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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:
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.
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:
Secondary Objectives:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amniotic Membrane Application | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Site Infection (SSI) | Description: The presence of surgical site infections diagnosed based on erythema, induration, tenderness, and purulent discharge. Scale: Binary (Yes/No) | 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). | Time Frame: Within 7 days post-surgery. |
| Scar/Keloid Formation | Description: The presence of hypertrophic scars or keloids assessed visually. Scale: Binary (Yes/No). | Time Frame: At 40 days and 6 months post-surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain (VAS Score) | Description: Pain scores measured using the Visual Analog Scale (VAS). Scale: 0 to 10 (0 = no pain, 10 = worst pain). | Time Frame: Postoperative days 1 and 2. |
| Cosmetic Satisfaction |
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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
This study is limited to individuals with a biological sex of female, as it involves cesarean delivery outcomes
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Van Regional Training and Research Hospital | Van | Van | 65090 | Turkey (Türkiye) |
Plan to Share IPD: No Plan Description: Individual participant data will not be shared due to institutional data-sharing policies and privacy concerns.
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D010149 | Pain, Postoperative |
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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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.
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No additional parties are masked beyond the Participant and Outcomes Assessor.
|
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).
| Time Frame: At 40 days post-surgery. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D002921 | Cicatrix |
| D005355 | Fibrosis |