Clinical Trials Logo
  1. Home
  2. Complications; Cesarean Section
  3. NCT01891006

Intervention for Postpartum Infections Following Caesarean Section — APIPICS  

Surgical Wound Infection Clinical Trial

Official title:
Intervention for Postpartum Infections Following Caesarean Section - a Randomized Controlled Trial

Clinical Trial Summary

The purpose of this study is to examine whether Negative Pressure Wound Therapy is an effective wound treatment compared to conventional wound treatment in the period of time from reoperation to re-suturing in women having surgical wound rupture after Caesarean Section.

Clinical Trial Description

This study is a non-blinded randomized controlled trial and a concurrent Health Economic. The study examines the effect on wound healing using NPWT compared with conventional wound treatment in women, who experience spontaneous dehiscence or where a surgeon deliberately opens the wound after Caesarean Section (CS).

Women, who have given informed consent, will be randomized to either intervention or control group via a computer-generated randomization program. It is not possible to blind either participants or therapists. The analysis will be carried out on an intention to treat basis.

Women with post-CS wound infection will be hospitalized and the wound will be reopened and cleaned under general anaesthesia. In the intervention group women will be treated with NPWT. The change of wound dressing on the second day takes place in the obstetrical or plastic surgery ward. On the fourth day, the NPWT material will be removed and the wound evaluated before re-suturing. In the control group the wound will be treated with a hydrofiber or alginate dressing. Changes of wound dressing will take place on the second and fourth days as in the intervention group. In both groups, when the wound is evaluated on the second and fourth day, it will be described and measured (depth, width, length). After four days of treatment, the wound will be re-sutured in both groups. It is expected that some wounds are not suitable for re-suturing on the fourth day. If a woman does not want to participate, she will receive the conventional treatment, which corresponds to the treatment in the control group. Women, who do not wish to participate, will be asked for permission to use their data in the analysis. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01891006
Study type Interventional
Source Odense University Hospital
Contact
Status Completed
Phase N/A
Start date May 2011
Completion date July 2015
View Details
See also
  Status Clinical Trial Phase
Completed NCT05529173 - Povidone-Iodine for Nasal Decolonization Phase 4
Recruiting NCT03295955 - Comparing Efficacy of Postoperative Oral Antibiotic Use in Trans-Oral Thyroidectomy N/A
Not yet recruiting NCT05276687 - Efficacy of Diluted Betadine vs Antibiotic Installation Before Surgical Wound Closure in Prevention of Post Cardiac Surgery Wound Infection Phase 4
Completed NCT02776774 - Topical Antibiotic Treatment for Spine Surgical Site Infection
Terminated NCT00386477 - Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial N/A
Not yet recruiting NCT03872544 - Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Recruiting NCT05077592 - Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections Phase 4
Completed NCT03148067 - Incidence and Risk Factors for Surgical Site Infection After Intramedullary Nailing of Femoral and Tibial Fractures
Enrolling by invitation NCT03880188 - Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Completed NCT01890720 - Incisional Negative Pressure Wound Therapy for Prevention of Postoperative Infections Following Caesarean Section N/A
Recruiting NCT06319235 - Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG® Phase 1/Phase 2
Completed NCT02919410 - Bacterial Colonization With and Without Iodophor-impregnated Adhesive Drapes in Hip Surgery: a Prospective, Randomized Trial N/A
Completed NCT02020018 - Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection N/A
Completed NCT01741649 - Clorhexidine Versus Povidone for the Prevention of Surgical Site Infection After Cesarean Section N/A
Not yet recruiting NCT01457859 - Effectiveness of Triclosan Coated Sutures in Preventing Leg Wound Infection After Coronary Artery Bypass Surgery Phase 4
Completed NCT01340534 - Supplemental Perioperative Oxygen to Reduce the Incidence of Post-cesarean Wound Infection Phase 3
Completed NCT03365219 - Alexis O-Ring Wound Retractor for the Prevention of Post-cesarean Surgical Site Infections N/A
Completed NCT01026259 - Local Warming of Surgical Incisions Phase 3
Completed NCT03574090 - Study the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Infection in Colorectal Surgery Phase 4
Completed NCT03199911 - Topical Antibiotic Prophylaxis for Eyelids Phase 4