Prophylactic Negative Pressure Wound Therapy for High Risk Laparotomy Wounds. A Randomized Prospective Clinical Trial.

St. Borbala Hospital

Status: Terminated

Conditions: Surgical Site Infection; Surgical Wound; Wound Dehiscence, Surgical; Dehiscence of Internal Surgical Wound

Treatments: Device: Prophylactic negative pressure wound dressing after laparotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03716687

OGYÉI/15347-9/2018

Details and patient eligibility

About

Negative pressure wound closure technique (NPWT) has been widely introduced in different clinical settings. Most of the studies report it as an effective and cost-effective method to treat complicated surgical wounds or even open abdomen.

NPWT as a prophylactic effort to prevent complications of high risk surgical wounds has recently been introduced, but the concept is still lacking clinical evidence in terms of clinical effectiveness and cost effectiveness.

In this randomized, multi centric study investigators aim to compare prophylactic negative pressure wound closure (ciNPWT) with traditional, dry wound dressing at high infection risk laparotomy wounds.

Full description

The aim is to compare ciNPWT (closed incisional negative pressure wound dress) technique to the traditional, dry wound dressing technique at high infection risk laparotomy wounds.

Control arm will be treated "as usual": sterile gauze or high-absorbing surgical wound dress.

Experimental arm will be dressed with: one layer of silver-containing, impregnated mesh laxer (Atrauman® Ag - Hartmann) directly placed on the primary closed wound, one layer of alcohol-soaked foam (VivanoMed® White Foam - Hartmann) and sufficient-size sealant film (Hydrofilm® - Hartmann).

A negative pressure of -90 Hgmm will be administered in a continuous mode over 5 days postoperatively.

Surgical site infection and abdominal wall dehiscence rate will be assessed, as well as cost effectiveness will be calculated at both arms.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• High risk laparotomy patients. SSI risk at least 3x higher than normal rate (6-8%)
• Surgical wound type III or IV..

Exclusion criteria

• Patients not giving informed consent.
• Patients requiring open abdominal wound care.
• Patients with abdominal wall malignancy,
• Patients with peritoneal carcinomatosis,
• Patients who are planned for second look laparotomy within 5 days,
• Patients with less thank 3 month life expectancy.
• Patients who are operated with existing wound infection

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

ciNPWT

Experimental group

Description:

Prophylactic negative pressure wound dress (Hartmann) is set up for 5 days right after operation. Continous -90 Hgmm negative pressure mode selected. No change of wound dress until 5 days completed.

Treatment:

Device: Prophylactic negative pressure wound dressing after laparotomy

Traditional wound dressing

No Intervention group

Description:

Control group with traditional, dry laparotomy wound dressing.