Treatment Study of Vacuum Assisted Closure for Postsurgical Subcutaneous Abdominal Wound Healing Impairments

NCT01528033 | Completed Results DMC

• 2 other identifiers: VAC2010-5600000648
• Study Type: interventional
• Target: 539
• Locations: 2 countries
• Sites: 15

Brief Summary

This clinical study is performed in several German, Dutch and Belgian hospitals to evaluate the efficacy of Vacuum Assisted Closure® (V.A.C.®) for the treatment of postsurgical abdominal wound healing impairments after surgery. Therefore the underlying layer of fibrous tissue that permeates the internal organs must be intact. Main outcome measure is the time until complete wound closure that sustained for a minimum of 14 days. Furthermore the therapy options will be examined regarding several other clinical, safety, patient reported and economic parameters. Patients will be assigned equally and by chance to both treatment groups. Study participants as well as the attending doctors and nurses will be informed about the assignment to the respective treatment arm. The primary outcome measure and some of the secondary parameters like reappearance of the wound and the development of the wound size over time, examined within an active study treatment time of 42 days, will be photographed and analysed under the use of a central computer system. The central analysing personal will not be informed about patient details or therapy allocation. Patients with at first closed belly wounds with wound healing disorder in the postoperative course after surgery without an opening of the underlying layer of fibrous tissue are eligible to be included in the trial if the diagnosis of a wound healing impairment in the postoperative course is manifested as a wound with spontaneous dehiscence, a wound that requires an active reopening of the suture by the treating physician or a wound that cannot be closed by primary intention and requires further treatment to achieve permanent closure. Study participants will be selected and enrolled within clinical surgical departments which provide the respective personal, structural and scientific background for the conduction of the trial project. Trial therapy will be started in-hospital and may be continued in ambulatory care. It is very important to examine the therapy options also in the ambulant care setting thus study participants with good health who are able to continue the specific wound treatment in ambulant should be transferred to the ambulant service as soon as possible.

Conditions

Wound Healing Disorder; Impaired Wound Healing; Abdominal Wound Healing Disorder; Abdominal Wound Healing Impairment; Acute Postsurgical Subcutaneous Wound

Keywords

surgical wound; wound healing disorder; Wound healing impairment; post surgical wound healing disorder; abdominal wound healing impairment; Vacuum Assisted Closure; negative pressure wound therapy

Outcome Measures

Primary Outcomes (1)

• Time to Complete Wound Closure

  Time (number of days) to achieve complete wound closure verified by photo documentation and blinded, computer-based wound quality assessment as well as wound closure confirmation after 14 consecutive days (14 days -0 / + 3) Complete wound closure is defined as: 100% epithelialization No drainage from the wound No need for adjuvant therapy or dressing No presence of sutures

  42 days

Secondary Outcomes (2)

• Incidence of Confirmed and Verified Wound Closure

  42 days

• Recurrence

  132 days

Study Arms (2)

Vacuum Assisted Closure®

EXPERIMENTAL

Negative pressure wound therapy

Device: Vacuum Assisted Closure®

Standard conventional wound therapy

ACTIVE COMPARATOR

According to institutional clinical standards

Other: Standard conventional wound therapy

Interventions

Vacuum Assisted Closure® DEVICE

Vacuum Assisted Closure® (V.A.C.®) Therapy within a maximum study treatment time of 42 days. VAC® Therapy Systems used within the trial are ActiV.A.C.®, InfoV.A.C.®, V.A.C. Freedom®, V.A.C. Via® and VAC Ulta®. All used systems are equally eligible for the treatment of subcutaneous abdominal wounds and should be used according to availability and local preferences within the trial site. Systems differ regarding user surface and display and processing of data. For the treatment of subcutaneous abdominal wounds the V.A.C.® Granufoam Dressing (size medium and big) is recommended.

Also known as: Negative Pressure Wound Therapy

Vacuum Assisted Closure®

Standard conventional wound therapy OTHER

Standard conventional wound therapy (SCWT) according to institutional clinical standards within a maximum study treatment time of 42 days

Standard conventional wound therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Post-surgical subcutaneous abdominal wound healing impairment

You may not qualify if:

• Age \< 18
• Noncompliance with study procedures, visit schedule and follow up
• Pregnancy
• Present or nonclosable defect of the abdominal fascia
• Any pre-existing or ongoing organ system failure, that cannot be stabilized or solved by appropriate medical treatment
• Necrotic tissue with eschar present
• Non-enteric and unexplored fistulas
• Malignancy of the wound
• Use of any other device based on the principle of negative pressure wound therapy on the study wound within ≤ 8 days prior to screening
• Competing therapies or procedures
• Simultaneous participation in other clinical trials

Sponsors & Collaborators

• University of Witten/Herdecke: lead
• KCI Europe Holding B.V.: collaborator

Study Sites (15)

UZ Brussel

Brussels, 1090, Belgium

Location

Department of Abdominal Surgery Gasthuisberg University Hospital

Leuven, 3000, Belgium

Location

Sana Klinikum Lichtenberg (Berlin)

Berlin, 10365, Germany

Location

Unfallkrankenhaus Berlin Klinik für Allgemein- und Viszeralchirurgie

Berlin, 12683, Germany

Location

St. Josef-Hospital gGmbH Universitätsklinikum der Ruhr-Universität Bochum

Bochum, 44791, Germany

Location

Universitätsmedizin Göttingen

Göttingen, 37075, Germany

Location

Universitätsklinikum des Saarlandes, Klinik für Allgemeine Chirurgie, Viszeral-, Gefäß- und Kinderchirurgie

Homburg, 66421, Germany

Location

UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität

Mainz, 55131, Germany

Location

Universitätsmedizin Mannheim Medizinische Fakultät Mannheim der Universität Heidelberg Chirurgische Klinik

Mannheim, 68167, Germany

Location

Chirurgische Klinik und Poliklinik, Klinikum rechts der Isar

München, 81675, Germany

Location

Ruppiner Kliniken GmbH

Neuruppin, 16816, Germany

Location

Klinikum Ernst von Bergmann, Klinik für Allgemein- und Visceralchirurgie

Potsdam, 14467, Germany

Location

Diakoniekrankenhaus Rotenburg

Rotenburg (Wümme), 27356, Germany

Location

Thüringen-Kliniken "Georgius Agricola" GmbH

Saalfeld, 07318, Germany

Location

GRN-Klinik Sinsheim, Allgemein- und Viszeralchirurgie

Sinsheim, 74889, Germany

Location

Related Publications (3)

• Seidel D, Lefering R, Neugebauer EA. Treatment of subcutaneous abdominal wound healing impairment after surgery without fascial dehiscence by vacuum assisted closure (SAWHI-V.A.C.(R)-study) versus standard conventional wound therapy: study protocol for a randomized controlled trial. Trials. 2013 Nov 20;14:394. doi: 10.1186/1745-6215-14-394.

  PMID: 24252551 BACKGROUND

• Seidel D, Diedrich S, Herrle F, Thielemann H, Marusch F, Schirren R, Talaulicar R, Gehrig T, Lehwald-Tywuschik N, Glanemann M, Bunse J, Huttemann M, Braumann C, Heizmann O, Miserez M, Kronert T, Gretschel S, Lefering R. Negative Pressure Wound Therapy vs Conventional Wound Treatment in Subcutaneous Abdominal Wound Healing Impairment: The SAWHI Randomized Clinical Trial. JAMA Surg. 2020 Jun 1;155(6):469-478. doi: 10.1001/jamasurg.2020.0414.

  PMID: 32293657 RESULT

• Seidel D; SAWHI study group. Ambulatory negative pressure wound therapy of subcutaneous abdominal wounds after surgery: results of the SAWHI randomized clinical trial. BMC Surg. 2022 Dec 12;22(1):425. doi: 10.1186/s12893-022-01863-x.

  PMID: 36503505 DERIVED

Related Links

• Sponsor

MeSH Terms

Conditions

Surgical Wound

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Results Point of Contact

• Title: Dörthe Seidel
• Organization: Witten/Herdecke University

Doerthe.Seidel@uni-wh.de

00492219895731

Study Officials

• Doerthe Seidel

  Witten / Herdecke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interim Scientific Leader of the Centre for Clinical Trials and Innovation

Study Record Dates

• First Submitted: February 2, 2012
• First Posted: February 7, 2012
• Study Start: August 2, 2011
• Primary Completion: March 14, 2018
• Study Completion: June 11, 2018
• Last Updated: June 25, 2020
• Results First Posted: June 25, 2020

Record last verified: 2020-06

Locations

BE (2); DE (13)