Clinical trial NCT06558240: To Explore the Effectiveness and Feasibility of HERADERM Hydrogel Wound Dressing on Caesarean Section Surgical Site
Official title: To Explore the Effectiveness and Feasibility of HERADERM Hydrogel Wound Dressing on Caesarean Section Surgical Site
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section
Surgical Wound
Surgical Wound Infection
Wounds and Injuries
Keywords: cesarean section
wound healing
HERADERM Hydrogel Wound Dressing (Sterile)
surgical site infection
wound care
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2024-08-16
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects going to have cesarean section in Taipei Veterans General Hospital.

Brief summary: The wound of cesarean section involves multiple layers of tissue and often cause significant postoperative pain. The epidermal wound typically heals within 1 to 2 weeks after surgery. In current clinical practice, advanced wound dressings are commonly used for postoperative wound care. The theory of moist wound healing was first proposed by Winter in 1962, advocating that maintaining a moist environment around the wound can accelerate the healing process.

HERADERM Hydrogel Wound Dressing (Sterile) was approved by the Taiwan FDA in 1999. Although HERADERM Hydrogel Wound Dressing (Sterile) are frequently used clinically for post-cesarean section wound care, there have been no comprehensive reports evaluating the effectiveness and clinical application of the dressings to date. The purpose of this study is to explore the effectiveness and feasibility of HERADERM Hydrogel Wound Dressing on caesarean section surgical site and to provide user experience and clinical data for reference by patients and clinical personnel.

Detailed description: In this observational, prospective, single-arm study. We aimed to explore the effectiveness and feasibility of HERADERM Hydrogel Wound Dressing (Sterile) on caesarean section surgical site. Written informed consent are obtained before subjects participate in the study. Eligible subjects will be taken initial wound photos and use experimental dressings for postoperative wound care after closure of caesarean section wound site. To evaluate the clinical applicability of the experimental dressings, wound healing assessments will be conducted by independent study nurse during the postoperative period, hospitalization, and follow-up visits. Information of pain intensity experienced by subjects during dressing removal will be collected. Additionally, satisfaction surveys based on subjects' experiences of wearing and changing the experimental dressings will also be collected during the hospitalization and follow-up visits.

Eligibility criteria: Inclusion Criteria:

1. Age over 18, scheduling for a transverse incision cesarean section, and using HERADERM Hydrogel Wound Dressing (Sterile) for wound care at the end of the surgery.
2. Gestational age over 37 weeks on the day of the cesarean section.
3. Body mass index (BMI) less than 35 kg/m² on the day of the cesarean section.
4. Subjects must be able to comply with follow-up wound care visits and subsequent monitoring.

Exclusion Criteria:

1. Subjects unwilling to sign the consent form or with poor compliance.
2. Currently suffering from severe immune-related skin diseases, such as severe urticaria, generalized eczema, pemphigus, lupus erythematosus, etc.
3. Using medications that affect wound healing (e.g., glucocorticoids, anticoagulants and immunosuppressive drugs).
4. Subjects were deemed unsuitable for participation by investigator, such as uncontrolled infection and conditions that interfere with wound healing.

Primary outcomes:
measure: REEDA scale
timeFrame: Assessing on post-operative day 2, 4 & 11
measure: Percentage of surgical wound infection
timeFrame: Assessing on post-operative day 2, 4 & 11 if there are any surgical site infection
Secondary outcomes:
measure: Percentage of allergic reaction to experimental dressings
timeFrame: Within 11 days after surgery
measure: Intensity of pain during dressing removal
timeFrame: Assessing on post-operative day 2, 4 & 11
measure: Incidence of adverse events
timeFrame: Within 11 days after surgery
measure: Number of dressing change
timeFrame: Within 11 days after surgery
measure: Satisfaction survey
timeFrame: Assessing on post-operative day 2, 4 & 11
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Chia-Hao Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: