Cesarean SectionAmniotic MembrNCT06770946
The Effect of Amniotic Membrane Application on Post-Cesarean Wound Healing and Cosmetic Outcomes
A study testing Amniotic Membrane Application in people with Cesarean Section, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
This clinical trial evaluates the effectiveness of amniotic membrane application during cesarean delivery in reducing post-surgical complications and improving wound healing and cosmetic outcomes in women aged 18-40 undergoing their first cesarean section. The primary questions this study aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Amniotic Membrane Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2022to 20 May 2023
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female participants aged 18-40 years. Undergoing their first cesarean section. Term pregnancies (≥37 weeks of gestation). Elective cesarean delivery performed under spinal anesthesia. Use of the Pfannenstiel incision method. Willing and able to provide written informed consent.
Who cannot join
- History of previous abdominal surgeries. Presence of chronic conditions such as diabetes mellitus, hypertension, or vascular diseases.
- Pulmonary conditions or collagen tissue disorders affecting wound healing. Signs of infection during delivery. Use of medications or therapies that impair wound healing (e.g., corticosteroids, immunosuppressants).
- Known hypersensitivity to materials or methods used in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Regional Training and Research Hospital
Van, Van, 65090
About this study
Official title: The Effect of Amniotic Membrane Application on Post-Cesarean Wound Healing and Cosmetic Outcomes: a Double-Blind, Randomized Controlled Trial
This clinical trial evaluates the effectiveness of amniotic membrane application during cesarean delivery in reducing post-surgical complications and improving wound healing and cosmetic outcomes in women aged 18-40 undergoing their first cesarean section. The primary questions this study aims to answer are:
- Compared to standard care, Does the amniotic membrane reduce surgical site infections and wound dehiscence?
- Does the amniotic membrane improve patient satisfaction with cosmetic outcomes?
Participants were randomized into two groups: the intervention group received an amniotic membrane application over the cesarean incision site, while the control group underwent cesarean delivery without membrane application. Outcomes were assessed at predefined postoperative intervals, focusing on wound healing, pain levels, and cosmetic satisfaction.
Read the detailed description
This randomized, double-blind, controlled trial investigates the effectiveness of amniotic membrane application in reducing post-cesarean complications, including surgical site infections, wound dehiscence, and scar formation. The trial also assesses its impact on pain management and cosmetic outcomes in women aged 18-40 undergoing their first cesarean section. The study was conducted between May 2022 and May 2023 at Van Regional Training and Research Hospital.
The amniotic membrane, the innermost layer of the placenta, has regenerative, anti-inflammatory, and antimicrobial properties. Its application during cesarean delivery may offer a cost-effective and autologous intervention to enhance surgical outcomes and patient satisfaction.
Objectives:
Primary Objectives:
- Evaluate whether the amniotic membrane reduces surgical complications, including infections, hematoma, and wound dehiscence.
- Investigate its role in preventing hypertrophic scars and keloids.
Secondary Objectives:
- Assess the effect of amniotic membrane application on postoperative pain levels using the Visual Analog Scale (VAS).
- Measure patient satisfaction with cosmetic results using the Modified Hollander Wound Evaluation Scale.
Methodology:
A total of 372 participants were enrolled and randomized into two groups (1:1 ratio) using block randomization to ensure balanced allocation. The intervention group received an amniotic membrane, harvested intraoperatively from the placenta and applied directly to the cesarean incision site before closure. The control group underwent cesarean delivery without membrane application. Both groups were blinded to their assignments, and standard postoperative wound care was provided.
Participants were evaluated at multiple predefined postoperative time points (days 1, 2, 7, 40, and 6 months) for surgical site infections, wound dehiscence, scar/keloid formation, pain levels, and cosmetic satisfaction.
Significance:
This study provides evidence supporting the use of autologous amniotic membranes in obstetrics, potentially establishing a low-cost, accessible method to improve surgical outcomes and patient quality of life. If successful, these findings may have broader implications for other surgical fields and high-risk patient populations.
- Conditions
- Cesarean Section
- Being tested
- Amniotic Membrane Application
- Keywords
- Amniotic Membrane, Cesarean Section, Wound Healing, Surgical Site Infection, Postoperative Pain, Hypertrophic Scarring, Keloid Formation, Cosmetic Outcomes, Regenerative Medicine, Maternal Health
- Medical subject headings
- Surgical Wound Infection, Pain, Postoperative, Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amniotic Membrane ApplicationOther
Amniotic Membrane Application:
This intervention involves the application of an amniotic membrane harvested intraoperatively from the fetal side of the placenta during cesarean delivery. The membrane is placed directly on the incision site before surgical closure to promote wound healing and reduce complications such as infection, dehiscence, and scarring. The membrane is removed 24 hours postoperatively, and standard wound care is continued thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Amniotic Membrane Group | Experimental | Participants in this arm received an amniotic membrane application directly to the cesarean incision site during surgery. The membrane was harvested intraoperatively from the placenta and placed over the incision area before closure. It was removed 24 hours postoperatively, followed by standard postoperative wound care. Receives: Other: Amniotic Membrane Application |
| Control Group (No Intervention) | No intervention | Participants in this arm underwent standard cesarean delivery without the application of an amniotic membrane. Standard postoperative wound care was provided without any additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection (SSI)
Description: The presence of surgical site infections diagnosed based on erythema, induration, tenderness, and purulent discharge.
Scale: Binary (Yes/No)
Measured: Time Frame: Within 7 days post-surgery.
Wound Dehiscence
Description: The occurrence of wound dehiscence defined as a wound gap of less than 1 cm in depth.
Scale: Binary (Yes/No).
Measured: Time Frame: Within 7 days post-surgery.
Scar/Keloid Formation
Description: The presence of hypertrophic scars or keloids assessed visually. Scale: Binary (Yes/No).
Measured: Time Frame: At 40 days and 6 months post-surgery.
Secondary outcomes (2)
Postoperative Pain (VAS Score)
Description: Pain scores measured using the Visual Analog Scale (VAS). Scale: 0 to 10 (0 = no pain, 10 = worst pain).
Measured: Time Frame: Postoperative days 1 and 2.
Cosmetic Satisfaction
Description: Patient-reported satisfaction with the cosmetic appearance of the incision site, measured using the Modified Hollander Wound Evaluation Scale.
Scale: 0 to 6 (higher scores indicate better cosmetic outcomes).
Measured: Time Frame: At 40 days post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start20 May 2022
- Primary completion20 May 2023
- Study completion20 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel-group design, where participants are randomly assigned to one of two groups: Intervention Group: Participants receive an amniotic membrane application over the cesarean incision site. Control Group: Participants undergo cesarean delivery without amniotic membrane application. Both groups were followed simultaneously to evaluate postoperative outcomes, including surgical site infection, wound healing, pain, and cosmetic satisfaction. Randomization was performed using a block randomization method to ensure balanced group sizes. This design ensures a robust comparison between the intervention and control groups under similar conditions.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Izzet Celegen, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770946
- Sponsor's protocol ID
- 2022/22-05
- Acronym
- Amniotic Membr
- Status last verified
- Dec 2024
- First submitted
- 31 Dec 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan to Share IPD: No Plan Description: Individual participant data will not be shared due to institutional data-sharing policies and privacy concerns.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Amniotic Membrane Application on Post-Cesarean Wound Healing and Cosmetic Outcomes: a Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06770946
- Acronym / sponsor ID
- Amniotic Membr / 2022/22-05
- Conditions
- Cesarean Section
- Keywords
- Amniotic Membrane, Cesarean Section, Wound Healing, Surgical Site Infection, Postoperative Pain, Hypertrophic Scarring, Keloid Formation, Cosmetic Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 13 Jan 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.
This clinical trial evaluates the effectiveness of amniotic membrane application during cesarean delivery in reducing post-surgical complications and improving wound healing and cosmetic outcomes in women aged 18-40 undergoing their first cesarean section. The primary questions this study aims to answer are:
- Compared to standard care, Does the amniotic membrane reduce surgical site infections and wound dehiscence?
- Does the amniotic membrane improve patient satisfaction with cosmetic outcomes?
Participants were randomized into two groups: the intervention group received an amniotic membrane application over the cesarean incision site, while the control group underwent cesarean delivery without membrane application. Outcomes were assessed at predefined postoperative intervals, focusing on wound healing, pain levels, and cosmetic satisfaction.
Detailed description
This randomized, double-blind, controlled trial investigates the effectiveness of amniotic membrane application in reducing post-cesarean complications, including surgical site infections, wound dehiscence, and scar formation. The trial also assesses its impact on pain management and cosmetic outcomes in women aged 18-40 undergoing their first cesarean section. The study was conducted between May 2022 and May 2023 at Van Regional Training and Research Hospital.
The amniotic membrane, the innermost layer of the placenta, has regenerative, anti-inflammatory, and antimicrobial properties. Its application during cesarean delivery may offer a cost-effective and autologous intervention to enhance surgical outcomes and patient satisfaction.
Objectives:
Primary Objectives:
- Evaluate whether the amniotic membrane reduces surgical complications, including infections, hematoma, and wound dehiscence.
- Investigate its role in preventing hypertrophic scars and keloids.
Secondary Objectives:
- Assess the effect of amniotic membrane application on postoperative pain levels using the Visual Analog Scale (VAS).
- Measure patient satisfaction with cosmetic results using the Modified Hollander Wound Evaluation Scale.
Methodology:
A total of 372 participants were enrolled and randomized into two groups (1:1 ratio) using block randomization to ensure balanced allocation. The intervention group received an amniotic membrane, harvested intraoperatively from the placenta and applied directly to the cesarean incision site before closure. The control group underwent cesarean delivery without membrane application. Both groups were blinded to their assignments, and standard postoperative wound care was provided.
Participants were evaluated at multiple predefined postoperative time points (days 1, 2, 7, 40, and 6 months) for surgical site infections, wound dehiscence, scar/keloid formation, pain levels, and cosmetic satisfaction.
Significance:
This study provides evidence supporting the use of autologous amniotic membranes in obstetrics, potentially establishing a low-cost, accessible method to improve surgical outcomes and patient quality of life. If successful, these findings may have broader implications for other surgical fields and high-risk patient populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a parallel-group design, where participants are randomly assigned to one of two groups: Intervention Group: Participants receive an amniotic membrane application over the cesarean incision site. Control Group: Participants undergo cesarean delivery without amniotic membrane application. Both groups were followed simultaneously to evaluate postoperative outcomes, including surgical site infection, wound healing, pain, and cosmetic satisfaction. Randomization was performed using a block randomization method to ensure balanced group sizes. This design ensures a robust comparison between the intervention and control groups under similar conditions.
| Arm | Type | Receives |
|---|---|---|
| Amniotic Membrane Group | Experimental | Other: Amniotic Membrane ApplicationParticipants in this arm received an amniotic membrane application directly to the cesarean incision site during surgery. The membrane was harvested intraoperatively from the placenta and placed over the incision area before closure. It was removed 24 hours postoperatively, followed by standard postoperative wound care. |
| Control Group (No Intervention) | No intervention | –Participants in this arm underwent standard cesarean delivery without the application of an amniotic membrane. Standard postoperative wound care was provided without any additional intervention. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female participants aged 18-40 years. Undergoing their first cesarean section. Term pregnancies (≥37 weeks of gestation). Elective cesarean delivery performed under spinal anesthesia. Use of the Pfannenstiel incision method. Willing and able to provide written informed consent.
Key exclusion criteria (3 listed)
- History of previous abdominal surgeries. Presence of chronic conditions such as diabetes mellitus, hypertension, or vascular diseases.
- Pulmonary conditions or collagen tissue disorders affecting wound healing. Signs of infection during delivery. Use of medications or therapies that impair wound healing (e.g., corticosteroids, immunosuppressants).
- Known hypersensitivity to materials or methods used in the study
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 |
|---|---|---|
| Amniotic Membrane ApplicationAmniotic Membrane Application: This intervention involves the application of an amniotic membrane harvested intraoperatively from the fetal side of the placenta during cesarean delivery. The membrane is placed directly on the incision site before surgical closure to promote wound healing and reduce complications such as infection, dehiscence, and scarring. The membrane is removed 24 hours postoperatively, and standard wound care is continued thereafter. | Other | Amniotic Membrane Group |
Primary outcome
Surgical Site Infection (SSI)
Time frame: Time Frame: Within 7 days post-surgery.
Description: The presence of surgical site infections diagnosed based on erythema, induration, tenderness, and purulent discharge. Scale: Binary (Yes/No)
Wound Dehiscence
Time frame: Time Frame: Within 7 days post-surgery.
Description: The occurrence of wound dehiscence defined as a wound gap of less than 1 cm in depth. Scale: Binary (Yes/No).
Scar/Keloid Formation
Time frame: Time Frame: At 40 days and 6 months post-surgery.
Description: The presence of hypertrophic scars or keloids assessed visually. Scale: Binary (Yes/No).
2 secondary outcomes
Postoperative Pain (VAS Score)
Time frame: Time Frame: Postoperative days 1 and 2.
Cosmetic Satisfaction
Time frame: Time Frame: At 40 days post-surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No. Plan to Share IPD: No Plan Description: Individual participant data will not be shared due to institutional data-sharing policies and privacy concerns.
Related trials for Cesarean Section
Not yet recruiting
Esketamine Combined With Transcutaneous Electrical Acupoint Stimulation on Postoperative Recovery Quality After Elective Cesarean Section
Cesarean Section (MeSH: D002585), Postoperative Pain After Cesarean Section
Not yet recruitingObservational study
Early Heart Rate Variability and Sleep and Quality of Recovery After Cesarean Delivery
Recovery of Function, Postoperative Period
Not yet recruiting
Virtual Reality for Anxiety and Birth Satisfaction During Elective Cesarean Section
Anxiety, Cesarean Section
RecruitingPhase 4
Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
Cesarean Delivery, Cesarean Delivery; Neuraxial Opioids
Recruiting
Reducing Chronic Pain Following Cesarean Delivery
Chronic Pain, Cesarean Section Complications
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 Amniotic Membrane Application in people with Cesarean Section, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 13 Jan 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Surgical Site Infection (SSI) (time frame: Time Frame: Within 7 days post-surgery.). The study lists 3 primary outcomes in all. 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 13 Jan 2025.