The Effect of Amniotic Membrane Application on Post-Cesarean Wound Healing and Cosmetic Outcomes

Yuzuncu Yıl University

Status: Completed

Conditions: Cesarean Section

Treatments: Other: Amniotic Membrane Application

Study type: Interventional

Funder types: Other

Identifiers

NCT06770946

2022/22-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 372 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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372 participants in 2 patient groups

Amniotic Membrane Group

Experimental group

Description:

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.

Treatment:

Other: Amniotic Membrane Application

Control Group (No Intervention)

No Intervention group

Description:

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.