PDS vs Polyamide for Midline Abdominal Closure (PPMAC)

This study has been terminated.
(Unacceptable incidence of wound dehiscence in the PDS group)
Sponsor:
Information provided by:
Christian Medical College and Hospital, Ludhiana, India
ClinicalTrials.gov Identifier:
NCT00514566
First received: August 8, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00514566     History of Changes
Other Study ID Numbers: ChristianMCLudhiana
Study First Received: August 8, 2007
Last Updated: August 8, 2007
Health Authority: India: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014