The Effect of Amniotic Membrane Application on Post-Cesarean Wound Healing and Cosmetic Outcomes
NCT ID: NCT06770946
Last Updated: 2025-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
372 participants
INTERVENTIONAL
2022-05-20
2023-05-20
Brief Summary
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1. Compared to standard care, Does the amniotic membrane reduce surgical site infections and wound dehiscence?
2. 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.
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Detailed Description
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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:
1. Evaluate whether the amniotic membrane reduces surgical complications, including infections, hematoma, and wound dehiscence.
2. Investigate its role in preventing hypertrophic scars and keloids.
Secondary Objectives:
1. Assess the effect of amniotic membrane application on postoperative pain levels using the Visual Analog Scale (VAS).
2. 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
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
DOUBLE
Study Groups
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Amniotic Membrane Group
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.
Amniotic Membrane Application
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.
Control Group (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.
No interventions assigned to this group
Interventions
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Amniotic Membrane Application
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
18 Years
40 Years
FEMALE
No
Sponsors
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Yuzuncu Yıl University
OTHER
Responsible Party
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Izzet Celegen
Assistant professor
Locations
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Van Regional Training and Research Hospital
Van, Van, Turkey (Türkiye)
Countries
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Other Identifiers
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2022/22-05
Identifier Type: -
Identifier Source: org_study_id
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