NCT02179723

Brief Summary

This clinical study aims to assess whether the benefits of using Leukosan Adhesive on trocar incisions are greater or equivalent to those provided by the standard therapy of transcutaneous sutures. In particular, it tests the long-term cosmetic result after 3 months, the safety and tolerance, as well as the practicality of treatment with Leuksan Adhesive. An open, randomised, controlled, prospective, single location, clinical study of women of ages between 18 and 60 years within the time span of March 2013 and April 2013.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2014

Completed
Last Updated

July 2, 2014

Status Verified

June 1, 2014

Enrollment Period

1.1 years

First QC Date

June 30, 2014

Last Update Submit

June 30, 2014

Conditions

Wound Healing Cosmetic Result

Keywords

wound healingcosmetic resultstrocar incision

Outcome Measures

Primary Outcomes (1)

  • Patient's satisfaction with cosmetic appearance/result of the wound

    The primary outcome was the satisfaction of the patients with the cosmetic result of the wound healing after 3 months. This was measured by a visual analogue scale. In order to validate this result, an additional known wound assessment instrument, an ordinal scaled index, was implemented and the assessment of independent assessors was called on.

    3 months post operation

Secondary Outcomes (3)

  • The incidence of complication

    7-12 days post-operation

  • Intensity of pain

    7-12 days post-operation

  • Investigator's assessment of cosmetic outcome

    At 3 months post-operation

Study Arms (2)

Leukosan Adhesive

EXPERIMENTAL

Leukosan Adhesive applied to one wound (left or right)

Device: Leukosan AdhesiveDevice: Transcutaneous suture

Transcutaneous suture

ACTIVE COMPARATOR

Transcutaneous suture applied to second wound (left or right)

Device: Leukosan AdhesiveDevice: Transcutaneous suture

Interventions

Leukosan AdhesiveDEVICE

Leukosan adhesive applied to one wound

Leukosan AdhesiveTranscutaneous suture
Transcutaneous sutureDEVICE

Transcutaneous suture applied to one wound

Leukosan AdhesiveTranscutaneous suture

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female between 18 and 60
  • Undergone laparoscopic operation with 2 mirror image trocar incisions
  • Willing to attend examination at clinic at 7-12 days and 10-14 weeks
  • Signed agreement by participant

You may not qualify if:

  • Length of laparoscopic operation more than 2 hours
  • Hospitalisation due to complications
  • Circumstances leading to difference in trocar incisions
  • Existing scar less than 3 cm from the operation point
  • Diabetic condition melitis HbA1c\>9mg/d
  • Known allergy to tissue adhesive
  • Participation in another study within 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tagesklinik Altonaer Strasse

Hamburg, 20357, Germany

Location

Related Publications (6)

  • Rosen DM, Carlton MA. Skin closure at laparoscopy. J Am Assoc Gynecol Laparosc. 1997 May;4(3):347-51. doi: 10.1016/s1074-3804(05)80226-9.

    PMID: 9154784BACKGROUND

  • Matin SF. Prospective randomized trial of skin adhesive versus sutures for closure of 217 laparoscopic port-site incisions. J Am Coll Surg. 2003 Jun;196(6):845-53. doi: 10.1016/s1072-7515(03)00119-4.

    PMID: 12788419BACKGROUND

  • Buchweitz O, Wulfing P, Kiesel L. A prospective randomized trial of closing laparoscopic trocar wounds by transcutaneous versus subcuticular suture or adhesive papertape. Surg Endosc. 2005 Jan;19(1):148-51. doi: 10.1007/s00464-004-9043-2. Epub 2004 Nov 18.

    PMID: 15549624BACKGROUND

  • Chen K, Klapper AS, Voige H, Del Priore G. A randomized, controlled study comparing two standardized closure methods of laparoscopic port sites. JSLS. 2010 Jul-Sep;14(3):391-4. doi: 10.4293/108680810X12924466006729.

    PMID: 21333194BACKGROUND

  • Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.

    PMID: 3450848BACKGROUND

  • Buchweitz O, Frye C, Moeller CP, Nugent W, Krueger E, Nugent A, Biel P, Juergens S. Cosmetic outcome of skin adhesives versus transcutaneous sutures in laparoscopic port-site wounds: a prospective randomized controlled trial. Surg Endosc. 2016 Jun;30(6):2326-31. doi: 10.1007/s00464-015-4474-5. Epub 2015 Oct 1.

    PMID: 26428200DERIVED

Study Officials

  • Olaf Buchweitz, Priv.Doz.

    Tagesklinik Altonaer Strasse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Scientific Affairs, Wound Care

Study Record Dates

First Submitted

June 30, 2014

First Posted

July 2, 2014

Study Start

March 1, 2012

Primary Completion

April 1, 2013

Study Completion

July 1, 2013

Last Updated

July 2, 2014

Record last verified: 2014-06

Locations

DE(1)