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PDS vs Polyamide for Midline Abdominal Closure (PPMAC)

This study has been terminated.
(Unacceptable incidence of wound dehiscence in the PDS group)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00514566
First Posted: August 10, 2007
Last Update Posted: August 10, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Christian Medical College and Hospital, Ludhiana, India
  Purpose
Within the last decade the customary trend of using non absorbable sutures has changed, with numerous studies and meta-analyses advocating the use of slowly absorbable sutures, claiming comparable wound strength with significantly lower incidence of wound complications. It was the objective of this randomized clinical trial to compare two universally accepted suture materials, the non-absorbable Nylon and the slowly absorbable Polydioxanone for midline abdominal closure in the Indian context.

Condition Intervention
Laparotomy Device: Suture for midline abdominal closure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Is Polydioxanone 'THE' Suture of Choice for Midline Abdominal Closure? Results of a Prospective Randomized Clinical Trial

Further study details as provided by Christian Medical College and Hospital, Ludhiana, India:

Primary Outcome Measures:
  • Wound Complications associated with suture material used for closure- Wound Dehiscence, Wound Infection, Incisional Hernia, Suture Sinus, Scar Pain [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Factors independent of suture materials responsible for wound complications such as age, gender, type of surgery, degree of contamination, surgeon, and presence of a stoma [ Time Frame: 2 years ]

Enrollment: 64
Study Start Date: October 2004
Study Completion Date: April 2006
Arms Assigned Interventions
Active Comparator: 1
Surgical Patient undergoing midline laparotomy closure
Device: Suture for midline abdominal closure
closure with Polyamide or Polydioxanone
Other Name: Ethicon Inc., Loop no. 1, 150 cm suture length

Detailed Description:

64 patients undergoing midline laparotomy were allocated, using block randomization, to mass closure of the abdominal wall with continuous polyamide (34 patients) or continuous polydioxanone (30 patients).

There was an alarmingly higher incidence of wound dehiscence in the PDS group requiring secondary suturing (Nylon 0; PDS 5). Mid-way through the trial, an interim analysis was performed which revealed an unacceptably high incidence of wound dehiscence in the PDS group. This necessitated a premature curtailment of the study. There was, however, a statistically significantly higher incidence of scar pain in the Nylon group (Nylon 9; PDS 1).

There is a need for a study with larger series, and PDS as a choice of suture for midline wound closure cannot be recommended.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients above 12 years of age undergoing midline abdominal fascial closure using a continuous technique in the Department of Surgery, Christian Medical College and Hospital

Exclusion Criteria:

  • All patients under 12 years of age
  • Gynaecological operations
  • Abdominal wall hernia repair
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514566


Locations
India
Christian Medical College and Hospital
Ludhiana, Punjab, India, 141008
Sponsors and Collaborators
Christian Medical College and Hospital, Ludhiana, India
Investigators
Study Chair: Rajeev Kapoor, MS(Gen Surg) Christian Medical College and Hospital, Ludhiana, India
  More Information

ClinicalTrials.gov Identifier: NCT00514566     History of Changes
Other Study ID Numbers: ChristianMCLudhiana
First Submitted: August 8, 2007
First Posted: August 10, 2007
Last Update Posted: August 10, 2007
Last Verified: August 2007

Keywords provided by Christian Medical College and Hospital, Ludhiana, India:
Polyamide
Polydioxanone
Midline
Abdominal
Closure