4, and 6 weeks postpartum. Complications will be documented through clinical exams, patient reports, and medical record reviews.
Calculation:
The rate is calculated as the number of patients with any wound complication divided by the total number of patients, expressed as a percentage.
Measured: 6 weeks
Secondary outcomes (1)
cosmetics satisfaction
This measure assesses the cosmetic appearance of surgical wounds post-abdominal myomectomy.
Measurement Tool:
A standardized cosmetic appearance scale will be used, such as the Patient and Observer Scar Assessment Scale (POSAS).
Assessment Procedure:
Evaluations will be conducted at follow-up visits (2, 4, and 6 weeks postpartum) by both the patient and a clinician.
Parameters Assessed:
Scar color, texture, and overall appearance Patient satisfaction with the cosmetic outcome
Calculation:
Scores from the POSAS will be averaged to determine the overall cosmetic appearance rating.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cesarean Wound Disruption With Postnatal ComplicationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Parallel groups
- Model description
- This prospective interventional randomized comparative clinical trial was carried out on 300 pregnant women scheduled for elective caesarean section at operative theater
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Kafrelsheikh University
- Responsible party
- Principal investigator, ahmed nagy shaker ramadan, Cairo University
- Investigators
- Ahmed N Afifi, MD, Principal investigator, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543329
- Sponsor's protocol ID
- AA-2024-3
- Status last verified
- Aug 2024
- First submitted
- 27 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rodel RL, Gray KM, Quiner TE, Bodea Braescu A, Gerkin R, Perlow JH. Cesarean wound closure in body mass index 40 or greater comparing suture to staples: a randomized clinical trial. Am J Obstet Gynecol MFM. 2021 Jan;3(1):100271. doi: 10.1016/j.ajogmf.2020.100271. Epub 2020 Oct 27.
PubMed 33451603Basha SL, Rochon ML, Quinones JN, Coassolo KM, Rust OA, Smulian JC. Randomized controlled trial of wound complication rates of subcuticular suture vs staples for skin closure at cesarean delivery. Am J Obstet Gynecol. 2010 Sep;203(3):285.e1-8. doi: 10.1016/j.ajog.2010.07.011.
PubMed 20816153Frishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30.
PubMed 9350017Clay FS, Walsh CA, Walsh SR. Staples vs subcuticular sutures for skin closure at cesarean delivery: a metaanalysis of randomized controlled trials. Am J Obstet Gynecol. 2011 May;204(5):378-83. doi: 10.1016/j.ajog.2010.11.018. Epub 2010 Dec 31.
PubMed 21195384Tuuli MG, Rampersad RM, Carbone JF, Stamilio D, Macones GA, Odibo AO. Staples compared with subcuticular suture for skin closure after cesarean delivery: a systematic review and meta-analysis. Obstet Gynecol. 2011 Mar;117(3):682-690. doi: 10.1097/AOG.0b013e31820ad61e.
PubMed 21343772Nayak G B, Saha PK, Bagga R, Joshi B, Rohilla M, Gainder S, Sikka P. Wound complication among different skin closure techniques in the emergency cesarean section: a randomized control trial. Obstet Gynecol Sci. 2020 Jan;63(1):27-34. doi: 10.5468/ogs.2020.63.1.27. Epub 2019 Dec 23.
PubMed 31970125Aabakke AJM, Krebs L, Pipper CB, Secher NJ. Subcuticular suture compared with staples for skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Oct;122(4):878-884. doi: 10.1097/AOG.0b013e3182a5f0c3.
PubMed 24084548Buresch AM, Van Arsdale A, Ferzli M, Sahasrabudhe N, Sun M, Bernstein J, Bernstein PS, Ngai IM, Garry DJ. Comparison of Subcuticular Suture Type for Skin Closure After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2017 Sep;130(3):521-526. doi: 10.1097/AOG.0000000000002200.
PubMed 28796687Figueroa 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 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis Between Different Suture Materials in Subcuticular Cesarean Wound Closure in Woman With BMI 40 or Greater in Cesarean Delivery: An Interventional Randomized Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT06543329
- Acronym / sponsor ID
- AA-2024-3
- Keywords
- cesarean section, wound complication, obesity, monocryl, vicryl, prolene, polyester
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Kafrelsheikh University
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 9 Aug 2024 (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.
1.1. Background and Rationale Cesarean section is one of the most common surgical procedures performed worldwide. The choice of suture material for closing the skin incision is crucial, as it can influence wound healing, the risk of wound complications, and the cosmetic outcome. Subcuticular suturing, a technique where the suture is placed just under the skin, is favored for its aesthetic benefits and reduced risk of infection. However, the type of suture material used can significantly impact these outcomes. This study aims to provide a comparative analysis of various subcuticular suture materials used in cesarean sections, focusing on wound complications and incision outcomes.
1.2. Objective of the Study The objective of this study is to compare the incidence of wound complications and the quality of incision outcomes associated with different subcuticular suture materials used in cesarean sections. By doing so, the investigators aim to identify the most effective suture material for minimizing wound complications and optimizing cosmetic results.
Detailed description
2.1. Surgical Techniques in Cesarean Section Cesarean section involves multiple surgical steps, including skin incision, uterine incision, and closure of the incisions. The subcuticular suturing technique is often preferred for skin closure due to its potential for better cosmetic results and lower infection rates compared to other methods like staples or interrupted sutures.
2.2. Types of Suture Materials
Suture materials can be broadly categorized into absorbable and non-absorbable, and further into monofilament and multifilament types. Common suture materials used in subcuticular skin closure include:
Absorbable Sutures: Poliglecaprone (Monocryl), Polyglactin (Vicryl), Polydioxanone (PDS).
Non-Absorbable Sutures: Nylon, Polypropylene (Prolene), Silk. 2.3. Previous Studies on Suture Materials in Cesarean Section Previous studies have explored the impact of different suture materials on wound healing, infection rates, and cosmetic outcomes. Research indicates varying results, with some studies favoring absorbable sutures for their reduced need for removal and lower infection rates, while others suggest non-absorbable sutures may provide stronger wound support. However, comprehensive comparative analyses specific to cesarean sections remain limited.
- Methodology 3.1. Study Design This study will use a prospective, randomized controlled trial design. Participants undergoing elective cesarean sections will be randomly assigned to receive subcuticular suturing with one of several suture materials.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- This prospective interventional randomized comparative clinical trial was carried out on 300 pregnant women scheduled for elective caesarean section at operative theater
| Arm | Type | Receives |
|---|---|---|
| polyglactin 910 | Active comparator | Procedure: polyglactin 910- Group A: (75) women with subcuticular suture polyglactin 910, braided, (VICRYL RAPIDE®; Ethicon) was used in subcuticular skin closure. |
| poliglecaprone 25 | Active comparator | Procedure: poliglecaprone 25Group A: (75) women with subcuticular suture poliglecaprone 25, (MONOCRYL) was used in subcuticular skin closure. |
| polypropylene | Active comparator | Procedure: polypropyleneGroup A: (75) women with subcuticular suture polypropylene, (PROLENE) was used in subcuticular skin closure. |
| POLYESTER | Active comparator | Procedure: polyesterGroup A: (75) women with subcuticular suture POLYESTER, (ETHIBOND EXCEL Suture) was used in subcuticular skin closure. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women aged 20-45 years old.
- BMI = or more than 40 kg/m2
- Primigravida or not more than the previous 1 cesarean section.
- Will undergo a lower-segment cesarean section.
- Hb: ≥ 10 gm/dl.
Key exclusion criteria (9 listed)
- History of urogenital tract infection within 2 weeks before cesarean delivery.
- Presence of clinical signs of infection at the time of delivery including PPROM and intraamniotic infection.
- Medical comorbidities (hypertension, diabetes, etc.).
- Hypersensitivity to any of the suture materials.
- Women with abnormal placentation (placental abruption or placenta previa).
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 |
|---|---|---|
| polyglactin 910Also: VICRYL75 PARTICIPANT, Vicryl suture was used in subcuticular suture | Procedure or surgery | polyglactin 910 |
| poliglecaprone 25Also: monocryl75 PARTICIPANT, monocryl suture was used in subcuticular suture | Procedure or surgery | poliglecaprone 25 |
| polypropyleneAlso: prolene75 PARTICIPANT, Prolene suture was used in subcuticular suture | Procedure or surgery | polypropylene |
| polyesterAlso: ETHIBOND EXCEL Suture75 PARTICIPANT, Polyester suture was used in subcuticular suture | Procedure or surgery | POLYESTER |
Primary outcome
the rate of any documented wound complication during the first six weeks postpartum
Time frame: 6 weeks
This measure tracks the incidence of wound complications within six weeks postpartum, including infection, dehiscence, seroma, hematoma, ecchymosis, pus, delayed healing, and secondary suture needs. Measurement Tools: Clinical examinations during follow-up visits Patient self-reports Review of medical records Assessment Procedure: Patients will undergo follow-up visits at 2, 4, and 6 weeks postpartum. Complications will be documented through clinical exams, patient reports, and medical record reviews. Calculation: The rate is calculated as the number of patients with any wound complication divided by the total number of patients, expressed as a percentage.
1 secondary outcome
cosmetics satisfaction
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Background: PubMed 33451603Rodel RL, Gray KM, Quiner TE, Bodea Braescu A, Gerkin R, Perlow JH. Cesarean wound closure in body mass index 40 or greater comparing suture to staples: a randomized clinical trial. Am J Obstet Gynecol MFM. 2021 Jan;3(1):100271. doi: 10.1016/j.ajogmf.2020.100271. Epub 2020 Oct 27.
- Background: PubMed 20816153Basha SL, Rochon ML, Quinones JN, Coassolo KM, Rust OA, Smulian JC. Randomized controlled trial of wound complication rates of subcuticular suture vs staples for skin closure at cesarean delivery. Am J Obstet Gynecol. 2010 Sep;203(3):285.e1-8. doi: 10.1016/j.ajog.2010.07.011.
- 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 21195384Clay FS, Walsh CA, Walsh SR. Staples vs subcuticular sutures for skin closure at cesarean delivery: a metaanalysis of randomized controlled trials. Am J Obstet Gynecol. 2011 May;204(5):378-83. doi: 10.1016/j.ajog.2010.11.018. Epub 2010 Dec 31.
- Background: PubMed 21343772Tuuli MG, Rampersad RM, Carbone JF, Stamilio D, Macones GA, Odibo AO. Staples compared with subcuticular suture for skin closure after cesarean delivery: a systematic review and meta-analysis. Obstet Gynecol. 2011 Mar;117(3):682-690. doi: 10.1097/AOG.0b013e31820ad61e.
- Background: PubMed 31970125Nayak G B, Saha PK, Bagga R, Joshi B, Rohilla M, Gainder S, Sikka P. Wound complication among different skin closure techniques in the emergency cesarean section: a randomized control trial. Obstet Gynecol Sci. 2020 Jan;63(1):27-34. doi: 10.5468/ogs.2020.63.1.27. Epub 2019 Dec 23.
- Background: PubMed 24084548Aabakke AJM, Krebs L, Pipper CB, Secher NJ. Subcuticular suture compared with staples for skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Oct;122(4):878-884. doi: 10.1097/AOG.0b013e3182a5f0c3.
- Background: PubMed 28796687Buresch AM, Van Arsdale A, Ferzli M, Sahasrabudhe N, Sun M, Bernstein J, Bernstein PS, Ngai IM, Garry DJ. Comparison of Subcuticular Suture Type for Skin Closure After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2017 Sep;130(3):521-526. doi: 10.1097/AOG.0000000000002200.
- Background: 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.
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.
Ahmed N Afifi, MD principal investigator
Kafrelsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polyglactin 910, poliglecaprone 25 and polypropylene in people with Cesarean Wound Disruption With Postnatal Complication, run by Cairo University at 1 site in Egypt.
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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed N Afifi, MD (01098670624, dr_nagy.ahmed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of any documented wound complication during the first six weeks postpartum (time frame: 6 weeks). 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 NCT06543329, which also lists 9 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 9 Aug 2024.