Clinical trial NCT06770946: The Effect of Amniotic Membrane Application on Post-Cesarean Wound Healing and Cosmetic Outcomes
Official title: The Effect of Amniotic Membrane Application on Post-Cesarean Wound Healing and Cosmetic Outcomes: a Double-Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Keywords: Amniotic Membrane
Cesarean Section
Wound Healing
Surgical Site Infection
Postoperative Pain
Hypertrophic Scarring
Keloid Formation
Cosmetic Outcomes
Regenerative Medicine
Maternal Health
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 372
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

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:

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Surgical Site Infection (SSI)
timeFrame: Time Frame: Within 7 days post-surgery.
measure: Wound Dehiscence
timeFrame: Time Frame: Within 7 days post-surgery.
measure: Scar/Keloid Formation
timeFrame: Time Frame: At 40 days and 6 months post-surgery.
Secondary outcomes:
measure: Postoperative Pain (VAS Score)
timeFrame: Time Frame: Postoperative days 1 and 2.
measure: Cosmetic Satisfaction
timeFrame: Time Frame: At 40 days post-surgery.
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Regional Training and Research Hospital
Study officials:
References: