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resection of a layer of skin and decreasing surgical wound infection and dehiscence

Comparing the effects of conventional surgery with resection of a layer of dermis and epidermis on decreasing the rate of surgical wound infection and dehiscence in high risk patients operated for obstetric or gynecologic conditions

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201206165485N3
Enrollment
740
Registered
2013-02-03
Start date
2012-07-05
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

wound infection. Disruption of operation wound, Infection of obstetric surgical wound

Interventions

Intervention 1: In the study group, at the end of the operation, that is done by an obstetrics and gynecology resident, after closing the fascia, a layer of 0,5-1 cm of the skin and subcutaneous tissu
Treatment - Surgery
In the study group, at the end of the operation, that is done by an obstetrics and gynecology resident, after closing the fascia, a layer of 0,5-1 cm of the skin and subcutaneous tissue is excised wit
In the control group the skin and subcutaneous tissue is closed routinely without excising them.

Sponsors

Vice chancellor for research, Women's Reproductive Health Research Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: patient with moderate to severe obesity (BMI=30-40) , subcutaneous fat thickness over 5 cm, diabetes, suppressed immunity, systemic and chronic illnesses, cesarean section for meconium defecation, ruptured membrane, prolonged labor and dystocia, cesarean lasting more than 2 hours, gynecologic operations lasting more than 3 hours, presence of scars in the operative field Exclusion criteria: patient with bleeding illnesses, cardiovascular diseases or critical conditions requiring to urgently terminate the operation, active infection like bacteremia, septicemia, pelvic or abdominal abscess, chorioamnionitis, acute PID, severe bleeding, cancer

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Wound infection. Timepoint: third and tenth of the operation. Method of measurement: physical examination.

Secondary

MeasureTime frame
Wound dehiscence. Timepoint: third and tenth day of the operation. Method of measurement: physical examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNazli Navali

Tabriz University of Medical Sciences

navalin@tbzmed.ac.ir+98 41 1334 5416

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026