OPTIWOUND: Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy

• Sponsor: Centro Hospitalar do Tâmega e Sousa (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05716490
• Collaborator: (none)
• Enrollment: 93
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 6.6

Study Details

Study Description

Brief Summary

The purpose of this study is to find differences in rates of surgical site infections following emergency laparotomy with the use of two different incisional negative pressure wound therapy (iNPWT)devices.

Condition or Disease	Intervention/Treatment	Phase
Surgical Site Infection; Surgical Wound; Surgical Wound Infection; Surgical Complication; Surgical Wound Dehiscence; Surgical Wound Haemorrhage; Surgical Wound, Healed	Device: Incisional negative pressure wound therapy; Other: Control group - standard wound dressing	N/A

Detailed Description

A multi-arm, randomized, single institution trial was conducted. All patients proposed for emergency laparotomy for different etiologies where considered eligible. Patients were enrolled following signature of informed consent.

Excluded from this group were patients with recent previous interventions (laparotomy or minimally invasive surgery), patients not wishing a iNPWT device or patients with specific contraindications to any device.

Later where excluded from the study patients with class IV Center for disease control wound type, patients on laparostomy, Intraoperative diagnosis of irreversible disease (Ex: Extensive mesenteric ischemia).

Following enrollment patients were randomized to 3 groups - control group with standard dressings; PICO group with Pico® (Smith & Nephew Inc, Andover, MA) dressing and Prevena group using Prevena® (KCI USA, Inc., San Antonio, TX) dressing.

Following admission the patients were monitored for surgical site occurrences and other complications by the investigation team until discharge. Subsequent 2 week post-operative evaluation (if patient had been discharged) was carried out in outpatient.

A final consultation was made 30 days postoperatively.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 93 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients are enrolled chronologically at the time of surgery into a slot of a previously randomized table with the 3 interventional armsPatients are enrolled chronologically at the time of surgery into a slot of a previously randomized table with the 3 interventional arms
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy: A Multi-arm Randomized Prospective Trial
• Actual Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard Control group which will cover surgical wound with conventional wound dressing	Other: Control group - standard wound dressing; Covering of surgical wound with standard wound dressing
Experimental: PICO Group that will use Pico® device for wound dressing	Device: Incisional negative pressure wound therapy; Application of negative pressure wound therapy for prophylaxis of surgical site occurrences
Experimental: PREVENA Group that will use Prevena® device for wound dressing	Device: Incisional negative pressure wound therapy; Application of negative pressure wound therapy for prophylaxis of surgical site occurrences

Outcome Measures

Primary Outcome Measures

1. Surgical site infection [30 days]

   Surgical site infection following emergency laparotomy

Secondary Outcome Measures

1. Surgical site occurrences [30 days]

   Seroma, hematoma, wound dehiscence

Other Outcome Measures

1. Length of stay [30 days]

   post-operative length of stay

2. Reinterventions [30 days]

3. Adverse events related to devices [30 days]

4. Surgical complications [30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All patients proposed for emergency laparotomy

Exclusion Criteria:

• Class IV center for disease control wound classification

• Contra-indication for iNPWT

• Irreversible disease diagnosis with expected short term mortality

• Need for a staged procedure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro Hospitalar do Tâmega e Sousa	Penafiel	Porto	Portugal

Sponsors and Collaborators

• Centro Hospitalar do Tâmega e Sousa

Investigators

• Principal Investigator: Marcelo J Costa, MD, Centro Hospitalar do Tâmega e Sousa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marcelo José Maia Azevedo Costa, Principal investigator, general surgery resident, Centro Hospitalar do Tâmega e Sousa
• ClinicalTrials.gov Identifier: NCT05716490
• Other Study ID Numbers: 29/2022
• First Posted: Feb 8, 2023
• Last Update Posted: Feb 10, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Marcelo José Maia Azevedo Costa, Principal investigator, general surgery resident, Centro Hospitalar do Tâmega e Sousa: iNPWT; Incision negative pressure wound therapy; emergency laparotomy; general surgery; surgical site infection
• Additional relevant MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection; Wound Infection; Emergencies; Hemorrhage; Surgical Wound Dehiscence; Wounds and Injuries; Surgical Wound

Study Results

No Results Posted as of Feb 10, 2023